Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT01700933
Status:
COMPLETED
Last Update Posted:
2017-09-21
First Post:
2012-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-response: Exercise Therapy on Hip Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC Index of Osteoarthritis (questionnaire)', 'timeFrame': '0 weeks, 8 weeks, 6 months postinterventional', 'description': 'WOMAC Index of Osteoarthritis (questionnaire)'}], 'secondaryOutcomes': [{'measure': 'HAD questionnaire', 'timeFrame': '0 weeks, 8 weeks, 6 months postinterventional'}, {'measure': 'Tampa Scale for Kinesiophobia', 'timeFrame': '0 weeks, 8 weeks, 6 months postinterventional'}, {'measure': 'Squats', 'timeFrame': '0 weeks, 8 weeks, 6 months postinterventional', 'description': 'Number of squats completed in 30 seconds.'}, {'measure': 'Stairs', 'timeFrame': '0 weeks, 8 weeks, 6 months postinterventional', 'description': 'Time used to walk up and down 12 steps.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise therapy'], 'conditions': ['Osteoarthritis, Hip']}, 'referencesModule': {'references': [{'pmid': '28532870', 'type': 'RESULT', 'citation': 'Osteras H, Paulsberg F, Olsen SE, Osteras B, Torstensen TA. Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study. J Bodyw Mov Ther. 2017 Apr;21(2):284-289. doi: 10.1016/j.jbmt.2016.06.016. Epub 2016 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability. The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a well-documented effect on pain and function in patients with osteoarthritis of the hip. It is sought an optimal dose of exercise, in which this study will help to investigate.\n\nWe hypothesize that an exercise program designed to have a high number of repetitions will benefit the outcome of the training in a more positive way than a low-repetition based program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least three month since debut of the disease\n* Age above 45 years\n* Ability to complete the intervention\n\nExclusion Criteria:\n\n* Pain above 4 on VAS during gait\n* Pregnancy\n* Autoimmune disease\n* Cardiovascular disease\n* Respiratory disease\n* Metabolic disease\n* Neurological signs\n* Planned hip-replacement surgery within the next year\n* Received exercise therapy within the last 3 months'}, 'identificationModule': {'nctId': 'NCT01700933', 'briefTitle': 'Dose-response: Exercise Therapy on Hip Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study', 'orgStudyIdInfo': {'id': 'DROAPS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High-dosage-group', 'interventionNames': ['Other: High-Dosage Exercise Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-dosage-group', 'interventionNames': ['Other: Low-Dosage Exercise Therapy']}], 'interventions': [{'name': 'High-Dosage Exercise Therapy', 'type': 'OTHER', 'description': 'Structure of the exercise program done three times per week, for eight weeks:\n\n5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)', 'armGroupLabels': ['High-dosage-group']}, {'name': 'Low-Dosage Exercise Therapy', 'type': 'OTHER', 'description': 'Structure of the exercise program done three times per week, for eight weeks:\n\n5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)', 'armGroupLabels': ['Low-dosage-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6154', 'city': 'Ørsta', 'country': 'Norway', 'facility': 'Fysioterapitjenesten i Ørsta', 'geoPoint': {'lat': 62.19983, 'lon': 6.12904}}], 'overallOfficials': [{'name': 'Håvard Østerås', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}