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

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ClinicalTrials.gov Identifier: NCT01344135
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : April 30, 2018
Sponsor:
Collaborators:
The Netherlands Asthma Foundation
Danone Research
Information provided by (Responsible Party):
Maastricht University Medical Center

April 12, 2011
April 28, 2011
April 30, 2018
September 2011
June 2015   (Final data collection date for primary outcome measure)
Skeletal muscle strength [ Time Frame: 0, 12 months ]
Skeletal muscle strength assessed by isokinetic dynamometry (Biodex®)
Same as current
Complete list of historical versions of study NCT01344135 on ClinicalTrials.gov Archive Site
  • Cardiometabolic risk profile [ Time Frame: 0, 4, 12 months ]
    • 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 ]
    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 ]
    Assessed by: -MRC-index: Medical Research Council dyspnoea scale
  • Body composition [ Time Frame: 0, 4, 12 months ]
    Assessed by - DEXA scan
  • Exercise capacity [ Time Frame: 0, 4, 12 months ]
    Assessed by: - Constant Work Rate Test (CWRT)
  • Plasma levels of supplemented (micro)nutrients [ Time Frame: 0, 4, 12 months ]
    Assessed by:
    • Plasma amino acids (leucine)
    • Vitamin D (plasma calcidiol 25(OH)D )
  • Bone mass density [ Time Frame: 0, 4, 12 months ]
    Assessed by: - DEXA scan
  • Physical activity [ Time Frame: 0, 4, 12, 15 months ]
    Assessed by: - Accelerometry
Same as current
Not Provided
Not Provided
 
Nutritional Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Muscle Atrophy
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Muscular Atrophy
  • 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
  • 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 Name: Non-active 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
  • Placebo Comparator: Group 1 (placebo control)
    60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
    Interventions:
    • Dietary Supplement: Placebo supplement
    • Behavioral: Feedback on physical activity level
  • Experimental: Group 2 (nutritional intervention)
    60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
    Interventions:
    • Dietary Supplement: Dietary supplementation
    • Behavioral: Nutritional counselling
    • Behavioral: Feedback on physical activity level
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
120
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01344135
MEC 11-3-004
Yes
Not Provided
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
  • The Netherlands Asthma Foundation
  • Danone Research
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
Maastricht University Medical Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP