Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-24 @ 5:50 AM
Study NCT ID:
NCT02653768
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2016-01-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
STepped Exercise Program 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kelli.allen@va.gov', 'phone': '919-286-0411', 'title': 'Kelli Allen, Associate Director', 'phoneExt': '177090', 'organization': 'Center to Accelerate Discovery and Practice Transformation, Durham VA'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '15 months for each participant', 'description': 'Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.', 'eventGroups': [{'id': 'EG000', 'title': 'STEP-KOA', 'description': 'This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.\n\nStepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.\n\nSTEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.\n\nSTEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 3, 'seriousNumAtRisk': 230, 'deathsNumAffected': 1, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Arthritis Education (AE)', 'description': 'The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 0, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Fall with minor injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased hip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization due bypass of peripheral artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for lymphatic leak following peripheral artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitzalization for cardiac stents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall leading to injury (not study related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood clot in leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hernia surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization following car accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department Visit due to twisted ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergncy room visit due to swollen legs and chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent soreness following car accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalziation due to flu symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency room visit due to a cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to infection after liver biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer diagnosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency department visit for knee pain after falling out of bed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Torn ligament in knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mini-strokes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency department visit for heat stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for cardiac catheterization and complidcations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital visit due to high blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency department visit due to atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee replacement surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STEP-KOA', 'description': 'This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.\n\nStepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.\n\nSTEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.\n\nSTEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit'}, {'id': 'OG001', 'title': 'Arthritis Education (AE)', 'description': 'The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.'}], 'classes': [{'title': 'Mean Change Scores from Baseline to 3-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.85', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Mean changes scores from baseline to 6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.97', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Mean change scores from baseline to 9-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.46', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Mean change scores from 9 months to 15-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.02', 'spread': '1.38', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '-2.0', 'groupDescription': 'This analysis of between-group difference in change from baseline to 3-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '2.3', 'groupDescription': 'This is the analysis of between-group difference in change from baseline to 6-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.8', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '-3.2', 'groupDescription': 'This is the analysis of between-group difference in change from baseline to 9-month follow-up. This is the primary outcome assessment time point.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 3-month, 6-month, 9-month follow-ups. For STEP-KOA only, change from 9-month to 15-month follow-up.', 'description': 'This is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total scale range is 0-96, and higher scores mean a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat. Only the STEP-KOA group was assessed at 15 months. This was planned because the AE group could start receiving treatment after 9 months.'}, {'type': 'SECONDARY', 'title': '30-second Chair Stand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STEP-KOA', 'description': 'This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.\n\nStepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.\n\nSTEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.\n\nSTEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit'}, {'id': 'OG001', 'title': 'Arthritis Education (AE)', 'description': 'The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.3', 'groupDescription': 'This is the analysis between-group difference in change from baseline to 9-month follow-up for the 30 second chair stand.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 9-month follow-up', 'description': 'The 30 second stair stand asks participants to rise and sit back down in a chair as many times as they can during that time period, without using hands or arms for support. Higher scores mean better outcome (e.g. more stands in 30 seconds).', 'unitOfMeasure': 'Number of chair stands', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': '40m Fast-paced Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STEP-KOA', 'description': 'This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.