High Protein Diet and Physical Activity in COPD

Jens Rikardt Andersen13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COPD

Interventions

interventionDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Pulmonary Medicine

Copenhagen, Denmark

Outcomes

Primary Outcomes

6-minute walk test (6MWD)

metres

Time frame: 7 weeks

hand grip strenght

Time frame: 7 weeks

Secondary Outcomes

Fat Free Mass (FFM)

Bioimpedance - kg

Time frame: 7 weeks

Dyspnoea after 6 minutes walk

Medical Research Council (MRC) dyspnoea scale (scores range from 0 to 5)

Time frame: 7 weks

Quality of life

self-administered COPD Assessment Test (CAT), 40-point scale

Time frame: 7 weeks

Data from ClinicalTrials.gov

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