跳至主要内容
临床试验/NCT06112730
NCT06112730招募中不适用

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

Fu Jen Catholic University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Resting energy expenditure

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Resting energy expenditure

时间窗: 15 minutes

Basal metabolic rate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ke-Yun, Chao

Group leader of Respiratory Therapists

Fu Jen Catholic University

研究点 (2)

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