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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— NUTRAIN  

Official title:

Cost Effectiveness Analysis and Clinical Outcome of Nutritional Rehabilitation on Physical Functioning and Cardiometabolic Risk Profile in COPD Patients With Muscle Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344135
• Other study ID #: MEC 11-3-004
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: September 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Chronic Disease
• Lung Diseases
• Muscular Atrophy
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• 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: Optimising dietary intake to physical activity pattern and energy expenditure. Minimize deterioration of dietary intake during acute exacerbations. 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. Increasing adherence/compliance by addressing issues like taste fatigue, gastro-intestinal symptoms, individual preferences and lifestyle.
• 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: Integration of exercise behaviour into daily routine Improvement of self-regulation skills (e.g. self-monitoring, goal setting, action planning) Increasing adherence/compliance by addressing issues like coping with difficult situation, individual preferences and lifestyle

Locations

Country	Name	City	State
Netherlands	CIRO	Horn	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Danone Research, The Netherlands Asthma Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle strength	Skeletal muscle strength assessed by isokinetic dynamometry (Biodex®)	0, 12 months
Secondary	Cardiometabolic risk profile	lipid profile (blood); systemic inflammatory profile (blood); blood pressure(hematometer); HOMA index (blood); visceral fat mass (DEXA); AGEs skin (AGE reader)	0, 4, 12 months
Secondary	Health related quality of life	Assessed by: SGRQ: Saint George Respiratory Questionnaire; SF36: Short Form - 36; EQ5D: EuroQol 5 domains, extended with energy/fatique domain	0, 4, 12, 15 months
Secondary	Dyspnoea	Assessed by: -MRC-index: Medical Research Council dyspnoea scale	0, 4, 12, 15 months
Secondary	Body composition	Assessed by; - DEXA scan	0, 4, 12 months
Secondary	Exercise capacity	Assessed by: - Constant Work Rate Test (CWRT)	0, 4, 12 months
Secondary	Plasma levels of supplemented (micro)nutrients	Assessed by: Plasma amino acids (leucine); Vitamin D (plasma calcidiol 25(OH)D )	0, 4, 12 months
Secondary	Bone mass density	Assessed by: - DEXA scan	0, 4, 12 months
Secondary	Physical activity	Assessed by: - Accelerometry	0, 4, 12, 15 months