Effects of an exercise programme for chronically ill and mobility-restricted elderly with structured support by the general practitioner's practice (HOMEfit) - study protocol of a randomised controlled trial

BACKGROUND: Exercise programmes can be administered successfully as therapeutic agents to patients with a number of chronic diseases and help to improve physical functioning in older adults. Usually, such programmes target either healthy and mobile community-dwelling seniors or elderly individuals living in nursing institutions or special residences. Chronically ill or mobility-restricted individuals, however, are difficult to reach when they live in their own homes. A pilot study has shown good feasibility of a home-based exercise programme that is delivered to this target group through cooperation between general practitioners and exercise therapists. A logical next step involves evaluation of the effects of the programme. METHODS/DESIGN: The study is designed as a randomised controlled trial. We plan to recruit 210 patients (≥ 70 years) in about 15 general practices. The experimental intervention (duration 12 weeks)-a multidimensional home-based exercise programme-is delivered to the participant by an exercise therapist in counselling sessions at the general practitioner's practice and on the telephone. It is based on methods and strategies for facilitating behaviour change according to the Health Action Process Approach (HAPA). The control intervention-baseline physical activities-differs from the experimental intervention with regard to content of the counselling sessions as well as to content and frequency of the promoted activities. Primary outcome is functional lower body strength measured by the "chair-rise" test. Secondary outcomes are: physical function (battery of motor tests), physical activity (step count), health-related quality of life (SF-8), fall-related self-efficacy (FES-I), and exercise self-efficacy (SSA-Scale). The hypothesis that there will be differences between the two groups (experimental/control) with respect to post-interventional chair-rise time will be tested using an ANCOVA with chair-rise time at baseline, treatment group, and study centre effects as explanatory variables. Analysis of the data will be undertaken using the principle of intention-to-treat. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17727272.