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NCT Number: NCT07728279

Impact of Respiratory Muscle Training on Cognition in Older Adults

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.

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Key information

Conditions

Older Adults

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acıbadem University

Istanbul, İ̇stanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 60 years and older
  • Ability to walk 10 meters independently
  • Literacy (ability to read and write)

Exclusion criteria

  • 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:

  • 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.

Treatment and study plan

Inspiratory Muscle Training

Behavioral

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.

Other names: IMT

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Maximal Expiratory Pressure (MEP)

    Time frame: Baseline and Week 8

    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.

  2. Functional Capacity

    Time frame: Baseline and Week 8

    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.

  3. Lower Extremity Physical Performance Assessed by Short Physical Performance Battery (SPPB)

    Time frame: Baseline and Week 8

    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.

Other outcomes

  1. Comorbidity Burden Assessed by the Charlson Comorbidity Index (CCI)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

The Effect of Respiratory Muscle Training on Cognitive Function in Older Adults: A Pilot Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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