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

• Published in: Current controlled trials in cardiovascular medicine 2023-02, Vol.24 (1), p.86-86, Article 86
• Main Authors: Hegelund, Maria H, Ritz, Christian, Nielsen, Thyge L, Olsen, Mette F, Søborg, Christian, Braagaard, Lone, Mølgaard, Christian, Krogh-Madsen, Rikke, Lindegaard, Birgitte, Faurholt-Jepsen, Daniel
• Format: Article
• Language: English
• Subjects: Anxiety; Body composition; Cancer; Care and treatment; Chronic illnesses; Chronic obstructive pulmonary disease; Clinical trials; Data analysis; Data collection; Development and progression; Exercise; Health aspects; Hospitalization; Hospitals; Humans; Infections; Infectious diseases; Informed consent; Intervention; Lung diseases, Obstructive; Malnutrition - diagnosis; Malnutrition - therapy; Medical nutrition therapy; Mental health; Mortality; Nutrition therapy; Nutritional status; Nutritional Support; Nutritional therapy; Palliative treatment; Patient outcomes; Patient-centered care; Physical fitness; Proteins; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - therapy; Quality of Life; Randomized Controlled Trials as Topic; Registration; Registries; Services; Study Protocol
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07099-1

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. 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. 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. ClinicalTrials.gov NCT04873856 . Registered on May 3, 2021.