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

This study is currently recruiting participants.
Verified September 2011 by Maastricht University Medical Center
Sponsor:
Collaborators:
The Netherlands Asthma Foundation
Danone Research
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01344135
First received: April 12, 2011
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Muscular Atrophy
 Dietary Supplement: Dietary supplementation
Dietary Supplement: Placebo supplement
Behavioral: Nutritional counselling
Behavioral: Feedback on physical activity level
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cost Effectiveness Analysis and Clinical Outcome of Nutritional Rehabilitation on Physical Functioning and Cardiometabolic Risk Profile in COPD Patients With Muscle Atrophy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Skeletal muscle strength [ Time Frame: 0, 12 months ] [ Designated as safety issue: No ]
    Skeletal muscle strength assessed by isokinetic dynamometry (Biodex®)


Secondary Outcome Measures:
  • Cardiometabolic risk profile [ Time Frame: 0, 4, 12 months ] [ Designated as safety issue: No ]
    • lipid profile (blood)
    • systemic inflammatory profile (blood)
    • blood pressure(hematometer)
    • HOMA index (blood)
    • visceral fat mass (DEXA)
    • AGEs skin (AGE reader)

  • Health related quality of life [ Time Frame: 0, 4, 12, 15 months ] [ Designated as safety issue: No ]

    Assessed by:

    • SGRQ: Saint George Respiratory Questionnaire
    • SF36: Short Form - 36
    • EQ5D: EuroQol 5 domains, extended with energy/fatique domain

  • Dyspnoea [ Time Frame: 0, 4, 12, 15 months ] [ Designated as safety issue: No ]

    Assessed by:

    -MRC-index: Medical Research Council dyspnoea scale


  • Body composition [ Time Frame: 0, 4, 12 months ] [ Designated as safety issue: No ]

    Assessed by

    - DEXA scan


  • Exercise capacity [ Time Frame: 0, 4, 12 months ] [ Designated as safety issue: No ]

    Assessed by:

    - Constant Work Rate Test (CWRT)


  • Plasma levels of supplemented (micro)nutrients [ Time Frame: 0, 4, 12 months ] [ Designated as safety issue: Yes ]

    Assessed by:

    • Plasma amino acids (leucine)
    • Vitamin D (plasma calcidiol 25(OH)D )

  • Bone mass density [ Time Frame: 0, 4, 12 months ] [ Designated as safety issue: No ]

    Assessed by:

    - DEXA scan


  • Physical activity [ Time Frame: 0, 4, 12, 15 months ] [ Designated as safety issue: No ]

    Assessed by:

    - Accelerometry



Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1 (placebo control)
60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
 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

Other Names:
  • Placebo supplement
  • Non-active supplement
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
Other Names:
  • Exercise
  • Accelerometry
Experimental: Group 2 (nutritional intervention)
60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
 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

Other Names:
  • Nutritional supplementation
  • Dietary supplement
  • Nutritional supplement
  • Food supplement
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.
Other Names:
  • Counselling
  • Motivational interviewing
  • Increasing self-regulation skills
  • Increasing perceived competence and autonomy
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
Other Names:
  • Exercise
  • Accelerometry

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344135

Locations
Netherlands
CIRO Recruiting
Horn, Limburg, Netherlands, 6085 NM
Contact: Erica Rutten, PhD     +31 47 5587651     ericarutten@ciro-horn.nl    
Sponsors and Collaborators
Maastricht University Medical Center
The Netherlands Asthma Foundation
Danone Research
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
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01344135     History of Changes
Other Study ID Numbers: MEC 11-3-004
Study First Received: April 12, 2011
Last Updated: September 12, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Pulmonary Disease, Chronic Obstructive
Muscular Atrophy
Nutritional rehabilitation
Counselling

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Lung Diseases
Respiration Disorders
Muscular Atrophy
Atrophy
Lung Diseases, Obstructive
Disease Attributes
 Pathologic Processes
Respiratory Tract Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013