\n\nStepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.\n\nSTEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.\n\nSTEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit'}, {'id': 'OG001', 'title': 'Arthritis Education (AE)', 'description': 'The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.72', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '1.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '1.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 9-month follow-up', 'description': 'The 40m fast-paced walk is a timed test of walking twice back and forth (as fast as participants are able) over a 10m distance. Lower scores mean better outcome (e.g. faster walking speed).', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'STEP-KOA', 'description': 'This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.\n\nStepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.\n\nSTEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.\n\nSTEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit'}, {'id': 'FG001', 'title': 'Arthritis Education (AE)', 'description': 'The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.'}], 'periods': [{'title': '3-Month Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}, {'title': '6-Month Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '21 participants withdrew/excluded by 3-months, others missed that assessment but remained in study', 'groupId': 'FG000', 'numSubjects': '209'}, {'comment': '2 participants withdrew/excluded by 3-months, others missed that assessment but remained in study', 'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}, {'title': '9-Month Follow-Up (Primary)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '34 withdrew/excluded before 9 months; others missed prior assessments but remained in study', 'groupId': 'FG000', 'numSubjects': '196'}, {'comment': '4 withdrew/excluded before 9 months; others missed prior assessments but remained in study', 'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '13 withdrew/refused before 9 months; others missed prior assessments but remained in study', 'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'STEP-KOA', 'description': 'This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.\n\nStepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA.\n\nSTEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.\n\nSTEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit'}, {'id': 'BG001', 'title': 'Arthritis Education (AE)', 'description': 'The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '142', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-14', 'size': 658992, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-24T18:22', 'hasProtocol': True}, {'date': '2016-10-24', 'size': 248415, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-16T11:26', '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': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2016-01-08', 'resultsFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-24', 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Change from baseline to 3-month, 6-month, 9-month follow-ups. For STEP-KOA only, change from 9-month to 15-month follow-up.', 'description': 'This is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total scale range is 0-96, and higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': '30-second Chair Stand', 'timeFrame': 'Change from baseline to 9-month follow-up', 'description': 'The 30 second stair stand asks participants to rise and sit back down in a chair as many times as they can during that time period, without using hands or arms for support. Higher scores mean better outcome (e.g. more stands in 30 seconds).'}, {'measure': '40m Fast-paced Walk', 'timeFrame': 'Change from baseline to 9-month follow-up', 'description': 'The 40m fast-paced walk is a timed test of walking twice back and forth (as fast as participants are able) over a 10m distance. Lower scores mean better outcome (e.g. faster walking speed).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoarthritis, Knee', 'Exercise'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '31138256', 'type': 'BACKGROUND', 'citation': 'Allen KD, Bongiorni D, Caves K, Coffman CJ, Floegel TA, Greysen HM, Hall KS, Heiderscheit B, Hoenig HM, Huffman KM, Morey MC, Ramasunder S, Severson H, Smith B, Van Houtven C, Woolson S. STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2019 May 28;20(1):254. doi: 10.1186/s12891-019-2627-8.'}, {'pmid': '33952263', 'type': 'RESULT', 'citation': 'Boucher NA, Zullig LL, Shepherd-Banigan M, Decosimo KP, Dadolf J, Choate A, Mahanna EP, Sperber NR, Wang V, Allen KA, Hastings SN, Van Houtven CH. Replicating an effective VA program to train and support family caregivers: a hybrid type III effectiveness-implementation design. BMC Health Serv Res. 2021 May 6;21(1):430. doi: 10.1186/s12913-021-06448-7.'}, {'pmid': '34842733', 'type': 'RESULT', 'citation': 'Hughes JM, Bartle JT, Choate AL, Mahanna EP, Meyer CL, Tucker MC, Wang V, Allen KD, Van Houtven CH, Hastings SN. Walking All over COVID-19: The Rapid Development of STRIDE in Your Room, an Innovative Approach to Enhance a Hospital-Based Walking Program during the Pandemic. Geriatrics (Basel). 2021 Nov 10;6(4):109. doi: 10.3390/geriatrics6040109.'}, {'pmid': '33902099', 'type': 'RESULT', 'citation': 'Beauchamp T, Arbeeva L, Cleveland RJ, Golightly YM, Hales DP, Hu DG, Allen KD. Accelerometer-Based Physical Activity Patterns and Associations With Outcomes Among Individuals With Osteoarthritis. J Clin Rheumatol. 2022 Mar 1;28(2):e415-e421. doi: 10.1097/RHU.0000000000001750.'}, {'pmid': '33370174', 'type': 'RESULT', 'citation': 'Allen KD, Woolson S, Hoenig HM, Bongiorni D, Byrd J, Caves K, Hall KS, Heiderscheit B, Hodges NJ, Huffman KM, Morey MC, Ramasunder S, Severson H, Van Houtven C, Abbate LM, Coffman CJ. Stepped Exercise Program for Patients With Knee Osteoarthritis : A Randomized Controlled Trial. Ann Intern Med. 2021 Mar;174(3):298-307. doi: 10.7326/M20-4447. Epub 2020 Dec 29.'}, {'pmid': '35365305', 'type': 'RESULT', 'citation': 'Kaufman BG, Allen KD, Coffman CJ, Woolson S, Caves K, Hall K, Hoenig HM, Huffman KM, Morey MC, Hodges NJ, Ramasunder S, van Houtven CH. Cost and Quality of Life Outcomes of the STepped Exercise Program for Patients With Knee OsteoArthritis Trial. Value Health. 