None listed
Conditions
Brief summary
This is a pilot project which aims to test the feasibility of a larger trial in this area. This project is designed as a pilot randomised trial (RCT) to evaluate a group-based nutrition and exercise weight loss program supported by standardized self-management education. It is hypothesised that promoting modest, realistic weight loss in overweight older adults with osteoarthritis (OA) of the knee will improve function and slow disease progression.
Interventions
Intervention – 12-week lifestyle program which will (i) combine dietary modification and activity to achieve weight loss of at least 5% initial weight; (ii) use home-based training to comply with recommendations for exercise prescription in OA;(iii) include self efficacy, management and monitoring strategies and aspects of cognitive behaviour therapy to build capacity and confidence to make required lifestyle changes.
Sponsors
Prof Lynne Daniels
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
BMI > 27 kg/m2; Meets American College Rheumatology criteria for knee OA; patients whose X-ray joint space >2 mm at the narrowest point of the medial compartment and/or < 2mm of lateral compartment of the signal joint; ambulatory, no use of a walker, braces or crutches.
Exclusion criteria
Knee OA secondary to other bone or joint disease (permit secondary to knee trauma); the following procedures on the signal joint (i) < 3 months arthroscopy or intra-articular injections, (ii) < 2 years intra-articular surgery including trimming, (iii) <3 years for osteotomy; total menisectomy; chronic inflammatory joint disease including crystal arthropathies and OA of hip; planned knee replacement; any condition which will inhibit/contraindicate adherence to the diet and exercise program; participation in alternate formal exercise program; Mini-Mental score<24; Significant psychological distress or other barriers (eg frailty/illness) to effective participation, unable to understand study materials or complete questionnaires.
Outcome results
None listed