High Protein Diet and Physical Activity in COPD

NCT04888182 | Completed DMC

• 1 other identifier: BBH-KU 33
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• 6-minute walk test (6MWD)

  metres

  7 weeks

• hand grip strenght

  kg

  7 weeks

Secondary Outcomes (3)

• Fat Free Mass (FFM)

  7 weeks

• Dyspnoea after 6 minutes walk

  7 weks

• Quality of life

  7 weeks

Study Arms (2)

intervention

ACTIVE COMPARATOR

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

Dietary Supplement: intervention

control

NO INTERVENTION

Free diet

Interventions

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.

intervention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jens Rikardt Andersen: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

Department of Pulmonary Medicine

Copenhagen, 2400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36331152 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jens R Andersen

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Primary Investigator

Model Details: Randomized, parellel, not blinded

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)