Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:29 AM
Study NCT ID:
NCT00465660
Status:
UNKNOWN
Last Update Posted:
2007-04-25
First Post:
2007-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistive Exercise for Arthritic Cartilage Health (REACH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2009-07'}, 'lastUpdateSubmitDate': '2007-04-24', 'studyFirstSubmitDate': '2007-04-24', 'studyFirstSubmitQcDate': '2007-04-24', 'lastUpdatePostDateStruct': {'date': '2007-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Articular cartilage morphology following 6 months high intensity progressive resistance training'}], 'secondaryOutcomes': [{'measure': 'Muscle and fat cross-sectional area (CSA) (pre and post)'}, {'measure': 'Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post)'}, {'measure': 'Medications (pre, 3 months, & post)'}, {'measure': 'Body composition (pre, 3 months, & post)'}, {'measure': 'Balance; Physical function (pre, 3 months, & post)'}, {'measure': 'Questionnaires (pre, 3 months, & post):'}, {'measure': 'Habitual exercise (PASE)'}, {'measure': 'WOMAC index (pain, stiffness and functional ability)'}, {'measure': 'Depressive symptoms (Depression Scale)'}, {'measure': 'Quality of life (SF36)'}, {'measure': 'Confidence performing physical activity (Ewart)'}, {'measure': 'Demographics'}]}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Cartilage', 'Exercise', 'Progressive Resistance Training'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Female subjects over the age of 40 will be recruited and randomised into a progressive resistance training (PRT) or sham-exercise group. The PRT group will train at 80% of their peak strength, using Keiser pneumatic resistance machines, and progress approximately 3% per session. Strength will be re-assessed fortnightly. Exercises will target muscles around the hip and knee. The sham-exercise group will train on the same equipment as the PRT group except hip adduction, but without added resistance or progression. Both groups will train 3 days per week for roughly 45 minutes for 6 months.\n\nIt is hypothesised that high intensity PRT will decelerate the tibial and femoral cartilage degeneration in the knee affected most by OA.\n\nPrimary Outcome:\n\nArticular cartilage morphology following 6 months high intensity progressive resistance training\n\nSecondary Outcomes:\n\nMuscle and fat cross-sectional area (CSA) (pre and post) Muscle strength, power, endurance, and contraction velocity (pre, 3 months, \\& post) Medications (pre, 3 months, \\& post) Body composition (pre, 3 months, \\& post) Balance; Physical function (pre, 3 months, \\& post) Questionnaires (pre, 3 months, \\& post)\n\n* Habitual exercise (PASE) -WOMAC index (pain, stiffness and functional ability)\n* Depressive symptoms (Depression Scale) -Quality of life (SF36)\n* Confidence performing physical activity (Ewart) -Demographics'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female\n* Aged over 40 years old\n* Primary Osteoarthritis in at least one knee using standard criteria of the American College of Rheumatology (ACR) criteria for classification of clinical osteoarthritis\n* Ambulatory without human assistance\n* Willingness to be randomised to experiential or control group\n* Ability to attend scheduled exercise and testing sessions\n\nExclusion Criteria:\n\n* Regular exercise of any kind over the past 3 months (\\>1dpw).\n* Secondary osteoarthritis (traumatic or post-surgical), rheumatic disease, gouty or septic arthritis, Paget's disease, pseudogout, major congenital abnormalities, hemochromatosis, Wilson's disease and other rare forms of arthritis\n* Joint injury, injection or surgery within the past 6 months or knee joint replacement\n* Contraindications to MRI/Exercise"}, 'identificationModule': {'nctId': 'NCT00465660', 'briefTitle': 'Resistive Exercise for Arthritic Cartilage Health (REACH)', 'organization': {'class': 'OTHER', 'fullName': 'University of Sydney'}, 'officialTitle': 'The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients', 'orgStudyIdInfo': {'id': 'ACTRN012605000116628'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Progressive resistance training', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2140', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'University of Sydney', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Benedicte Vanwanseele, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sydney'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sydney', 'class': 'OTHER'}}}}