Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-01 @ 3:37 AM
Study NCT ID:
NCT04980300
Status:
COMPLETED
Last Update Posted:
2025-01-01
First Post:
2021-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Delaware Physical Exercise and Activity for Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkw@udel.edu', 'phone': '302-831-7607', 'title': 'Daniel White', 'organization': 'University of Delaware'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from study enrollment until study completion at the 24 week follow up.', 'description': 'The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.', 'eventGroups': [{'id': 'EG000', 'title': 'Expanded Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nExpanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 44, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Brief Intervention', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nBrief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 10, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip/Thigh', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle/Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Moderate-to-vigorous Intensity Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '6.2'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '7.7'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '8.2'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '-3.6', 'upperLimit': '6.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome', 'description': 'Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided.\n\nUnits are in minutes/day of Moderate to vigorous intensity physical activity (MVPA), min 0, max 1440, with higher scores representing more time in MVPA', 'unitOfMeasure': 'min/day of MVPA', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for \\> 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88.'}, {'type': 'SECONDARY', 'title': 'Change in Treatment Beliefs of Physical Therapy: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Brief Intervention', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nBrief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '2.8'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '1.3'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '2.2'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '1.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy.\n\nScores of the TOA PT Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat (ITT) sample, which included all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Change in Treatment Beliefs of Physical Exercise: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '1.8'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '3.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity.\n\nScores of the TOA PE Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat sample, which included all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Change in Light Intensity Physical Activity (LPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '-22.6', 'upperLimit': '30.2'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '-22.0', 'upperLimit': '27.3'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '-3.4', 'groupId': 'OG000', 'lowerLimit': '-30.0', 'upperLimit': '23.1'}, {'value': '-13.1', 'groupId': 'OG001', 'lowerLimit': '-38.0', 'upperLimit': '11.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in minutes/week of LPA between baseline and both follow-up timepoints. Minutes/day of LPA can range from 0 minutes/day to 1,440 minutes/day (24 hours x 60 minutes).', 'unitOfMeasure': 'min/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for \\> 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88.'}, {'type': 'SECONDARY', 'title': 'Change in Steps/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '517.5', 'groupId': 'OG000', 'lowerLimit': '-252.8', 'upperLimit': '1287.8'}, {'value': '259.0', 'groupId': 'OG001', 'lowerLimit': '-462.2', 'upperLimit': '980.1'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '269.3', 'groupId': 'OG000', 'lowerLimit': '-505.7', 'upperLimit': '1044.4'}, {'value': '-206.5', 'groupId': 'OG001', 'lowerLimit': '-933.6', 'upperLimit': '520.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in average steps/day between baseline and both follow-up timepoints. Steps/day can be any value greater than or equal to 0. Valid data includes those who wore the ActiGraph for \\> 4 days.', 'unitOfMeasure': 'Steps/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for \\> 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88.'}, {'type': 'SECONDARY', 'title': 'Change in Treatment Beliefs of Physical Therapy: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '0.6'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '2.1'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '0.3'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy.\n\nScores of the TOA PT Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat sample, which included all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Change in Treatment Beliefs of Physical Exercise: Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '0.6'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '2.1'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '0.3'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity.\n\nScores of the TOA PE Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat sample, which included all subjects who were randomized.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Change in Knee Pain (Visual Analogue Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '-29.7', 'groupId': 'OG000', 'lowerLimit': '-40.5', 'upperLimit': '-18.9'}, {'value': '-8.8', 'groupId': 'OG001', 'lowerLimit': '-19.1', 'upperLimit': '1.6'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '-25.7', 'groupId': 'OG000', 'lowerLimit': '-36.8', 'upperLimit': '-14.7'}, {'value': '-14.2', 'groupId': 'OG001', 'lowerLimit': '-24.5', 'upperLimit': '-3.