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临床试验/NCT04835558
NCT04835558已完成不适用

Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome; Evaluation by Incremental Load Test

Istanbul University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Incremental load test

研究概览

简要总结

Obesity hypoventilation syndrome (OHS) is defined as a combination of obesity [body mass index (BMI) ≥30 kg/m2], chronic daytime hypercapnia (PaCO2 >45 mm Hg), and sleep-apnea in the absence of other known causes of hypercapnia. Respiratory system compliance decreases and resistance increases in OHS. This causes increase in work of breathing and oxygen cost of breathing, which may result in respiratory muscle fatigue. Increase in respiratory workload and increase in resistance to respiration is expected to decrease in respiratory muscle endurance (RME) in subjects with OHS.

详细描述

In the literature, studies evaluating RME in subjects with OHS are limited. No study has been found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a control group, and to determine factors associated with respiratory muscle endurance.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
24 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with OHS
  • Obese subjects (30 < body mass index < 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score < 3)

排除标准

  • Severe respiratory disease
  • Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests

结局指标

主要结局

Incremental load test

时间窗: 1 day

Respiratory muscle endurance was evaluated by incremental load test. The incremental load test was performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).

次要结局

  • 6 minute walk test(1 day)
  • Pittsburg Sleep Quality Index(1 day)
  • Fatigue Severity Scale(1 day)
  • EQ-5D Health-Related Quality of Life Questionnaire(1 day)
  • Obesity and Weight Loss Quality of Life Instrument(1 day)
  • Mouth pressure measurements(1 day)
  • Epworth Sleepiness Scale(1 day)

研究者

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

Goksen Kuran Aslan

Assoc. Prof.

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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