Pulmonary Disease, Chronic ObstructiveNUTRAINNCT01344135
Nutritional Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Muscle Atrophy
A study testing Dietary supplementation, Nutritional counselling and Feedback on physical activity level in people with Pulmonary Disease, Chronic Obstructive and Muscular Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Muscular Atrophy
- What is being tested?
- Dietary supplementation, Nutritional counselling and Feedback on physical activity level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Dietary supplementation, Placebo supplement, Nutritional counselling, Feedback on physical activity level
- Keywords
- Pulmonary Disease, Chronic Obstructive, Muscular Atrophy, Nutritional rehabilitation, Counselling
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementationDietary supplement
Also called Nutritional supplementation, Dietary supplement, Nutritional supplement, Food 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
Placebo supplementDietary supplement
Also called Non-active 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
Nutritional counsellingBehavioural
Also called Counselling, Motivational interviewing, Increasing self-regulation skills, Increasing perceived competence and autonomy
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 levelBehavioural
Also called Exercise, Accelerometry
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (placebo control) | Placebo comparator | 60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation Receives: 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 Receives: Dietary Supplement: Dietary supplementation; Behavioral: Nutritional counselling; Behavioral: Feedback on physical activity level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle strength
Skeletal muscle strength assessed by isokinetic dynamometry (Biodex®)
Measured: 0, 12 months
Secondary outcomes (8)
Cardiometabolic risk profile
- lipid profile (blood)
- systemic inflammatory profile (blood)
- blood pressure(hematometer)
- HOMA index (blood)
- visceral fat mass (DEXA)
- AGEs skin (AGE reader)
Measured: 0, 4, 12 months
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
Measured: 0, 4, 12, 15 months
Dyspnoea
Assessed by:
-MRC-index: Medical Research Council dyspnoea scale
Measured: 0, 4, 12, 15 months
Body composition
Assessed by
- DEXA scan
Measured: 0, 4, 12 months
Exercise capacity
Assessed by:
- Constant Work Rate Test (CWRT)
Measured: 0, 4, 12 months
Plasma levels of supplemented (micro)nutrients
Assessed by:
- Plasma amino acids (leucine)
- Vitamin D (plasma calcidiol 25(OH)D )
Measured: 0, 4, 12 months
Bone mass density
Assessed by:
- DEXA scan
Measured: 0, 4, 12 months
Physical activity
Assessed by:
- Accelerometry
Measured: 0, 4, 12, 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Asthma Foundation, Danone Global Research & Innovation Center
- Responsible party
- Sponsor
- Investigators
- Annemie Schols, Prof., Study director, Maastricht UMC+ / NUTRIM, Respiratory MedicineMaureen Rutten, Dr., Principal investigator, Erasmus Medical Centre, Institute for Medical Technology AssessmentEmiel FM Wouters, Prof., Principal investigator, Maastricht UMC+ and CIRO, Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344135
- Sponsor's protocol ID
- MEC 11-3-004
- Acronym
- NUTRAIN
- Status last verified
- Sep 2011
- First submitted
- 12 Apr 2011
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness Analysis and Clinical Outcome of Nutritional Rehabilitation on Physical Functioning and Cardiometabolic Risk Profile in COPD Patients With Muscle Atrophy
- ClinicalTrials.gov ID
- NCT01344135
- Acronym / sponsor ID
- NUTRAIN / MEC 11-3-004
- Keywords
- Pulmonary Disease, Chronic Obstructive, Muscular Atrophy, Nutritional rehabilitation, Counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- The Netherlands Asthma Foundation, Danone Global Research & Innovation Center
- Study start
- Sep 2011 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (placebo control) | Placebo comparator | Dietary Supplement: Placebo supplement, Behavioral: Feedback on physical activity level60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation |
| Group 2 (nutritional intervention) | Experimental | Dietary Supplement: Dietary supplementation, Behavioral: Nutritional counselling, Behavioral: Feedback on physical activity level60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplementationAlso: Nutritional supplementation, Dietary supplement, Nutritional supplement, Food supplementPhase 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 | Dietary supplement | Group 2 (nutritional intervention) |
| Placebo supplementAlso: Non-active supplementPhase A, Rehabilitation (4 months): 3 placebo nutritional supplements daily Phase B, Maintenance (8 months): No supplementation Phase C, Follow-up (3 months): No supplementation | Dietary supplement | Group 1 (placebo control) |
| Nutritional counsellingAlso: Counselling, Motivational interviewing, Increasing self-regulation skills, Increasing perceived competence and autonomyPhase 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. | Behavioural | Group 2 (nutritional intervention) |
| Feedback on physical activity levelAlso: Exercise, AccelerometryPhase 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 | Behavioural | Group 1 (placebo control), Group 2 (nutritional intervention) |
Primary outcome
Skeletal muscle strength
Time frame: 0, 12 months
Skeletal muscle strength assessed by isokinetic dynamometry (Biodex®)
8 secondary outcomes
Cardiometabolic risk profile
Time frame: 0, 4, 12 months
Health related quality of life
Time frame: 0, 4, 12, 15 months
Dyspnoea
Time frame: 0, 4, 12, 15 months
Body composition
Time frame: 0, 4, 12 months
Exercise capacity
Time frame: 0, 4, 12 months
Plasma levels of supplemented (micro)nutrients
Time frame: 0, 4, 12 months
Bone mass density
Time frame: 0, 4, 12 months
Physical activity
Time frame: 0, 4, 12, 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemie Schols, Prof. study director
Maastricht UMC+ / NUTRIM, Respiratory Medicine
Maureen Rutten, Dr. principal investigator
Erasmus Medical Centre, Institute for Medical Technology Assessment
Emiel FM Wouters, Prof. principal investigator
Maastricht UMC+ and CIRO, Respiratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplementation, Nutritional counselling and Feedback on physical activity level in people with Pulmonary Disease, Chronic Obstructive and Muscular Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle strength (time frame: 0, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.