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Completed

NCT Number: NCT06112730

Nutritional Supplementation in Patients With Chronic Respiratory Disease

The aim of this study is to investigate the nutritional status of patients with chronic pulmonary disease undergoing regular outpatient pulmonary rehabilitation.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

About this study

Background:

Exercise limitation due to impaired respiratory function is a common problem for COPD patients, and reduced muscle mass and malnutrition can exacerbate symptoms, impacting their functional ability and quality of life. Underweight COPD patients have an increased risk of mortality and acute exacerbations. Therefore, monitoring the body composition, nutritional status, and metabolic state of COPD patients and providing adequate nutritional support are crucial aspects of COPD management.Compared to healthy older adults, COPD patients require higher protein intake. Most studies have focused on analyzing body composition, respiratory and limb muscle strength, exercise performance, physical activity, lung function, emotional perception, and self-perceived scales, with limited assessment and exploration of calorie intake. Moreover, calorie intake estimation has mostly relied on formulas, lacking personalized and accurate assessment through indirect calorimetry.

Study Design:

This study is a single-center, prospective, randomized controlled trial.

Methods:

COPD patients who meet the inclusion criteria will be enrolled and randomly assigned to either the nutritional supplementation intervention group (experimental group) or the standard pulmonary rehabilitation group (control group). The experimental group will receive personalized dietary guidelines based on indirect calorimetry assessment by a nutritionist, while the control group will undergo routine pulmonary rehabilitation without dietary intervention. The study will follow up for a duration of 12 weeks, collecting data on cardiopulmonary physiological parameters, body composition, muscle strength, exercise performance, and indirect calorimetry assessment. Additionally, we will calculate the differences in recommended calorie intake between formula estimation and indirect calorimetry.

Effect:

We anticipate that indirect calorimetry will yield different results for calorie estimation compared to weight estimation and the Harris-Benedict equation. The nutritional supplementation intervention is expected to lead to improved changes in body composition, enhanced exercise performance and muscle strength, as well as better cardiopulmonary physiological parameters and self-perceived ratings.

Key words:

Chronic obstructive pulmonary disease, pulmonary rehabilitation, nutritional supplementation, indirect calorimetry

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 45 and 80 years
  • A written informed consent
  • Pre-COPD or COPD stages I-IV as per the 2023 GOLD guidelines
  • Recieved pulmonary rehabilitation at least three months
  • Unwilling to nutritional outpatient assessment

Exclusion criteria

  • Diagnosed with neuromuscular diseases
  • Emergency room visits or hospitalizations for exacerbation of respiratory disease within three months
  • Inability to cooperate with cardiopulmonary exercise testing
  • Significant malnutrition or low BMI

Treatment and study plan

standard pulmonnary rehabilitation

Other

Undergo routine pulmonary rehabilitation without dietary intervention

Nutritional supplementation intervention

Other

Receive personalized dietary guidelines based on indirect calorimetry assessment

Primary outcomes

  1. Resting energy expenditure

    Time frame: 15 minutes

    Basal metabolic rate

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study title

Nutritional Supplementation With Indirect Calorimetry During Pulmonary Rehabilitation in Patients With Chronic Respiratory Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Feb 27, 2026

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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