The Application of Inspiratory Muscle Training in Community-Dwelling Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHungkuang University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged ≥65 years.
Normal cognitive function
No psychiatric disorders or Alzheimer's disease.
Able to go out independently and perform self-care.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
IMT
BehavioralInspiratory 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.
Triflow
BehavioralTriflow 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: IMTExperimental treatment 1 intervention
Group B: TriflowExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)Secondary outcomes
1
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.
Time frame
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).2
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.
Time frame
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)3
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.
Time frame
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)4
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.
Time frame
Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).Other outcomes
1
Feasibility Assessment
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.
Time frame
Post-intervention (≤7 days after intervention end).2
Perceived Exertion
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.
Time frame
Immediately after each intervention session.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov