Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Nutritional supplementation: Oral supplement (leucine, n-3 fatty acids, vitamin
D)
Similar general characteristics as current Respifor ® :
- Volume serving of 125 mL
- 187.5 kCal per 125 mL unit
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 tas
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Clinically stable COPD patients with muscle atrophy eligible for pulmonary rehabilitation. Based on recent studies in COPD and health reference groups, muscle atrophy is defined as a fat-free mass index (FFMI) under the sex- and age-specific 25th percentile FFMI values, assessed by DEXA. Subjects have to be aged over 18, may not get pregnant during the study and have to stop possible intake of current nutritional supplements.Eligible patients will be included after signing informed consent.
Exclusion criteria
Exclusion criteria: -COPD patients under the age of 18; -Allergy or intolerance to fish, milk or other product components; -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary parameter (measured at baseline and after 4 and 12 months): 1.Skeletal muscle strength -Isokinetic dynamometry (Biodex®) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters (at baseline, after 4 and 12 months): 1.Exercise capacity: -Constant work cycle ergometry (CWRT) at 70% of peak work rate 2. Body composition (total and appendicular FFM, fat mass and distribution) -DEXA scan 3.Cardiometabolic risk profile: -Lipid profile (blood) -Systemic inflammatory profile (blood) -Blood pressure (hematometer) -HOMA index (blood) 4.Plasma levels of supplemented (micro)nutrients: -Plasma amino acids (leucine) -Vitamin D (plasma calcidiol 25(OH)D ) 5. Bone mineral density: -DEXA scan 6.Health related quality of life (also measured after 15 months): -SGRQ: Saint George Respiratory Questionnaire -SF36: Short Form - 36 -EQ5D: EuroQol 5 domains, extended with energy/fatique domain 7.Dyspnoea (also measured after 15 months): -MRC-index: Medical Research Council dyspnoea scale 8. Physical activity (also measured after 15 months): - Accelerometry Other parameters (at baseline, after 4 and 12 months): 1. Demographics (only at baseline) 2. Medical history (only at baseline) 3. Medication use 4. Length and weight 5. Lungfunction (only at baseline an after 4 months): -Spirometry 6. Motivation regulation concerning physical acitivity and dietary intake (also measured after 15 months): - Self determination theory questionnaire 7.Psychological functioning (also measured after 15 months): -HADS: Hospital and Anxiety Depression Scale -MAS-30/version 2: Self-Management Ability Scale -IPQ-B: Brief Illness Perception Questionnaire -Dutch General Self-Efficacy Scale 8. Quality of health care (also measured after 15 months): - PACIC: Patient Assessment of Chronic Illness Care 9. Use of health care (also measured after 15 months): - Use of health care questionnaire 10. Dietary intake (also measured after 15 months):: - Dietary anamnesis 11. Safety parameters: -Vitamin D metabolism-related parameters: plasma calcium and parathyroid hormone (PTH) -Blood clotting parameters: prothrombin time (PT) and acti | — |
Countries
Netherlands
Outcome results
None listed