Osteoarthritis Clinical Trial
Official title:
Efficacy of Strength and Aerobic Exercise on the Articular Cartilage of Patients With Mild and Moderate Knee Osteoarthritis Measured by T2 and T1 Rho MR Imaging - A Randomized Controlled Trial
NCT number | NCT01797679 |
Other study ID # | NFR213335/h10 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | March 2017 |
Verified date | January 2020 |
Source | University Hospital, Akershus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is the radiological component of an earlier registered trial under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2017 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Women and men aged 45-65 years - Clinical knee OA according to the American College of Rheumatology Clinical Criteria 17 - Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA) Exclusion Criteria: - Severe knee OA according to the Kellgren and Lawrence classification (grade 4) - Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities - Known coronary heart diseases or cancer - Body mass index > 35 - Scheduled for surgery in any joint - Known mental or psychologic diseases - Known drug abuse - Persons who already perform sports related moderate physical activity more than two times a week - Contraindications for magnetic resonance imaging (specific point list at Diagnostic Imaging Division, Akershus University Hospital) - Not speaking Norwegian |
Country | Name | City | State |
---|---|---|---|
Norway | Akershus University Hospital | Lorenskog |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Akershus | Hjelp24, Oslo University Hospital, South-Eastern Norway Regional Health Authority, The Research Council of Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Qualitative Cartilage Morphology Assessment | Indirect cartilage morphology will by assessed by X-ray Direct cartilage morphology will be assessed by MRI morphometry The biochemical composition of the cartilage will be assessed by relaxometry (T2 and T1 rho relaxation times) | One year | |
Secondary | Semiquantitative Cartilage Assessment | Using semiquantitative techniques, the clinical manifestations of osteoarthritis assessed by MRI such as: cartilage lesions and bone marrow lesions will be assessed and quantified by MRI. | One year |
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