Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT02022566
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2013-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Structured Info and Adapted Exercise in OA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'therese.jonsson@med.lu.se', 'phone': '0046703360721', 'title': 'Physical therapist Therese Jönsson', 'organization': 'Lunds university'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 month', 'description': "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.", 'eventGroups': [{'id': 'EG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 0, 'seriousNumAtRisk': 195, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'No intervention', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Level of Physical Activity/Sedentary Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '562', 'groupId': 'OG000', 'lowerLimit': '523', 'upperLimit': '605'}, {'value': '572', 'groupId': 'OG001', 'lowerLimit': '505', 'upperLimit': '599'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '556', 'groupId': 'OG000', 'lowerLimit': '507', 'upperLimit': '602'}, {'value': '556', 'groupId': 'OG001', 'lowerLimit': '504', 'upperLimit': '592'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '552', 'groupId': 'OG000', 'lowerLimit': '499', 'upperLimit': '598'}, {'value': 'NA', 'comment': 'The control group is only measured with baseline and 3 month follow-up', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 3 months and 12 months', 'description': 'The level of physical activity will be monitored by a GT1M Actigraph which is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from the morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip. The account of minutes in sedentary time will be calculated and the average of minutes in one week will be used.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Level of Physical Activity/Low Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000', 'lowerLimit': '150', 'upperLimit': '214'}, {'value': '169', 'groupId': 'OG001', 'lowerLimit': '130', 'upperLimit': '218'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000', 'lowerLimit': '144', 'upperLimit': '205'}, {'value': '169', 'groupId': 'OG001', 'lowerLimit': '118', 'upperLimit': '220'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000', 'lowerLimit': '140', 'upperLimit': '228'}, {'value': 'NA', 'comment': 'The control group was only had 3 month follow-up', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Described elsewhere'}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 3 months and12 months', 'description': 'Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds).\n\nParticipants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Level of Physical Activity/Moderate-vigorous Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '52'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '30'}]}]}, {'title': '3 month', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '52'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '37'}]}]}, {'title': '12 month', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '52'}, {'value': 'NA', 'comment': 'The control group only had follow-up at 3 month', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 3 month and 12 month', 'description': 'Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds).\n\nParticipants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Realted Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '0.80'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.16', 'upperLimit': '0.73'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.80'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.73'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.80'}, {'value': 'NA', 'comment': 'The control group is only measured at baseline and 3 month follow-up', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 3 months and 12 months', 'description': 'To evaluate the health-related quality of life the EQ-5D-3L has been used. In this study, we have used the index of EQ-5D-3L with a British tariff. This scale is between (i.e., minimal value -0.594 (worst health), maximal value 1.00 (best health).', 'unitOfMeasure': 'eq-5d index', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '62'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '70'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '54'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '71'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '57'}, {'value': 'NA', 'comment': 'The control group only have 3 month follow-up.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 3 months and 12 months', 'description': 'Visual Analog Scale for Pain has been used to evaluate pain. This is a scale from 0-100 mm there higher scores indicating higher intensity of pain. We have asked for the average pain the last month.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Arthritis Self-efficacy Scale/Pain (ASES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '76'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '62'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '86'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '70'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '84'}, {'value': 'NA', 'comment': 'Control group only followed up at 3 month', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 3 months and 12 months', 'description': "The Arthritis Self-Efficacy Scale (ASES) is a widely used self-report measure of beliefs reflecting confidence in one's capacity to function despite pain and control pain or other symptoms of arthritis. ASES is scored on a 10-point Likert scale ranging from 10 (very uncertain=worst) to 100 (very certain=best).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Arthritis Self-efficacy Scale/Other Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '80'}, {'value': '61', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '70'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '86'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '46', 'upperLimit': '81'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '83'}, {'value': 'NA', 'comment': 'Control group only followed up at 3 month', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 3 months and 12 months', 'description': "The Arthritis Self-Efficacy Scale (ASES) is a widely used self-report measure of beliefs reflecting confidence in one's capacity to function despite pain and control pain or other symptoms of arthritis. ASES is scored on a 10-point Likert scale ranging from 10 (very uncertain=worst) to 100 (very certain=best).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'No intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '41'}]}]}], 'recruitmentDetails': 'Because of a large drop out from the Accelerometer assessment, we recruit more participants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Supported Self-management of Osteoarthrits Program', 'description': 'Treatment with an supported self-management program for osteoarthritis.