Clinical trial NCT05969678: Respiratory Training Intervention
Official title: Effects of Respiratory Training Intervention on Lung Capacity and Quality of Life of Community Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elders
Keywords: breathing training
abdominal diaphragmatic breathing
respiratory capacity
Quality of Life-
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 128
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Hemoptysis, pneumothorax, unstable cardiovascular status, chronic respiratory diseases (asthma, chronic obstructive pulmonary disease).
2. 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.
3. Suffering from infectious diseases: airborne such as: chickenpox, measles, tuberculosis, severe special infectious pneumonia influenza. Droplet transmission such as: pneumonia, influenza.

Primary outcomes:
measure: respiratory capacity indicators
timeFrame: The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.
measure: Dyspnea
timeFrame: The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.
measure: Quality of Life (OL)
timeFrame: The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University
name: Hsiang Chu Pai, PhD
role: STUDY_DIRECTOR
References: