- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01344135
Nutritional Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Muscle Atrophy (NUTRAIN)
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:
- 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.
- 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;
- The cost-effectiveness of exercise rehabilitation and nutritional intervention versus exercise rehabilitation alone.
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Horn, Limburg, Netherlands, 6085 NM
- Ciro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Group 1 (placebo control)
60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
|
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
Other Names:
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:
Other Names:
|
EXPERIMENTAL: Group 2 (nutritional intervention)
60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
|
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:
Other Names:
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
Other Names:
Phase A, Rehabilitation (4 months): No counselling Phase B, Maintenance (8 months): Nutritional counselling (4x) Phase C, Follow-up (3 months): No counselling Aim:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal muscle strength
Time Frame: 0, 12 months
|
Skeletal muscle strength assessed by isokinetic dynamometry (Biodex®)
|
0, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiometabolic risk profile
Time Frame: 0, 4, 12 months
|
|
0, 4, 12 months
|
Health related quality of life
Time Frame: 0, 4, 12, 15 months
|
Assessed by:
|
0, 4, 12, 15 months
|
Dyspnoea
Time Frame: 0, 4, 12, 15 months
|
Assessed by: -MRC-index: Medical Research Council dyspnoea scale |
0, 4, 12, 15 months
|
Body composition
Time Frame: 0, 4, 12 months
|
Assessed by - DEXA scan |
0, 4, 12 months
|
Exercise capacity
Time Frame: 0, 4, 12 months
|
Assessed by: - Constant Work Rate Test (CWRT) |
0, 4, 12 months
|
Plasma levels of supplemented (micro)nutrients
Time Frame: 0, 4, 12 months
|
Assessed by:
|
0, 4, 12 months
|
Bone mass density
Time Frame: 0, 4, 12 months
|
Assessed by: - DEXA scan |
0, 4, 12 months
|
Physical activity
Time Frame: 0, 4, 12, 15 months
|
Assessed by: - Accelerometry |
0, 4, 12, 15 months
|
Collaborators and Investigators
Investigators
- Study Director: Annemie Schols, Prof., Maastricht UMC+ / NUTRIM, Respiratory Medicine
- Principal Investigator: Maureen Rutten, Dr., Erasmus Medical Centre, Institute for Medical Technology Assessment
- Principal Investigator: Emiel FM Wouters, Prof., Maastricht UMC+ and CIRO, Respiratory Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Neurologic Manifestations
- Disease Attributes
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Chronic Disease
- Muscular Atrophy
- Atrophy
Other Study ID Numbers
- MEC 11-3-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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