Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Cost Effectiveness Analysis and Clinical Outcome of Nutritional Rehabilitation on Physical Functioning and Cardiometabolic Risk Profile in COPD Patients With Muscle Atrophy
To study in clinically stable Chronic Obstructive Pulmonary Disease (COPD) patients with
muscle atrophy:
1. The short-term effects of 4 months exercise training including nutritional
supplementation versus exercise training alone on physical functioning (skeletal muscle
strength and exercise capacity) and body composition.
2. The long-term effects of 4 months of exercise training and nutritional supplementation
followed by 8 months of nutritional counseling (with supplementation on advice) and
feedback on physical activity level versus 4 months of exercise training and 8 months
with feedback on physical activity level alone on physical functioning, body composition
and cardiometabolic risk profile;
3. The cost-effectiveness of exercise rehabilitation and nutritional intervention versus
exercise rehabilitation alone.
Rationale. Recent guidelines state that pulmonary rehabilitation should be part of integrated
care of patients with COPD and not limited to end stage disease. The investigators
hypothesize that clinically stable COPD patients muscle atrophy, irrespective of the severity
of airflow obstruction, show more pronounced long-term improvement in physical functioning
and cardiometabolic risk profile after a rehabilitation programme including nutritional
intervention (supplementation and counseling) than after a pulmonary rehabilitation programme
without nutritional intervention, at acceptable costs. Nutritional supplementation focuses on
enhancing the efficacy of the exercise training. Nutritional counseling aims at maintaining
energy balance and modulating cardiovascular disease risk.
Study design. The research aims will be addressed in a multi-centre, randomized, clinical
trial.
Phase A, Rehabilitation (4 months):
- Group 1: Supervised exercise training and 3 placebo nutritional supplements daily
- Group 2: Supervised exercise training and 3 nutritional supplements daily
Phase B, Maintenance (8 months):
- Group 1: Exercise counseling (2x)
- Group 2: Exercise counseling (2x), nutritional counseling (5x) (and 1 nutritional
supplement a day on indication)
Phase C, Follow-up (3 months):
- Group 1: no intervention
- Group 2: 1 nutritional supplement a day on request
Nature and extent of the burden and risks associated with participation and benefits. This
study aims to tailor pulmonary rehabilitation. Participants of group 1 are visiting their
rehabilitation centre 3 times for study related measurements within 15 months (2 times
feedback on physical activity, 1 measurement visit). Participants of group 2 will be asked to
visit their rehabilitation centre for 6 times (1 measurement visit, 3 times nutritional
counseling, 1 time for feedback on physical activity, 1 time for nutritional counseling and
feedback on physical activity combined) within 15 months. For both groups baseline
measurements and outcome measurements after rehabilitation are already included in the CIRO
rehabilitation programme.
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