High Protein Diet and Physical Activity in COPD

Not Applicable

Completed

• Conditions: COPD
• Interventions: Dietary Supplement: intervention

• Registration Number: NCT04888182
• Lead Sponsor: Jens Rikardt Andersen

Brief Summary

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

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 Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-10-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	intervention	Individual nutritional guidance of a protein intake of ≥25 E%.

Primary Outcome Measures

Name	Time	Method
hand grip strenght	7 weeks	kg
6-minute walk test (6MWD)	7 weeks	metres

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Pulmonary Medicine; 🇩🇰 Copenhagen, Denmark