High Protein Diet and Physical Activity in COPD

Study Overview
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Brief Summary
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COPD outpatients with severe and very severe (grade III-IV) disease at risk of malnutrition commencing rehabilitation (7-10-week physical activity program) were randomized to receive a high protein diet (≥ 25 energy percentage) or standard care.

Detailed Description
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Peripheral muscle function was measured by 6MWD (6-meter-walk-distance) and handgrip strength; FFM was measured by bioimpedance, mid upper arm circumference, and mid-thigh circumference; quality of life was measured by CAT (????); and dyspnoea was measured by the Medical Research Council dyspnoea scale and Borg scores at baseline and after 12 weeks.

Official Title
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The Effect of High Protein Diet in Combination With Physical Activity in the Rehabilitation of Patients With Chronic Obstructive Pulmonary Disease (COPD) at Risk of Malnutrition- a Pilot Study

Conditions
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COPD

Intervention / Treatment
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* Dietary Supplement: intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed COPD stage III or stage IV Nutritional risk by screening (NRS-2002)(Kondrup et al, 2002) and/or low-fat free mass (FFMI) (≤ 15% for women and ≤ 16% for men) measured by Bioelectrical Impedance Analysis (BIA) Exclusion Criteria: Terminal phase of COPD Lung transplanted patients Severe Comorbidities influenzing the end-points (pancreatic insufficiency, severe hepatic failure, inflammatory gastrointestinal disease) Multiple sclerosis Any unwillingness or inability (e.g. not able to make notes of their nutritional intake, come to consultations or manage oral intake)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parellel, not blinded
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention<br>Individual nutritional guidance of a protein intake of ≥25 E%. | Dietary Supplement: intervention<br>* a protein intake of ≥25 E%. An oral nutritional supplement (containing 1570 kJ/100 g and 92 g protein/100 g. Atpro 200) was used as supplement to the patients' habitual diet.<br>|
| No Intervention: control<br>Free diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test (6MWD) | metres | 7 weeks | 
| hand grip strenght | kg | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Free Mass (FFM) | Bioimpedance - kg | 7 weeks | 
| Dyspnoea after 6 minutes walk | Medical Research Council (MRC) dyspnoea scale (scores range from 0 to 5) | 7 weks | 
| Quality of life | self-administered COPD Assessment Test (CAT), 40-point scale | 7 weeks |