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Change in knee pain will be measured using a single-item Visual Analog Scale (VAS) question in which the participant will indicate their pain in each knee. Scores range from 0-100 where 0 is no pain and 100 is the worst pain imaginable. An index knee to be used for analysis is defined as the knee with worse pain at baseline.\n\nScores of the Knee pain Visual Analogue Scale are on a scale of 0 to 100 with higher scores mean worse outcome, i.e., more pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat sample, which included all subjects who were randomized.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Pain Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '16.2'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '8.9'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '15.6'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS Pain, min 0, max 100, with higher scores representing a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat sample, which included all subjects who were randomized.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Change in Treatment Expectations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': 'Pre-Randomization', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Post-Randomization', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after randomization', 'description': 'The participant will complete a Treatment Expectations Question, which asks the participant how effective they expect the intervention to be for their knee. This question will be collected at the baseline timepoint: right before and right after randomization. Answers will be expressed as frequencies and percentages for each of the following categories: No effect at all, Minimal improvement, Moderate improvement, Large improvement, and Complete recovery, as well as reported as an increase, decrease, or no change in treatment expectations.\n\nScore ranges from 1 to 5 with higher scores representing higher expectations of improvement following treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Change in Exercise Adherence Rating Scale (EARS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'The EARS was only collected in the Intervention Group at 12 weeks and 24 weeks.\n\nThe EARS includes 6 items whose total score ranges from 0 to 24, where a higher score indicates greater adherence and a score of 12 represents neutral agreement to exercise adherence.'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '15.1', 'spread': '6.1', 'groupId': 'OG000'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '11.1', 'spread': '6.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 24 weeks', 'description': 'For the Expanded Intervention, adherence to strengthening exercises and physical activity will be measured using the Exercise Adherence Rating Scale (EARS). The EARS includes 6 items whose total score ranges from 0 to 24, where a higher score indicates greater adherence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Symptoms Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '10.9'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '6.8'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '10.7'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS Symptoms, min 0, max 100, with higher scores representing a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat sample, which included all subjects who were randomized.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) ADL Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '18.6'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '10.2'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '15.7'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '10.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS ADL, min 0, max 100, with higher scores representing a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat sample, which included all subjects who were randomized.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Sports and Recreation Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '27.7'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '15.7'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '-5.6', 'upperLimit': '19.6'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '15.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS Sports and Recreation, min 0, max 100, with higher scores representing a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat sample, which included all subjects who were randomized.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Quality of Life Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nIntervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nControl: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'classes': [{'title': '12 weeks - Baseline', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '21.2'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '11.5'}]}]}, {'title': '24 weeks - Baseline', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '21.9'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '10.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS Quality of Life, min 0, max 100, with higher scores representing a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed our intention to treat sample, which included all subjects who were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Expanded Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nExpanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'FG001', 'title': 'Brief Intervention', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nBrief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}], 'periods': [{'title': 'Baseline to 12 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'comment': '24-week follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '12 Weeks to 24 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Expanded Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.\n\nExpanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.'}, {'id': 'BG001', 'title': 'Brief Intervention', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.