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Completed

NCT Number: NCT04888182

High Protein Diet and Physical Activity in COPD

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pulmonary Medicine

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intervention

Dietary 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.

Primary outcomes

  1. 6-minute walk test (6MWD)

    Time frame: 7 weeks

    metres

  2. hand grip strenght

    Time frame: 7 weeks

    kg

Secondary outcomes

  1. Fat Free Mass (FFM)

    Time frame: 7 weeks

    Bioimpedance - kg

  2. Dyspnoea after 6 minutes walk

    Time frame: 7 weks

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

  3. Quality of life

    Time frame: 7 weeks

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

Sponsors and collaborators

Lead sponsor

Jens Rikardt Andersen

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 17, 2021
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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