Ireland
--:--IST
Enrolling by invitation Not applicable

Impact of Respiratory Muscle Training on Cognition in Older Adults

NCT07728279 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-07-24
Last updated
2026-07-28

Condition(s) studied

Older Adults

Investigational drug(s) / intervention(s)

Inspiratory Muscle Training

Inspiratory Muscle Training: 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 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. 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Cognitive Function — 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) — 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.

Trial sites (1)

FacilityCityRegionStatus
Acıbadem University Istanbul İ̇stanbul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07728279 on ClinicalTrials.gov ↗ ← All trials in Turkey