Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT01344135
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2011-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Muscle Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D061725', 'term': 'Accelerometry'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2011-04-12', 'studyFirstSubmitQcDate': '2011-04-27', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal muscle strength', 'timeFrame': '0, 12 months', 'description': 'Skeletal muscle strength assessed by isokinetic dynamometry (Biodex®)'}], 'secondaryOutcomes': [{'measure': 'Cardiometabolic risk profile', 'timeFrame': '0, 4, 12 months', 'description': '* lipid profile (blood)\n* systemic inflammatory profile (blood)\n* blood pressure(hematometer)\n* HOMA index (blood)\n* visceral fat mass (DEXA)\n* AGEs skin (AGE reader)'}, {'measure': 'Health related quality of life', 'timeFrame': '0, 4, 12, 15 months', 'description': 'Assessed by:\n\n* SGRQ: Saint George Respiratory Questionnaire\n* SF36: Short Form - 36\n* EQ5D: EuroQol 5 domains, extended with energy/fatique domain'}, {'measure': 'Dyspnoea', 'timeFrame': '0, 4, 12, 15 months', 'description': 'Assessed by:\n\n-MRC-index: Medical Research Council dyspnoea scale'}, {'measure': 'Body composition', 'timeFrame': '0, 4, 12 months', 'description': 'Assessed by\n\n\\- DEXA scan'}, {'measure': 'Exercise capacity', 'timeFrame': '0, 4, 12 months', 'description': 'Assessed by:\n\n\\- Constant Work Rate Test (CWRT)'}, {'measure': 'Plasma levels of supplemented (micro)nutrients', 'timeFrame': '0, 4, 12 months', 'description': 'Assessed by:\n\n* Plasma amino acids (leucine)\n* Vitamin D (plasma calcidiol 25(OH)D )'}, {'measure': 'Bone mass density', 'timeFrame': '0, 4, 12 months', 'description': 'Assessed by:\n\n\\- DEXA scan'}, {'measure': 'Physical activity', 'timeFrame': '0, 4, 12, 15 months', 'description': 'Assessed by:\n\n\\- Accelerometry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulmonary Disease, Chronic Obstructive', 'Muscular Atrophy', 'Nutritional rehabilitation', 'Counselling'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Muscular Atrophy']}, 'descriptionModule': {'briefSummary': 'To study in clinically stable Chronic Obstructive Pulmonary Disease (COPD) patients with muscle atrophy:\n\n1. 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.\n2. 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;\n3. The cost-effectiveness of exercise rehabilitation and nutritional intervention versus exercise rehabilitation alone.', 'detailedDescription': '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.\n\nStudy design. The research aims will be addressed in a multi-centre, randomized, clinical trial.\n\nPhase A, Rehabilitation (4 months):\n\n* Group 1: Supervised exercise training and 3 placebo nutritional supplements daily\n* Group 2: Supervised exercise training and 3 nutritional supplements daily\n\nPhase B, Maintenance (8 months):\n\n* Group 1: Exercise counseling (2x)\n* Group 2: Exercise counseling (2x), nutritional counseling (5x) (and 1 nutritional supplement a day on indication)\n\nPhase C, Follow-up (3 months):\n\n* Group 1: no intervention\n* Group 2: 1 nutritional supplement a day on request\n\nNature 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic Obstructive Pulmonary Disease\n* Muscle atrophy (a FFMI under the sex- and age-specific 25th percentile FFMI values, assessed by DEXA)\n* Eligible for pulmonary rehabilitation\n\nExclusion Criteria:\n\n* COPD patients under the age of 18;\n* Allergy or intolerance to fish, milk or other components of the study product;\n* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements;\n* Not able to stop current supplement use or if total use will be above safe upper limits;\n* Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;\n* Pregnancy;\n* Life threatening diseases like tuberculosis, carcinoma, AIDS (including HIV+), acute leukaemia etc."}, 'identificationModule': {'nctId': 'NCT01344135', 'acronym': 'NUTRAIN', 'briefTitle': 'Nutritional Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Muscle Atrophy', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Cost Effectiveness Analysis and Clinical Outcome of Nutritional Rehabilitation on Physical Functioning and Cardiometabolic Risk Profile in COPD Patients With Muscle Atrophy', 'orgStudyIdInfo': {'id': 'MEC 11-3-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1 (placebo control)', 'description': '60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation', 'interventionNames': ['Dietary Supplement: Placebo supplement', 'Behavioral: Feedback on physical activity level']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (nutritional intervention)', 'description': '60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation', 'interventionNames': ['Dietary Supplement: Dietary supplementation', 'Behavioral: Nutritional counselling', 'Behavioral: Feedback on physical activity level']}], 'interventions': [{'name': 'Dietary supplementation', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutritional supplementation', 'Dietary supplement', 'Nutritional supplement', 'Food supplement'], 'description': 'Phase A, Rehabilitation (4 months): 3 nutritional supplements daily\n\nPhase B, Maintenance (8 months): nutritional supplementation on advice (1 supplement daily)\n\nPhase C, Follow-up (3 months): no supplementation', 'armGroupLabels': ['Group 2 (nutritional intervention)']}, {'name': 'Placebo supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Non-active supplement'], 'description': 'Phase A, Rehabilitation (4 months): 3 placebo nutritional supplements daily\n\nPhase B, Maintenance (8 months): No supplementation\n\nPhase C, Follow-up (3 months): No supplementation', 'armGroupLabels': ['Group 1 (placebo control)']}, {'name': 'Nutritional counselling', 'type': 'BEHAVIORAL', 'otherNames': ['Counselling', 'Motivational interviewing', 'Increasing self-regulation skills', 'Increasing perceived competence and autonomy'], 'description': 'Phase A, Rehabilitation (4 months): No counselling\n\nPhase B, Maintenance (8 months): Nutritional counselling (4x)\n\nPhase C, Follow-up (3 months): No counselling\n\nAim:\n\n1. Optimising dietary intake to physical activity pattern and energy expenditure.\n2. Minimize deterioration of dietary intake during acute exacerbations.\n3. 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.\n4. Increasing adherence/compliance by addressing issues like taste fatigue, gastro-intestinal symptoms, individual preferences and lifestyle.', 'armGroupLabels': ['Group 2 (nutritional intervention)']}, {'name': 'Feedback on physical activity level', 'type': 'BEHAVIORAL', 'otherNames': ['Exercise', 'Accelerometry'], 'description': 'Phase A, Rehabilitation (4 months): No exercise counselling\n\nPhase B, Maintenance (8 months): Exercise counselling (2x)\n\nPhase C, Follow-up (3 months): No exercise counselling\n\nAim:\n\n1. Integration of exercise behaviour into daily routine\n2. Improvement of self-regulation skills (e.g. self-monitoring, goal setting, action planning)\n3. Increasing adherence/compliance by addressing issues like coping with difficult situation, individual preferences and lifestyle', 'armGroupLabels': ['Group 1 (placebo control)', 'Group 2 (nutritional intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6085 NM', 'city': 'Horn', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'CIRO', 'geoPoint': {'lat': 51.21, 'lon': 5.94583}}], 'overallOfficials': [{'name': 'Annemie Schols, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maastricht UMC+ / NUTRIM, Respiratory Medicine'}, {'name': 'Maureen Rutten, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Centre, Institute for Medical Technology Assessment'}, {'name': 'Emiel FM Wouters, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC+ and CIRO, Respiratory Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Netherlands Asthma Foundation', 'class': 'OTHER'}, {'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}