NCT05969678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

9 days

First QC Date

July 23, 2023

Last Update Submit

June 2, 2025

Conditions

Keywords

breathing trainingabdominal diaphragmatic breathingrespiratory capacityQuality of Life-

Outcome Measures

Primary Outcomes (3)

  • 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.

Study Arms (2)

Intervention group ( breathing training with incentive spiromete)

EXPERIMENTAL

The experimental group will receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete.

Behavioral: breathing training

control group

NO INTERVENTION

The control group is only taught the breathing training of abdominal diaphragmatic breathing.

Interventions

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

Intervention group ( breathing training with incentive spiromete)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, 40201, Taiwan

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Hsiang Chu Pai, PhD

    Chung Shan Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

August 1, 2023

Primary Completion

August 10, 2023

Study Completion

December 8, 2023

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations