Osteoarthritis, Knee Clinical Trial
— CONEXOfficial title:
Effect of Physical Surroundings on Effects From Exercise as Treatment for Hip or Knee Pain: A Double-blind Randomized Controlled Clinical Trial
The study is designed to investigate the effect of physical surroundings on the effect of exercise therapy for knee and hip pain.
Status | Completed |
Enrollment | 103 |
Est. completion date | March 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
Inclusion Criteria: - Age: 35 years or older - Self-report of knee and/or hip pain within the last 3 months. - Willing and able to attend exercise therapy at the University of Southern Denmark, Odense M twice weekly. Exclusion Criteria: - Co-morbidities or contraindication prohibiting to participation in exercise therapy. - Unable to fill-out questionnaires, or to speak, read or understand Danish. - Already participating in exercise therapy*, having had surgery to the hip/knee within the last 3 months or on waiting list for joint surgery within the coming 6 months. (*defined as supervised exercise program by physiotherapist, systematic strength training etc. with duration of 6 weeks or more) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Swedish Research Council (funding), The Danish Rheumatism Association (funding) |
Denmark,
Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline in functional test: Single limb mini squat | Baseline, 8 weeks | No | |
Other | Change from baseline in functional test: Maximal number of knee bendings pr. 30 sec. | baseline, 8 weeks | No | |
Other | Change from baseline in functional test: Number of chair stands per. 30 sec. | baseline, 8 weeks | No | |
Other | Change from baseline in functional test: Timed 40 m walking test | baseline, 8 weeks | No | |
Other | Change from baseline in functional test: One leg hop for distance | Baseline, 8 weeks, | No | |
Other | Change from baseline in muscle strength, MVC knee extension | baseline, 8 weeks | No | |
Other | change from baseline in muscle strength, MVC, hip abduction | baseline, 8 weeks | No | |
Other | Change from baseline in aerobic capacity measured by a submaximal bicycle test by Aastrand & Saltin | Baseline, 8 weeks | No | |
Primary | Patients' Global Perceived Effect | Patients indicate their perception of the global effect of the intervention on a 7 point likert scale ranging from "substantially worse" to "no change" to "substantially improved". The scale is balanced around the 'no change' response with 3 steps in each direction, respectively deterioration or improvement. | 8 weeks | No |
Secondary | Change from baseline in KOOS (The Knee injury and Osteoarthritis Outcome Score) or HOOS (The Hip Dysfunction and Osteoarthritis Score), respectively | Baseline, 4 weeks, 8 weeks | No | |
Secondary | Change from baseline in The 36-item Short-Form Health Survey (SF-36) | Baseline, 4 weeks, 8 weeks | No | |
Secondary | Change from baseline in Arthritis Self-Efficacy Scale | A modified version of the Arthritis Self-Efficacy Scale consisting of 11 items scoring patient reported self-efficacy | baseline, 4 weeks, 8 weeks. | No |
Secondary | Patient satisfaction with physical surroundings | Patients are asked to indicate their level of satisfaction with different elements of the physical surroundings. | 8 weeks | No |
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