Healthy Older Adults in the CommunityNCT07713589
The Application of Inspiratory Muscle Training in Community-Dwelling Older Adults
A study testing IMT and Triflow in people with Healthy Older Adults in the Community, run by Hungkuang University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Older Adults in the Community
- What is being tested?
- IMT and Triflow
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Sep 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged ≥65 years.
- Normal cognitive function
- No psychiatric disorders or Alzheimer's disease.
- Able to go out independently and perform self-care.
- Willing and able to participate throughout the health-promotion program.
Who cannot join
- Individuals whom a physician has determined have a serious illness for which exercise is not recommended.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
HUNGKUANG University
Taichung, Taiwan, 973
Chung-Shan Hung, 0800-4-26318652 ext. 3513, melody1088105@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Healthy Older Adults in the Community
- Being tested
- IMT, Triflow
- Keywords
- Inspiratory Muscle Training, Functional Exercise Capacity, Quality of Life, Pulmonary Function, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMTBehavioural
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.
TriflowBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| IMT | Experimental | Inspiratory muscle training for 8 weeks Receives: Behavioral: IMT |
| Triflow | Experimental | Incentive spirometer practice for 8 weeks Receives: Behavioral: Triflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength
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.
Measured: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)
Secondary outcomes (5)
Pulmonary Function
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.
Measured: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).
Quality of Life and Confidence in Physical Exertion
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.
Measured: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)
30-Second Chair Stand Test
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.
Measured: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)
Get Up and Go Test
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.
Measured: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).
Berg Balance Scale (BBS)
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.
Measured: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start23 Sep 2025
- Primary completion30 Apr 2026
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Older Adults in the CommunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hungkuang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung-Shan Hung, Hungkuang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713589
- Sponsor's protocol ID
- 114014
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Inspiratory Muscle Training in Health Promotion and Disability Prevention for Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT07713589
- Acronym / sponsor ID
- 114014
- Conditions
- Healthy Older Adults in the Community
- Keywords
- Inspiratory Muscle Training, Functional Exercise Capacity, Quality of Life, Pulmonary Function, older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hungkuang UniversityUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT | Experimental | Behavioral: IMTInspiratory muscle training for 8 weeks |
| Triflow | Experimental | Behavioral: TriflowIncentive spirometer practice for 8 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged ≥65 years.
- Normal cognitive function
- No psychiatric disorders or Alzheimer's disease.
- Able to go out independently and perform self-care.
- Willing and able to participate throughout the health-promotion program.
Key exclusion criteria (2 listed)
- Individuals whom a physician has determined have a serious illness for which exercise is not recommended.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMTInspiratory 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. | Behavioural | IMT |
| TriflowTriflow 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. | Behavioural | Triflow |
Primary outcome
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.
5 secondary outcomes
Pulmonary Function
Time frame: 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)
30-Second Chair Stand Test
Time frame: 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).
Berg Balance Scale (BBS)
Time frame: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT and Triflow in people with Healthy Older Adults in the Community, run by Hungkuang University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chung-Shan Hung (+886-4-26318652 ext. 3513, melody1088105@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength (time frame: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.