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Completed

NCT Number: NCT05969678

Respiratory Training Intervention

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.

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Key information

Conditions

Elders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, 40201, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

breathing training

Behavioral

receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete

Primary outcomes

  1. respiratory capacity indicators

    Time frame: 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).

  2. Dyspnea

    Time frame: 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.

  3. Quality of Life (OL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Jun 5, 2025

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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