\n\nA supported self management of osteoarthritis program: Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'No intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '10', 'groupId': 'BG000'}, {'value': '66', 'spread': '7', 'groupId': 'BG001'}, {'value': '64', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'men', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '5', 'groupId': 'BG000'}, {'value': '28', 'spread': '5', 'groupId': 'BG001'}, {'value': '28', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Joint', 'classes': [{'categories': [{'title': 'knee', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': 'hip', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'elementary school', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'high school', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'university', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Charnley Category (A=unilateral hip-OA, B=bilateral hip-OA, C=multiple joint OA', 'classes': [{'categories': [{'title': 'A', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'B', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'C', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sedentary daily minutes', 'classes': [{'categories': [{'measurements': [{'value': '562', 'groupId': 'BG000', 'lowerLimit': '523', 'upperLimit': '605'}, {'value': '572', 'groupId': 'BG001', 'lowerLimit': '505', 'upperLimit': '599'}, {'value': '565', 'groupId': 'BG002', 'lowerLimit': '520', 'upperLimit': '602'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Low activity daily minutes', 'classes': [{'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000', 'lowerLimit': '150', 'upperLimit': '214'}, {'value': '169', 'groupId': 'BG001', 'lowerLimit': '130', 'upperLimit': '218'}, {'value': '178', 'groupId': 'BG002', 'lowerLimit': '145', 'upperLimit': '215'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Moderate-vigorous activity daily minutes', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '52'}, {'value': '20', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '30'}, {'value': '30', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '45'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Visual Analogue Scale pain (0 to 100, 0=no pain, 100=worst imaginable pain', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '62'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '70'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'EuroQol 5 Dimension index, minimal value -0.594 (worst health), maximal value 1.00 (best health)', 'classes': [{'categories': [{'measurements': [{'value': '0.725', 'groupId': 'BG000', 'lowerLimit': '0.62', 'upperLimit': '0.796'}, {'value': '0.656', 'groupId': 'BG001', 'lowerLimit': '0.159', 'upperLimit': '0.727'}, {'value': '0.692', 'groupId': 'BG002', 'lowerLimit': '0.48', 'upperLimit': '0.757'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'EQ-5D index', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Arthritis Self-Efficacy Scale-other symptoms, Likert scale 10-100, (10 worst, 100 best)', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '80'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '70'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale (10-100)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Arthritis Self-Efficacy Scale-pain, Likert scale 10-100, 10 worst, 100 best', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '76'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '62'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '44', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale (10-100)', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'The intervention group have been a part of a supported self-management of osteoarthritis and the control group were sign to meet a orthopedic doctor because of problems from knee or hip.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2013-12-18', 'resultsFirstSubmitDate': '2019-03-25', 'studyFirstSubmitQcDate': '2013-12-27', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-13', 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Physical Activity/Sedentary Time', 'timeFrame': 'Baseline, 3 months and 12 months', 'description': 'The level of physical activity will be monitored by a GT1M Actigraph which is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from the morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip. The account of minutes in sedentary time will be calculated and the average of minutes in one week will be used.'}, {'measure': 'Level of Physical Activity/Low Activity', 'timeFrame': 'baseline, 3 months and12 months', 'description': 'Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds).\n\nParticipants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.'}, {'measure': 'Level of Physical Activity/Moderate-vigorous Activity', 'timeFrame': 'baseline, 3 month and 12 month', 'description': 'Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds).\n\nParticipants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.'}], 'secondaryOutcomes': [{'measure': 'Health Realted Quality of Life', 'timeFrame': 'baseline, 3 months and 12 months', 'description': 'To evaluate the health-related quality of life the EQ-5D-3L has been used. In this study, we have used the index of EQ-5D-3L with a British tariff. This scale is between (i.e., minimal value -0.594 (worst health), maximal value 1.00 (best health).'}, {'measure': 'Visual Analog Scale for Pain', 'timeFrame': 'baseline, 3 months and 12 months', 'description': 'Visual Analog Scale for Pain has been used to evaluate pain. This is a scale from 0-100 mm there higher scores indicating higher intensity of pain. We have asked for the average pain the last month.'}, {'measure': 'Arthritis Self-efficacy Scale/Pain (ASES)', 'timeFrame': 'baseline, 3 months and 12 months', 'description': "The Arthritis Self-Efficacy Scale (ASES) is a widely used self-report measure of beliefs reflecting confidence in one's capacity to function despite pain and control pain or other symptoms of arthritis. ASES is scored on a 10-point Likert scale ranging from 10 (very uncertain=worst) to 100 (very certain=best)."}]}, 'conditionsModule': {'keywords': ['Osteoarthritis knee', 'Osteoarthritis hip', 'Physical activity', 'accelerometer'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '30037339', 'type': 'DERIVED', 'citation': 'Jonsson T, Ekvall Hansson E, Thorstensson CA, Eek F, Bergman P, Dahlberg LE. The effect of education and supervised exercise on physical activity, pain, quality of life and self-efficacy - an intervention study with a reference group. BMC Musculoskelet Disord. 2018 Jun 21;19(1):198. doi: 10.1186/s12891-018-2098-3.'