\n\nBrief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '61.2', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '96.4', 'spread': '23.1', 'groupId': 'BG000'}, {'value': '95.9', 'spread': '22.1', 'groupId': 'BG001'}, {'value': '96.2', 'spread': '22.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant weight in kg', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '0.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Study participant height in meters', 'unitOfMeasure': 'Meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '34.4', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '35.7', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '35.0', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m squared', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-14', 'size': 595496, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_001.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2023-07-14T12:57', 'hasProtocol': True}, {'date': '2024-07-02', 'size': 867150, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_007.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-12T14:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2021-07-17', 'resultsFirstSubmitDate': '2024-04-07', 'studyFirstSubmitQcDate': '2021-07-17', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-19', 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Outcome: Change in Knee Pain (Visual Analogue Scale)', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Change in knee pain will be measured using a single-item Visual Analog Scale (VAS) question in which the participant will indicate their pain in each knee. Scores range from 0-100 where 0 is no pain and 100 is the worst pain imaginable. An index knee to be used for analysis is defined as the knee with worse pain at baseline.\n\nScores of the Knee pain Visual Analogue Scale are on a scale of 0 to 100 with higher scores mean worse outcome, i.e., more pain'}, {'measure': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Pain Subscale', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS Pain, min 0, max 100, with higher scores representing a better outcome'}, {'measure': 'Exploratory Outcome: Change in Treatment Expectations', 'timeFrame': 'Baseline and after randomization', 'description': 'The participant will complete a Treatment Expectations Question, which asks the participant how effective they expect the intervention to be for their knee. This question will be collected at the baseline timepoint: right before and right after randomization. Answers will be expressed as frequencies and percentages for each of the following categories: No effect at all, Minimal improvement, Moderate improvement, Large improvement, and Complete recovery, as well as reported as an increase, decrease, or no change in treatment expectations.\n\nScore ranges from 1 to 5 with higher scores representing higher expectations of improvement following treatment.'}, {'measure': 'Exploratory Outcome: Change in Exercise Adherence Rating Scale (EARS)', 'timeFrame': '12 weeks and 24 weeks', 'description': 'For the Expanded Intervention, adherence to strengthening exercises and physical activity will be measured using the Exercise Adherence Rating Scale (EARS). The EARS includes 6 items whose total score ranges from 0 to 24, where a higher score indicates greater adherence.'}, {'measure': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Symptoms Subscale', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS Symptoms, min 0, max 100, with higher scores representing a better outcome'}, {'measure': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) ADL Subscale', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS ADL, min 0, max 100, with higher scores representing a better outcome'}, {'measure': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Sports and Recreation Subscale', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS Sports and Recreation, min 0, max 100, with higher scores representing a better outcome'}, {'measure': 'Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Quality of Life Subscale', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \\& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.\n\nKOOS Quality of Life, min 0, max 100, with higher scores representing a better outcome'}], 'primaryOutcomes': [{'measure': 'Change in Moderate-to-vigorous Intensity Physical Activity', 'timeFrame': 'Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome', 'description': 'Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided.\n\nUnits are in minutes/day of Moderate to vigorous intensity physical activity (MVPA), min 0, max 1440, with higher scores representing more time in MVPA'}], 'secondaryOutcomes': [{'measure': 'Change in Treatment Beliefs of Physical Therapy: Positive', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy.\n\nScores of the TOA PT Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs'}, {'measure': 'Change in Treatment Beliefs of Physical Exercise: Positive', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity.\n\nScores of the TOA PE Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs'}, {'measure': 'Change in Light Intensity Physical Activity (LPA)', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in minutes/week of LPA between baseline and both follow-up timepoints. Minutes/day of LPA can range from 0 minutes/day to 1,440 minutes/day (24 hours x 60 minutes).'}, {'measure': 'Change in Steps/Day', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in average steps/day between baseline and both follow-up timepoints. Steps/day can be any value greater than or equal to 0. Valid data includes those who wore the ActiGraph for \\> 4 days.'}, {'measure': 'Change in Treatment Beliefs of Physical Therapy: Negative', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy.\n\nScores of the TOA PT Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs'}, {'measure': 'Change in Treatment Beliefs of Physical Exercise: Negative', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity.