Respiratory Training Intervention

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Elders
• Intervention / Treatment: Behavioral: breathing training

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; The control group is only taught the breathing training of abdominal diaphragmatic breathing.
Experimental: Intervention group ( breathing training with incentive spiromete); The experimental group will receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete.	Behavioral: breathing training; receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory capacity indicators	Indicator: FVC (forced vital capacity) ,FEV1(forced expiratory volume),MVV (maximal voluntary ventilation).	The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.
Dyspnea	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.	The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.
Quality of Life (OL)	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.	The questionnaire will be filled 3 times, during the first and fourth, and eighth weeks of the study.

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: Study Director: Hsiang Chu Pai, PhD, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): July 13, 2024
• Study Completion (Estimated): July 13, 2024

Study Registration Dates

• First Submitted: July 23, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: respiratory capacity; breathing training; abdominal diaphragmatic breathing; Quality of Life-
• Other Study ID Numbers: 202304111RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No