An interventional study of Inspiratory Muscle Training in Older Adults, sponsored by Acibadem University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Acibadem University · Not applicable, Interventional, and Treatment
The increase in chronic diseases associated with aging leads to various physical limitations in older adults, negatively impacting fall risk, hospitalization rates, and overall mortality. While Inspiratory Muscle Training (IMT) is frequently utilized in rehabilitation programs due to its low cost and ease of use to enhance respiratory muscle strength, balance, and functional capacity, its potential effects on cognitive function remain unexamined.
The primary objective of this pilot randomized controlled trial is to investigate the effect of an 8-week Inspiratory Muscle Training (IMT) program on cognitive function in older adults. A secondary objective is to examine the relationship between cardiovascular risk factors and respiratory muscle strength in this population.
Researchers hypothesize that an 8-week IMT intervention will have a significant effect on cognitive function in older adults compared to a control group. To test this hypothesis, a total of 24 eligible older adults will be randomly assigned to either perform daily breathing exercises using an external device for 8 weeks or maintain their routine daily activities. Both groups will be assessed at baseline and after the 8-week period to evaluate changes in cognitive, functional, and physical parameters.
The decline in respiratory muscle strength, diminished cardiovascular capacity, and postural control impairments seen with aging significantly increase the risk of falls and physical limitations. Recent evidence suggests that Inspiratory Muscle Training (IMT) not only enhances respiratory muscle function but also yields systemic benefits in older adults, including improvements in, postural balance, and cerebral blood flow.
Despite these physiological benefits, current literature predominantly focuses on respiratory or cardiovascular outcomes, leaving the potential impact of IMT on cognitive function in the geriatric population largely unexplored. This pilot randomized controlled trial aims to address this gap by evaluating the comprehensive effects of an 8-week IMT protocol.
Following baseline evaluations, eligible older adults aged 60 and above will be randomized into two arms. The experimental group will undergo a progressive, 8-week IMT program, transitioning from supervised sessions to unsupervised home-based training with regular compliance checks and workload adjustments based on their maximum inspiratory capacity. The control group will continue their standard daily living activities without a specific breathing intervention. The study is designed to primarily observe changes in cognitive performance, while also tracking respiratory endurance, functional capacity, and lower extremity physical performance throughout the study duration.
Acibadem University is the lead sponsor of 220 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Criteria for withdrawal from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will undergo an 8-week Inspiratory Muscle Training (IMT) program using an external threshold loading device. The protocol consists of 30 breaths performed twice a day. For the first two weeks, sessions will be supervised, and the initial workload will be set between 30% and 50% of the participant's baseline Maximal Inspiratory Pressure (MIP). From the third week, training will be unsupervised at home with weekly compliance checks. To ensure progressive overload, MIP will be re-evaluated at the start of the 3rd, 5th, and 7th weeks, and the device resistance will be adjusted to 50% of the new MIP.
Behavioral: Inspiratory Muscle Training
Participants allocated to this arm will not receive any specific breathing exercises or experimental interventions. They will be instructed to maintain their standard daily living activities throughout the 8-week study period. They will undergo the exact same baseline and post-intervention assessments as the experimental group to evaluate changes in cognitive function, respiratory muscle strength, endurance, functional capacity, and physical performance.
The intervention consists of an 8-week progressive Inspiratory Muscle Training (IMT) program utilizing a spring-loaded threshold device (POWERbreathe Medic Classic). The daily protocol requires participants to perform 30 breaths, twice a day. During the initial two weeks, training sessions are supervised, and the device resistance is set between 30% and 50% of the participant's baseline Maximal Inspiratory Pressure (MIP). For the remaining six weeks (weeks 3 to 8), participants perform the exercises unsupervised at home, accompanied by weekly compliance checks. A key distinguishing feature of this protocol is the progressive overload design: MIP is re-evaluated at the beginning of the 3rd, 5th, and 7th weeks, and the device's resistance is systematically adjusted to 50% of the newly measured MIP to ensure continuous physiological adaptation.
Also known as: IMT
Cognitive Function
Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA). The MoCA is a widely used screening tool for detecting cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive performance. A score of 26-30 is considered normal, 18-25 indicates mild cognitive impairment, 10-17 indicates moderate impairment, and 0-10 indicates severe cognitive impairment.
Time frame: At baseline, and Week-8
Maximal Inspiratory Pressure (MIP)
MIP will be measured in cmH2O using a digital pressure meter (MD Diagnostics). Participants will perform maximum inspiratory maneuvers while seated upright with a nose clip. The highest value from three maneuvers (with less than 10% variability) will be recorded. Higher values indicate greater inspiratory muscle strength.
Time frame: Baseline and Week 8
Maximal Expiratory Pressure (MEP)
Maximal Expiratory Pressure(MEP) will be measured in cmH2O using a digital pressure meter. Participants will perform maximum expiratory maneuvers. The highest value from three maneuvers (with less than 10% variability) will be recorded. Higher values indicate greater expiratory muscle strength.
Time frame: Baseline and Week 8
Functional Capacity
Functional Capacity Assessed by 6-Minute Walk Test (6MWT) Participants will be instructed to walk as fast as possible in a 30-meter straight corridor for 6 minutes. The test will be performed twice on the same day with a 30-minute rest interval, and the longer distance (in meters) will be recorded and used for analysis. Higher walking distances indicate better functional capacity.
Time frame: Baseline and Week 8
Lower Extremity Physical Performance Assessed by Short Physical Performance Battery (SPPB)
Lower Extremity Physical Performance Assessed by Short Physical Performance Battery(SPPB) evaluates lower extremity function, mobility, and fall risk through three components: standing balance (side-by-side, semi-tandem, and tandem stances for 10 seconds), gait speed (4-meter walk test), and lower limb strength (5-times sit-to-stand test). The total SPPB score ranges from 0 to 12, with higher scores indicating better lower extremity physical performance and lower risk of mobility limitation and falls.
Time frame: Baseline and Week 8
Comorbidity Burden Assessed by the Charlson Comorbidity Index (CCI)
Comorbidity Burden Assessed by the Charlson Comorbidity Index (CCI) predicts the 10-year mortality risk by weighting the severity of comorbid conditions. CCI scores range from 0 to 37, with 0 indicating no comorbidity and higher scores indicating a greater burden of comorbid diseases and a higher predicted mortality risk. Scores of 1-2 indicate mild comorbidity, whereas scores of 3 or higher indicate a substantially increased mortality risk.
Time frame: Baseline
Plan to share: No — Individual participant data (IPD) will not be shared because informed consent for secondary data sharing with third parties was not obtained from the participants, in accordance with the ethical approval.
Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Jul 2026 → Sep 2026, primary completion Nov 2026 → Mar 2027 and completion Jan 2027 → Apr 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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