Older AdultsNCT07728279
Impact of Respiratory Muscle Training on Cognition in Older Adults
A study testing Inspiratory Muscle Training in people with Older Adults, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Inspiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 15 Apr 2027
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 60 years and older
- Ability to walk 10 meters independently
- Literacy (ability to read and write)
Who cannot join
- Taking sedative or hypnotic medications,
- Having a neurological disorder (history of stroke, Parkinson's disease, MS, dementia),
- Presence of cardiovascular complications (individuals diagnosed with COPD, pulmonary diseases, uncontrolled hypertension),
- Postural abnormalities such as severe scoliosis or kyphosis,
- Having communication problems
- Criteria for withdrawal from the study:
Show all 10Show fewer
- Individuals who fail to attend 70% of the training sessions,
- Individuals who are unable to participate in the interim or final assessments,
- Individuals who develop an acute systemic illness,
- Individuals who wish to withdraw from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Respiratory Muscle Training on Cognitive Function in Older Adults: A Pilot Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Older Adults
- Being tested
- Inspiratory Muscle Training
- Keywords
- inspiratory muscle training, cognition, Respiratory Muscle Training, Cognitive Function, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingBehavioural
Also called IMT
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.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | 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. Receives: Behavioral: Inspiratory Muscle Training |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Week 8
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Sep 2026
- Primary completion20 Mar 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel arms: the experimental arm (Inspiratory Muscle Training) or the control arm (no intervention). Both arms will run concurrently for the 8-week study duration, with comprehensive assessments conducted for all participants at baseline and immediately following the 8-week period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Hakli, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728279
- Sponsor's protocol ID
- 2025-18-688
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ozdilek B, Kenangil G. Validation of the Turkish Version of the Montreal Cognitive Assessment Scale (MoCA-TR) in patients with Parkinson's disease. Clin Neuropsychol. 2014;28(2):333-43. doi: 10.1080/13854046.2014.881554. Epub 2014 Feb 17.
PubMed 24528299Keskinoglu P, Ucku R, Yener G, Yaka E, Kurt P, Tunca Z. Reliability and validity of revised Turkish version of Mini Mental State Examination (rMMSE-T) in community-dwelling educated and uneducated elderly. Int J Geriatr Psychiatry. 2009 Nov;24(11):1242-50. doi: 10.1002/gps.2252.
PubMed 19337986Mello ESF, Oliveira ALMB, Santanna TDC, Soares PPDS, Rodrigues GD. Updates in inspiratory muscle training for older adults: A systematic review. Arch Gerontol Geriatr. 2024 Dec;127:105579. doi: 10.1016/j.archger.2024.105579. Epub 2024 Jul 15.
PubMed 39032314Colon-Emeric CS, McDermott CL, Lee DS, Berry SD. Risk Assessment and Prevention of Falls in Older Community-Dwelling Adults: A Review. JAMA. 2024 Apr 23;331(16):1397-1406. doi: 10.1001/jama.2024.1416.
PubMed 38536167Cebria i Iranzo Md, Arnall DA, Igual Camacho C, Tomas JM. Effects of inspiratory muscle training and yoga breathing exercises on respiratory muscle function in institutionalized frail older adults: a randomized controlled trial. J Geriatr Phys Ther. 2014 Apr-Jun;37(2):65-75. doi: 10.1519/JPT.0b013e31829938bb.
PubMed 23835773
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiratory Muscle Training on Cognitive Function in Older Adults: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07728279
- Acronym / sponsor ID
- 2025-18-688
- Conditions
- Older Adults
- Keywords
- inspiratory muscle training, cognition, Respiratory Muscle Training, Cognitive Function, older adults
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 27 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel arms: the experimental arm (Inspiratory Muscle Training) or the control arm (no intervention). Both arms will run concurrently for the 8-week study duration, with comprehensive assessments conducted for all participants at baseline and immediately following the 8-week period.
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Behavioral: Inspiratory Muscle TrainingParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 60 years and older
- Ability to walk 10 meters independently
- Literacy (ability to read and write)
Key exclusion criteria (10 listed)
- Taking sedative or hypnotic medications,
- Having a neurological disorder (history of stroke, Parkinson's disease, MS, dementia),
- Presence of cardiovascular complications (individuals diagnosed with COPD, pulmonary diseases, uncontrolled hypertension),
- Postural abnormalities such as severe scoliosis or kyphosis,
- Having communication problems
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 |
|---|---|---|
| Inspiratory Muscle TrainingAlso: IMTThe 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. | Behavioural | Inspiratory Muscle Training Group |
Primary outcome
Cognitive Function
Time frame: At baseline, and Week-8
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.
Maximal Inspiratory Pressure (MIP)
Time frame: Baseline and Week 8
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.
3 secondary outcomes
Maximal Expiratory Pressure (MEP)
Time frame: Baseline and Week 8
Functional Capacity
Time frame: Baseline and Week 8
Lower Extremity Physical Performance Assessed by Short Physical Performance Battery (SPPB)
Time frame: Baseline and Week 8
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 4 Nov 2026.
- Background: PubMed 24528299Ozdilek B, Kenangil G. Validation of the Turkish Version of the Montreal Cognitive Assessment Scale (MoCA-TR) in patients with Parkinson's disease. Clin Neuropsychol. 2014;28(2):333-43. doi: 10.1080/13854046.2014.881554. Epub 2014 Feb 17.
- Background: PubMed 19337986Keskinoglu P, Ucku R, Yener G, Yaka E, Kurt P, Tunca Z. Reliability and validity of revised Turkish version of Mini Mental State Examination (rMMSE-T) in community-dwelling educated and uneducated elderly. Int J Geriatr Psychiatry. 2009 Nov;24(11):1242-50. doi: 10.1002/gps.2252.
- Background: PubMed 39032314Mello ESF, Oliveira ALMB, Santanna TDC, Soares PPDS, Rodrigues GD. Updates in inspiratory muscle training for older adults: A systematic review. Arch Gerontol Geriatr. 2024 Dec;127:105579. doi: 10.1016/j.archger.2024.105579. Epub 2024 Jul 15.
- Background: PubMed 38536167Colon-Emeric CS, McDermott CL, Lee DS, Berry SD. Risk Assessment and Prevention of Falls in Older Community-Dwelling Adults: A Review. JAMA. 2024 Apr 23;331(16):1397-1406. doi: 10.1001/jama.2024.1416.
- Background: PubMed 23835773Cebria i Iranzo Md, Arnall DA, Igual Camacho C, Tomas JM. Effects of inspiratory muscle training and yoga breathing exercises on respiratory muscle function in institutionalized frail older adults: a randomized controlled trial. J Geriatr Phys Ther. 2014 Apr-Jun;37(2):65-75. doi: 10.1519/JPT.0b013e31829938bb.
- Individual participant dataSharing planned: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Older Adults, run by Acibadem University at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 4 Nov 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: At baseline, and Week-8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07728279, which also lists 5 linked publications.
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 4 Nov 2026.