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临床试验/NCT05969678
NCT05969678已完成不适用

Effects of Respiratory Training Intervention on Lung Capacity and Quality of Life of Community Elderly

Chung Shan Medical University2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年8月1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
128
试验地点
2
主要终点
Quality of Life (OL)

研究概览

简要总结

This study aims to examine the effect of abdominal diaphragmatic breathing combined with incentive spirometer breathing training on the lung capacity of elderly community residents.

详细描述

The research will be conducted in a community in central Taiwan. Inclusion criteria are people over the age of 65 in the community. All participants will be randomly assigned to either the experimental group or the control group. The experimental group will receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete. The control group is only taught the breathing training of abdominal diaphragmatic breathing. Four assessment tools will be used, including the demographic questionnaire, respiratory capacity indicators, Modified Medical Research Council (mMRC) Dyspnea Scale, and the World Health Organization Quality of Life-BREF Taiwan Version (WHOQOL-BREF; WHOQOL-BREF). Data analysis will be performed by independent sample t test, paired t test, and repeated measures analysis. All data analysis will be performed by SPSS version 22.0.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 65 years old
  • A person who is conscious and can communicate in Mandarin or Hokkien, and can cooperate with breathing exercises.
  • Agree to interview or fill out the questionnaire, and complete the consent form.

排除标准

  • Hemoptysis, pneumothorax, unstable cardiovascular status, chronic respiratory diseases (asthma, chronic obstructive pulmonary disease).
  • Recent myocardial infarction or pulmonary embolism, thoracic aortic aneurysm, abdominal aortic aneurysm or cerebral aneurysm, recent eye surgery, nausea or vomiting, recent chest or abdominal surgery.
  • Suffering from infectious diseases: airborne such as: chickenpox, measles, tuberculosis, severe special infectious pneumonia influenza. Droplet transmission such as: pneumonia, influenza.

结局指标

主要结局

Quality of Life (OL)

时间窗: The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.

The 28 items World Health Organization Quality of Life-BREF Taiwan Version (WHOQOL-BREF)WHOQOL-BREF) will be used to examine participants' quality of life. Each item is rated on a 5-point Likert-type scale ranging from 1 (not at all) to 4 (very agree). The total score is the sum of all item scores. Higher scores reflect greater quality of life.

respiratory capacity indicators

时间窗: The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.

Indicator: FVC (forced vital capacity) ,FEV1(forced expiratory volume),MVV (maximal voluntary ventilation).

Dyspnea

时间窗: The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.

Modified Medical Research Council (mMRC) Dyspnea Scale) will be used to assess participants' breathing condition. This scale consisting of five items containing statements about the impact of breathlessness on the individual . It ranges from grade 0 to 4. Higher scores reflect lower respiratory function condition.

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

Hsiang Chu Pai

Principal Investigator

Chung Shan Medical University

研究点 (2)

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