Clinical trial NCT01344135: Nutritional Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Muscle Atrophy
Official title: Cost Effectiveness Analysis and Clinical Outcome of Nutritional Rehabilitation on Physical Functioning and Cardiometabolic Risk Profile in COPD Patients With Muscle Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Muscular Atrophy
Keywords: Pulmonary Disease, Chronic Obstructive
Muscular Atrophy
Nutritional rehabilitation
Counselling
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: The Netherlands Asthma Foundation
name: Danone Global Research & Innovation Center
First posted: 2011-04-28
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Chronic Obstructive Pulmonary Disease
* Muscle atrophy (a FFMI under the sex- and age-specific 25th percentile FFMI values, assessed by DEXA)
* Eligible for pulmonary rehabilitation

Exclusion Criteria:

* COPD patients under the age of 18;
* Allergy or intolerance to fish, milk or other components of the study product;
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements;
* Not able to stop current supplement use or if total use will be above safe upper limits;
* Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
* Pregnancy;
* Life threatening diseases like tuberculosis, carcinoma, AIDS (including HIV+), acute leukaemia etc.

Primary outcomes:
measure: Skeletal muscle strength
timeFrame: 0, 12 months
Secondary outcomes:
measure: Cardiometabolic risk profile
timeFrame: 0, 4, 12 months
measure: Health related quality of life
timeFrame: 0, 4, 12, 15 months
measure: Dyspnoea
timeFrame: 0, 4, 12, 15 months
measure: Body composition
timeFrame: 0, 4, 12 months
measure: Exercise capacity
timeFrame: 0, 4, 12 months
measure: Plasma levels of supplemented (micro)nutrients
timeFrame: 0, 4, 12 months
measure: Bone mass density
timeFrame: 0, 4, 12 months
measure: Physical activity
timeFrame: 0, 4, 12, 15 months
Other outcomes:
Locations:
city: Horn
country: Netherlands
facility: CIRO
state: Limburg
Study officials:
affiliation: Maastricht UMC+ / NUTRIM, Respiratory Medicine
name: Annemie Schols, Prof.
role: STUDY_DIRECTOR
affiliation: Erasmus Medical Centre, Institute for Medical Technology Assessment
name: Maureen Rutten, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht UMC+ and CIRO, Respiratory Medicine
name: Emiel FM Wouters, Prof.
role: PRINCIPAL_INVESTIGATOR
References: