Multidimensional individualized nutritional therapy for individuals with severe chronic obstructive pulmonary disease: study protocol for a registry-based randomized controlled trial

Maria H. Hegelund*, Christian Ritz, Thyge L. Nielsen, Mette F. Olsen, Christian Søborg, Lone Braagaard, Christian Mølgaard, Rikke Krogh-Madsen, Birgitte Lindegaard, Daniel Faurholt-Jepsen

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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Abstract

Background:
Individuals with severe chronic obstructive pulmonary disease (COPD) are often at risk of undernutrition with low health-related quality of life (HRQoL). Undernutrition can worsen COPD and other comorbidities, be an independent predictor of morbidity and functional decline resulting in increased healthcare consumption and increased risk of death. Especially exacerbations and acute infections result in unintentional weight loss. The aim is to investigate the effect of an individualized nutritional intervention among individuals with severe COPD. 

Methods:
An open-label randomized controlled trial with two parallel groups. Participants are recruited from the pulmonary outpatient clinic at the Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark, and randomly allocated to either the intervention (intervention + standard of care) or control group (standard of care). The intervention has a duration of 3 months and combines individual nutritional care with adherence support and practical tools. It contains 4 elements including an individual nutritional plan, regular contacts, adherence support, and weight diary. The primary outcome is a difference in HRQoL (EQ-5D-5L) between the intervention and control group 3 months after baseline. Difference in functional capacity (grip strength, 30-s stand chair test, and physical activity), disease-specific quality of life (COPD Assessment Test), anxiety and depression (Hospital Anxiety and Depression Scale), nutritional parameters (energy and protein intake), anthropometry (weight, body mass index, waist, hip, and upper arm circumference), body composition (total fat-free and fat mass and indices), and prognosis (exacerbations, oxygen therapy, hospital contacts, and mortality) 3 months after baseline will be included as secondary outcomes. Data will be collected through home visits at baseline and 1 and 3 months after baseline. 

Discussion:
Currently, nutritional care is a neglected area of outpatient care among individuals with severe COPD. If this patient-centered approach can demonstrate a positive impact on HRQoL, mortality, and hospital contacts, it should be recommended as part of end-of-life care for individuals with severe COPD. Trial registration: ClinicalTrials.gov NCT04873856. Registered on May 3, 2021.

Original languageEnglish
Article number86
JournalTrials
Volume24
Issue number1
Number of pages15
ISSN1745-6215
DOIs
Publication statusPublished - 6. Feb 2023

Bibliographical note

Funding Information:
The study received financial support from the external grants Grosserer L. F. Foghts Fond and Axel Muusfeldts Fond and an internal grant from the research council at Copenhagen University Hospital North Zealand, Denmark. The funders had no role in the study design and will have no role in data collection, data management, data analysis, interpretation of data, or in the decision of publication of the results.

Keywords

  • Body composition
  • Chronic obstructive pulmonary disease
  • Functional capacity
  • Mental health
  • Nutritional status
  • Nutritional therapy
  • Quality of life

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