Nutritional Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Muscle Atrophy

Summary

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.

Conditions

• Pulmonary Disease, Chronic Obstructive
• Muscular Atrophy

Interventions

DIETARY_SUPPLEMENT

Dietary supplementation

Phase A, Rehabilitation (4 months): 3 nutritional supplements daily Phase B, Maintenance (8 months): nutritional supplementation on advice (1 supplement daily) Phase C, Follow-up (3 months): no supplementation

DIETARY_SUPPLEMENT

Placebo supplement

Phase A, Rehabilitation (4 months): 3 placebo nutritional supplements daily Phase B, Maintenance (8 months): No supplementation Phase C, Follow-up (3 months): No supplementation

BEHAVIORAL

Nutritional counselling

Phase A, Rehabilitation (4 months): No counselling Phase B, Maintenance (8 months): Nutritional counselling (4x) Phase C, Follow-up (3 months): No counselling Aim: 1. Optimising dietary intake to physical activity pattern and energy expenditure. 2. Minimize deterioration of dietary intake during acute exacerbations. 3. Optimize dietary lipid profile with respect to total fat intake; trans fatty acids and proportion of poly-unsaturated fatty acids to modulate cardiovascular risk and muscle fatty acid metabolism. 4. Increasing adherence/compliance by addressing issues like taste fatigue, gastro-intestinal symptoms, individual preferences and lifestyle.

BEHAVIORAL

Feedback on physical activity level

Phase A, Rehabilitation (4 months): No exercise counselling Phase B, Maintenance (8 months): Exercise counselling (2x) Phase C, Follow-up (3 months): No exercise counselling Aim: 1. Integration of exercise behaviour into daily routine 2. Improvement of self-regulation skills (e.g. self-monitoring, goal setting, action planning) 3. Increasing adherence/compliance by addressing issues like coping with difficult situation, individual preferences and lifestyle

Sponsors & Collaborators

• The Netherlands Asthma Foundation

  collaborator OTHER

• Danone Global Research & Innovation Center

  collaborator INDUSTRY

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Annemie Schols, Prof. · Maastricht UMC+ / NUTRIM, Respiratory Medicine

• Maureen Rutten, Dr. · Erasmus Medical Centre, Institute for Medical Technology Assessment

• Emiel FM Wouters, Prof. · Maastricht UMC+ and CIRO, Respiratory Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• Netherlands

Study Locations