2022 Apr;25(4):614-621. doi: 10.1016/j.jval.2021.09.018. Epub 2021 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among Veterans. Although exercise is known to improve pain, physical abilities, and other outcomes for patients who have knee OA, most individuals with this condition are physically inactive. Therefore there is a need to develop programs that will help Veterans and others with knee OA to increase activity levels. This study will examine a stepped approach to helping Veterans with knee OA to increase physical activity, with increasing levels of program intensity when needed for individual patients to meaningfully improve pain and physical function.', 'detailedDescription': 'Knee osteoarthritis (OA) is a leading cause of pain and disability among Veterans, and Department of Veterans Affairs health care users are the most severely affected. There is ample evidence that exercise improves pain, function, and other outcomes among patients with knee OA. However, the vast majority of individuals with knee OA are physically inactive. There is clearly a need to develop and implement programs that efficiently and effectively foster regular physical activity and improve key patient-centered outcomes among Veterans with knee OA. This objective of this study is to evaluate the effectiveness a novel STepped Exercise Program for Knee OsteoArthritis (STEP-KOA).\n\nThis will be a randomized controlled trial of n=345 Veterans with symptomatic knee OA in two VA Integrated Networks (VISN) 6 sites, with participants assigned to two study arms: STEP-KOA and Arthritis Education Control (AE). STEP-KOA will begin with three months of access to a low-resource internet-based exercise training program that uses patient-specific information to determine and deliver an appropriate personalized exercise plan (Step 1). Participants who do not meet response criteria for clinically meaningful improvement in pain and function after three months of Step 1 will additionally receive telephone calls from an exercise counselor for three months, to facilitate adherence and address barriers to physical activity (Step 2). Participants who still fail to meet response criteria after Step 2 will receive in-person physical therapy visits, which address specific functional impairments and further tailor exercise recommendations (Step 3). Outcomes will be assessed at baseline, 3-months, 6-months, and 9 months (primary outcome time point). Veterans in the AE group will be offered participation in STEP-KOA after completing study assessments. The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), a measure of lower extremity pain, stiffness and function. The secondary outcomes will be objective measures of physical function. The main study analyses will compare the STEP-KOA intervention to the AE control condition at follow-up time points. The investigators will also evaluate patient characteristics associated with the need for progression to each Step and will conduct a cost-effectiveness analysis of STEP-KOA. This stepped exercise intervention is matched with patient needs, and it also provides the VA with a potential approach for focusing limited physical therapy resources toward patients who do not respond adequately to initial, less resource intensive and costly strategies to improve physical activity and related outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran enrolled at the Durham VA Medical Center (VAMC)\n* Physician diagnosis of knee osteoarthritis\n* Current knee joint symptoms\n\nExclusion Criteria:\n\n* Currently meeting physical activity guidelines\n* Currently completing Physical Therapy (PT) visits for knee OA\n* Gout (in knee)\n* Rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease\n* Dementia\n* Psychosis\n* Active substance abuse disorder\n* Meniscus or anterior cruciate ligament (ACL) tear in the past 6 months\n* Total joint replacement, other major lower extremity surgery in the past 6 months or planned in the next 9 months\n* Severe hearing impairment\n* Serious/terminal illness\n* Other health problem that would prohibit participation in the study and/or warrant immediate PT\n* Current participation in another OA intervention study\n* Unstable angina\n* History of ventricular tachycardia\n* Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)\n* Uncontrolled hypertension (diastolic blood pressure \\>110 mm/Hg or systolic \\> 200mm/Hg)\n* Stroke with moderate to severe aphasia'}, 'identificationModule': {'nctId': 'NCT02653768', 'acronym': 'STEP-KOA', 'briefTitle': 'STepped Exercise Program for Knee OsteoArthritis', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'STepped Exercise Program for Knee Osteoarthritis (STEP-KOA)', 'orgStudyIdInfo': {'id': 'IIR 14-091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STEP-KOA', 'description': 'This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.', 'interventionNames': ['Behavioral: Stepped Exercise Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arthritis Education (AE)', 'description': 'Participants in the AE control group will receive low literacy educational materials via mail every two weeks. Because STEP-KOA is a multi-component intervention, with participants receiving different numbers of Steps, it is not possible to implement a control condition that will mirror the exact intervention "dose" received by all participants in the STEP-KOA group. However, AE will achieve the goal of providing an active, OA-related control condition.', 'interventionNames': ['Behavioral: Arthritis Education']}], 'interventions': [{'name': 'Stepped Exercise Program', 'type': 'BEHAVIORAL', 'otherNames': ['STEP-KOA'], 'description': 'STEP 1: Participants have access to an internet-based exercise program for knee OA.\n\nSTEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.\n\nSTEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit', 'armGroupLabels': ['STEP-KOA']}, {'name': 'Arthritis Education', 'type': 'BEHAVIORAL', 'otherNames': ['AE'], 'description': 'The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to OA and its management, based on established treatment guidelines.', 'armGroupLabels': ['Arthritis Education (AE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705-3875', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Kelli Dominick Allen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA Medical Center, Durham, NC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}