A randomized controlled trial of exercise to prevent muscle mass and functional loss in elderly hemodialysis patients: Rationale, study design, and baseline sample.

Background: Elderly maintenance hemodialysis (MHD) patients exhibit muscle wasting and impaired physical function. This trial determines whether MHD patients benefit from a 12-week home-based exercise program, protein supplementation, or both.

Design: and Methods: This is a randomized, blinded controlled trial involving 60 elderly MHD patients with impaired exercise capacity and function. Patients are randomized into either a homebased exercise program or normal care over a 12-week period. Measures at baseline include peak VO, strength and body composition as well as cognitive and disease-specific questionnaires. Muscle biopsies are obtained and analyzed for protein signaling, expression of IGF-1, androgen receptors, and myostatin.

Results: At baseline, patient characteristics in the exercise and normal care groups were similar by age, gender and anthropomorphic measures. Peak VO was impaired (14.7 ± 3.3 ml/kg/min), representing 55 ± 14% of the age-predicted value. Six-minute walk distance was 322 ± 71 m, and the mean 1-min sit to stand test was 18 ± 8 repetitions, representing 69 ± 16% and 55 ± 22% of the age-predicted values, respectively. Indices of muscle function, including upper and lower body and hand grip strength all indicate marked impairment. Quality of life (QoL) using the SF36, the Beeson cognitive test, and KDQOL all suggest marked impairments compared to age-expected reference values for non-MHD patients.

Conclusions: Patients undergoing MHD exhibit markedly reduced physical function and QoL. Thus, there are potentially significant gains to be made through a program of aerobic and resistance exercise. We anticipate this trial will demonstrate that home-based exercise improves cardiopulmonary function, protein signaling and QoL, and increases muscle mass, strength, and body composition.