The Application of Inspiratory Muscle Training in Community-Dwelling Older Adults

July 14, 2026 updated by: Chung-Shan Hung, Hungkuang University

The Application of Inspiratory Muscle Training in Health Promotion and Disability Prevention for Community-Dwelling Older Adults

Background:

As individuals age, they experience a decline in muscle strength, particularly the respiratory muscles (such as the diaphragm), which not only affects respiratory efficiency but also may lead to postural instability and balance issues, limiting daily activity capacity. Inspiratory muscle training, by strengthening respiratory muscles like the diaphragm, improves breathing efficiency, reduces muscle fatigue and shortness of breath during exercise, and thus enhances physical performance and quality of life.

Moreover, inspiratory muscle training has a significant impact on balance. The diaphragm plays an essential role in maintaining postural stability, and training it can enhance the core muscles' contribution to postural balance, improve spinal support, and reduce the risk of falls. This makes it a promising non-pharmacological therapy for older adults. Therefore, inspiratory muscle training is considered a solution to improve the daily functional capacity, respiratory efficiency, and physical performance of elderly individuals.

Methods:

This study is a pilot study aimed at comparing muscle training (inspiratory muscle training, IMT) and incentive spirometer (Triflow) on respiratory muscle strength, pulmonary function, functional exercise capacity, quality of life, and physical activity in healthy older adults in the community. Due to limitations in manpower and resources, a convenience sampling method will be used, and participants will be recruited from 6-8 community centers, with cluster randomization at the community level. Each community center is expected to recruit 10-15 participants, with a total of 80 participants. The experimental group will use a handheld threshold trainer (n = 40, starting at 40% of Maximum Inspiratory Pressure, MIP), while the control group will use an inducible spirometer (n = 40, with the goal of raising one or more balls to the top). This study will explore the differences and potential of these two training methods in improving respiratory muscle strength, daily living abilities, exercise performance, and quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • Taichung, Taiwan, Taiwan, 973
        • Recruiting
        • HUNGKUANG University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged ≥65 years.
  2. Normal cognitive function
  3. No psychiatric disorders or Alzheimer's disease.
  4. Able to go out independently and perform self-care.
  5. Willing and able to participate throughout the health-promotion program.

Exclusion Criteria:

  1. Individuals whom a physician has determined have a serious illness for which exercise is not recommended.
  2. Individuals with functional limitations that may interfere with inspiratory muscle training (IMT) and/or maximal inspiratory pressure (MIP) measurement-for example, unstable angina, complex arrhythmias, rheumatologic disease, active infectious disease, or cognitive impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMT
Inspiratory muscle training for 8 weeks
Behavioral: IMT
Inspiratory muscle training was performed using the Dofin™ Breathing Trainer handheld threshold device (DT11). This two-in-one handheld threshold trainer enables training of both inspiratory and expiratory muscles and incorporates a spring and a colored ball to indicate breathing status and intensity. The DT11 provides a pressure range of 5-39 cmH₂O during inspiration and 4-33 cmH₂O during expiration.
Experimental: Triflow
Incentive spirometer practice for 8 weeks
Behavioral: Triflow
Triflow is a flow-oriented incentive spirometer driven by inspiratory flow rate. It contains a single colored ball that provides visual feedback of airflow, with the goal of raising the ball to the top chamber. Participants were instructed to inhale deeply at a sufficient flow rate-using abdominal or lower costal expansion-to lift the colored ball.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Muscle Strength
Time Frame: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)
Respiratory muscle strength will be measured with the GiO™ device for maximal inspiratory and expiratory pressure, yielding maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Three trials will be performed; the best value will be recorded and expressed in cmH₂O.
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Function
Time Frame: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).
Pulmonary function will be assessed using the CHESTGRAPH HI-301 spirometer. Outcomes include forced vital capacity (FVC, L), FVC % of predicted, forced expiratory volume in 1 second (FEV₁, L), FEV₁ % of predicted, and peak expiratory flow (PEF). Three maneuvers will be conducted, and the best value will be retained.
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).
Quality of Life and Confidence in Physical Exertion
Time Frame: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)
Quality of life will be evaluated using a questionnaire on daily life quality and confidence in physical exertion, focusing on how dyspnea and physical demands in everyday activities affect older adults' quality of life. Items cover challenges related to breathing in daily living, household tasks, community activities, and exercise, as well as participants' confidence and self-perceptions when facing physical challenges.
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)
30-Second Chair Stand Test
Time Frame: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)
This test assesses lower-limb muscular endurance for repetitive tasks such as stair climbing, walking, or rising from a chair; better performance is associated with a lower risk of falls. A stable, high-back chair without armrests is placed against a wall or in a safe area. After explaining the procedure, participants, with arms crossed over the chest, repeatedly stand up from and sit down on the chair after the start cue. During the test, the assessor assists with counting so participants know their progress. The number of full stands completed within 30 seconds is recorded.
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)
Get Up and Go Test
Time Frame: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).
With a 3-meter distance marked on the floor and an armless chair at one end, the participant begins seated. Time is measured from the moment the participant stands, walks to the 3-meter mark, turns, walks back, and sits down again. <10 seconds indicates normal mobility; >10 and ≤20 seconds suggests mild mobility impairment; 21-29 seconds indicates moderate impairment; >29 seconds reflects significant impairment.
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).
Berg Balance Scale (BBS)
Time Frame: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).
The BBS is used to assess balance and fall risk in older adults (≥65 years) and post-stroke individuals. It evaluates balance abilities commonly required in daily life, including maintaining various postures, transitioning between postures, and adjusting the center of mass.
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Assessment
Time Frame: Post-intervention (≤7 days after intervention end).
Feedback will be collected from participants and community site coordinators and analyzed qualitatively to inform the feasibility of implementing inspiratory muscle training among community-dwelling older adults.
Post-intervention (≤7 days after intervention end).
Perceived Exertion
Time Frame: Immediately after each intervention session.
Effort will be assessed using the Rating of Perceived Exertion (RPE) during exercise or training to capture participants' subjective intensity. RPE will be measured and recorded before and after training to evaluate training intensity and changes in perceived exertion. These measurements help tailor the program, ensure effectiveness and safety, and prevent excessive fatigue or injury.
Immediately after each intervention session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hungkuang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2025

Primary Completion (Actual)

April 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

July 14, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 114014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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