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

NCT01344135 | Completed DMC

• 1 other identifier: MEC 11-3-004
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

To study in clinically stable Chronic Obstructive Pulmonary Disease (COPD) patients with muscle atrophy:

1. 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. 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. 3.The cost-effectiveness of exercise rehabilitation and nutritional intervention versus exercise rehabilitation alone.

Conditions

Pulmonary Disease, Chronic Obstructive; Muscular Atrophy

Keywords

Pulmonary Disease, Chronic Obstructive; Muscular Atrophy; Nutritional rehabilitation; Counselling

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle strength

  Skeletal muscle strength assessed by isokinetic dynamometry (Biodex®)

  0, 12 months

Secondary Outcomes (8)

• Cardiometabolic risk profile

  0, 4, 12 months

• Health related quality of life

  0, 4, 12, 15 months

• Dyspnoea

  0, 4, 12, 15 months

• Body composition

  0, 4, 12 months

• Exercise capacity

  0, 4, 12 months

Study Arms (2)

Group 1 (placebo control)

PLACEBO COMPARATOR

60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation

Dietary Supplement: Placebo supplement; Behavioral: Feedback on physical activity level

Group 2 (nutritional intervention)

EXPERIMENTAL

60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation

Dietary Supplement: Dietary supplementation; Behavioral: Nutritional counselling; Behavioral: Feedback on physical activity level

Interventions

Dietary supplementation DIETARY_SUPPLEMENT

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

Also known as: Nutritional supplementation, Dietary supplement, Nutritional supplement, Food supplement

Group 2 (nutritional intervention)

Placebo supplement DIETARY_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

Also known as: Non-active supplement

Group 1 (placebo control)

Nutritional counselling BEHAVIORAL

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.

Also known as: Counselling, Motivational interviewing, Increasing self-regulation skills, Increasing perceived competence and autonomy

Group 2 (nutritional intervention)

Feedback on physical activity level BEHAVIORAL

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

Also known as: Exercise, Accelerometry

Group 1 (placebo control); Group 2 (nutritional intervention)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• The Netherlands Asthma Foundation: collaborator
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

CIRO

Horn, Limburg, 6085 NM, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Muscular Atrophy

Interventions

Dietary Supplements; Counseling; Motivational Interviewing; Exercise; Accelerometry

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Directive Counseling; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques

Study Officials

• Annemie Schols, Prof.

  Maastricht UMC+ / NUTRIM, Respiratory Medicine

  STUDY DIRECTOR

• Maureen Rutten, Dr.

  Erasmus Medical Centre, Institute for Medical Technology Assessment

  PRINCIPAL INVESTIGATOR

• Emiel FM Wouters, Prof.

  Maastricht UMC+ and CIRO, Respiratory Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 28, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 30, 2018

Record last verified: 2011-09

Locations

NL (1)