High Protein Diet and Physical Activity in COPD

NCT ID: NCT04888182

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-10-01

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention

Individual nutritional guidance of a protein intake of ≥25 E%.

Group Type: ACTIVE_COMPARATOR

intervention

Intervention Type: 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.

control

Free diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

intervention

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

Jens Rikardt Andersen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Associate Professor, Primary Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jens R Andersen

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Department of Pulmonary Medicine

Copenhagen, , Denmark

Countries

Denmark

References

Mogelberg N, Tobberup R, Moller G, Godtfredsen NS, Norgaard A, Andersen JR. High-protein diet during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. Dan Med J. 2022 Oct 11;69(11):A03220185.

Reference Type: DERIVED

PMID: 36331152 (View on PubMed)

Other Identifiers

BBH-KU 33

Identifier Type: -

Identifier Source: org_study_id