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High Protein Diet and Physical Activity in COPD

J

Jens Rikardt Andersen

Status

Completed

Conditions

COPD

Treatments

Dietary Supplement: intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04888182
BBH-KU 33

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

13 participants in 2 patient groups

intervention
Active Comparator group
Description:
Individual nutritional guidance of a protein intake of ≥25 E%.
Treatment:
Dietary Supplement: intervention
control
No Intervention group
Description:
Free diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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