\n\nScores of the TOA PE Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Activity', 'Physical Therapy', 'Telehealth', 'Strengthening Exercise'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '37200067', 'type': 'DERIVED', 'citation': 'Aily JB, Copson J, Voinier D, Jakiela J, Hinman R, Grosch M, Noonan C, Armellini M, Schmitt L, White M, White D. Understanding Recruitment Yield From Social Media Advertisements and Associated Costs of a Telehealth Randomized Controlled Trial: Descriptive Study. J Med Internet Res. 2023 May 18;25:e41358. doi: 10.2196/41358.'}, {'pmid': '36200390', 'type': 'DERIVED', 'citation': 'Jakiela JT, Voinier D, Hinman RS, Copson J, Schmitt LA, Leonard TR, Aily JB, Bodt BA, White DK. Comparing an Expanded Versus Brief Telehealth Physical Therapist Intervention for Knee Osteoarthritis: Study Protocol for the Delaware PEAK Randomized Controlled Trial. Phys Ther. 2023 Feb 1;103(2):pzac139. doi: 10.1093/ptj/pzac139.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this project is to examine the efficacy of an innovative Telehealth Physical Therapy (PT) program for adults with knee osteoarthritis (OA) to increase physical activity over 12 weeks in adults with knee OA compared to a control group receiving web-based resources about knee OA. One hundred individuals with knee osteoarthritis (OA), who are over the age of 45, and are also looking to move more, will be randomized into a brief or expanded intervention group. The control includes an online, guided video orientation from a physical therapist to web resources for strengthening exercises, physical activity, and pain management strategies for knee OA. The intervention includes up to 5 online consultations with a physical therapist over a 12-week period who will prescribe strengthening exercises, physical activity goals, and pain management strategies for knee OA.', 'detailedDescription': 'Delaware PEAK (Physical therapy Exercise and Activity for Knee osteoarthritis) is a delivered remotely by a physical therapist over 5 one-on-one video conference (Zoom Platform) consultations lasting 45 to 60 minutes each over 12 weeks. Each consultation focuses on strengthening exercises, physical activity goals, and education to debunk common OA-related myths and misconceptions. Delaware PEAK utilizes a well-established behavioral counseling method, Motivational Interviewing, to increase self-efficacy (confidence) related to exercise, while delivering all aspects of the intervention.\n\nThe objective of this project is to examine the efficacy of Delaware PEAK to increase physical activity in adults with knee OA compared to a control group receiving web-based resources about knee OA and exercise. The rationale for our study is that there is a need to examine whether PEAK can directly target the mismatch between OA recommendations and practice patterns. Our central hypothesis is that Delaware PEAK will increase physical activity and will increase the belief that exercise is helpful and not harmful, compared with a control group receiving web-based OA treatment resources. Successful completion of this proposal will provide the evidence necessary to scale up this low-cost intervention, with the goal of increasing the number of adults who use exercise to manage their knee OA and thus reducing the burden of disease.\n\nThe primary endpoint of our study is to examine the efficacy of a physical therapist-delivered exercise intervention (Delaware PEAK) to increase MVPA over 12 weeks compared to a control group receiving web-based resources about knee OA and exercise.\n\nThe secondary analyses endpoint of our study is to examine the efficacy of a physical therapist-delivered exercise intervention (Delaware PEAK) to increase health beliefs in Physical Exercise and Physical Therapy, light physical activity (LPA), and steps per day, over 24 weeks compared to a control group receiving web-based resources about knee OA and exercise. We also will assess change in MVPA over 24 weeks.\n\nOur exploratory endpoints include change in pain, symptoms, function in activities of daily living, function in sport and recreation, and quality of life over 12 weeks and 24 weeks. We will also examine change in treatment expectations before and after randomization. Lastly, we will examine change in treatment adherence from 12 to 24 weeks among those in the expanded intervention group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. meet the National Institute for Health and Care Excellence Osteoarthritis (NICE) clinical criteria:\n\n 1. being at least 45 years of age;\n 2. having activity-related joint pain;\n 3. having morning stiffness ≤ 30 minutes;\n2. have a history of knee pain for at least 12 weeks;\n3. are interested in becoming more physically active;\n4. have either a cell phone or laptop/desktop computer with broadband internet connection and working email address; and\n5. are able to commit to the study for 12 weeks and willing to wear physical activity monitors\n6. live in the contiguous United States\n7. comfortable participating in a program delivered in English\n8. is able to safely participate in a moderate-intensity exercise as determined by a pre-exercise screen questionnaire.\n\nExclusion Criteria:\n\n1. regularly exercise more than 60 minutes/week; or\n2. has a scheduled knee or hip joint replacement; or\n3. has had physical therapy for knee OA in the past 6 months; or\n4. participated in a strength training program for the lower extremities in the past 6 months.'}, 'identificationModule': {'nctId': 'NCT04980300', 'acronym': 'PEAK', 'briefTitle': 'Delaware Physical Exercise and Activity for Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': 'Delaware Physical Exercise and Activity for Knee Osteoarthritis (PEAK)', 'orgStudyIdInfo': {'id': '1730922'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.', 'interventionNames': ['Behavioral: Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'University of Delaware', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}