}]}, 'descriptionModule': {'briefSummary': 'Physical activity level is measured at baseline and after 3 and 12 months after structured information and individually adapted exercise for patients with osteoarthritis in hip or knee.\n\nThe hypothesis of this study is that a supported self management of osteoarthritis program will increase the level of physical activity in patients with osteoarthritis in hip or knee. The second hypothesis is that patients with osteoarthritis in knee will increase their level of physical activity more than patients with osteoarthritis in hip.', 'detailedDescription': "Osteoarthritis (OA) is one of our most common chronic joint disorders. The World Health Organization (WHO) has estimated that every second woman and every fourth man over the age of 60 suffer some form of OA. OA is most common in hands, knee, hip and back. OA is a rheumatic disorder which affects the whole joint and may start as early as in the age of 30. The main symptoms are pain, stiffness and decreased quality of life.\n\nThe primary goals of OA management are to reduce the symptoms. Patient education and exercises are recommended as basic treatment according to national as well as international guidelines.\n\nIt is known that the level of physical activity decreases with age and that woman are less physical active than men. A study of healthy women older than 56 years showed that the level of activity decreased by 10 minutes per year, for every five year increase in age. OA is more common in women and is an irreversible disease, which means that the proportion of older women with osteoarthritis is large.\n\nIn addition OA is the most common cause of inactivity among the elderly and many fear that activity will further damage the joints. Inactivity is a large risk factor for poor physical and psychological health as well as premature death. Level of physical activity in people with OA has mainly been evaluated by self-assessment questionnaires. People with hip OA are more active than people with knee OA and the correlation between the degree of radiographic changes and physical activity is weak. Only 30% with early OA of the knee in the age group 35-65 years meet the recommendations for physical activity performed at least 30 minutes per day of moderate intensity, five days per week, measured by an accelerometer.\n\nThe primary aim of this study is to determine the effects of structured information and individually adapted exercises, delivered as a supported self-management osteoarthritis program, on overall levels of physical activity of moderate and vigorous intensity in patients with hip or knee OA. The secondary aim is to compare the level of physical activity in patients with hip and knee OA.\n\nSupported self-management program for patients with osteoarthritis has been studied before and it's shown that it improves the quality of life, the physical function and decrease pain. No studies have investigated the effect of supported self-management on the level of physical activity.\n\nThis is an observational study with control group. Assessments are made at baseline and at 3 and 12 month after the supported self-management course.\n\nThe self-management program comprise three theoretical sessions, each of about 90 minutes, led by a physical therapist and held as group sessions with about 10 participants in each group. On the third session an osteoarthritis communicator participates. That is a person with osteoarthritis who communicate the lifestyle changes he/she have done to live a good life with OA. After the theoretical part the patients are offered an individually adapted exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist twice per week for 6 weeks. Patients are also encouraged to find one or two exercises to perform continuously as home exercises. During the program home exercise and other alternatives as changing activity, using walking sticks, pain management ect are introduced in order to maintain the level of physical activity over an extended period of time. The importance of being physically active for a long time is accentuated in all aspects of the patient education. The primary aim of the supported self-management program is to increase the level of physical activity and empower patients to manage their disease, avoid illness and live a good life despite osteoarthritis.\n\nPhysical activity is measured with an accelerometer at baseline, 3 month and 12 month. We will also study the correlation between objectivity measured physical activity with physical activity questionnaire (UCLA), quality of life (EQ-5D), pain (VAS 0-100) and comorbidity.\n\nAll subjects in our study are also registered in a Swedish national quality register called Better management of patients with osteoarthritis (BOA). Some of the data used in the present study are collected from the register."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 75 years old.\n2. Patients with clinically verified OA, coming to see a physical therapist for the Supported self-management of osteoarthritis program.\n\nExclusion Criteria:\n\n1. Other serious disorders causing hip or knee pain (e.g. tumor, rheumatic arthritis, sequel hip fracture).\n2. Other symptoms more aggravating than the OA problem (e.g. chronic pain, fibromyalgia, cardio-respiratory dysfunction, spinal condition).\n3. Total joint replacement surgery within the past 12 months.\n4. Other surgery of knee or hip within the past 3 months.\n5. Unable to read and understand Swedish and follow verbal and visual instructions.'}, 'identificationModule': {'nctId': 'NCT02022566', 'briefTitle': 'Effect of Structured Info and Adapted Exercise in OA', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'The Effect of Structured Information and Individually Adapted Exercise on Levels of Physical Activity Measured by Accelerometer in Patients With Knee or Hip Osteoarthritis - an Observational Study With Control Group.', 'orgStudyIdInfo': {'id': '747-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supported self-management of osteoarthrits program', 'description': 'Treatment with an supported self-management program for osteoarthritis.', 'interventionNames': ['Behavioral: A supported self management of osteoarthritis program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intervention'}], 'interventions': [{'name': 'A supported self management of osteoarthritis program', 'type': 'BEHAVIORAL', 'description': 'Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.', 'armGroupLabels': ['Supported self-management of osteoarthrits program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22241', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Skånes universitets sjukhus', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Carina A Thorstensson, Ass prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, {'name': 'The Swedish Rheumatism Ass', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}