Impact of Respiratory Muscle Training on Cognition in Older Adults | NCT07728279

NCT07728279

Overview

NCT ID: NCT07728279
Lead Sponsor: Acibadem UniversityOTHER
Official Title: The Effect of Respiratory Muscle Training on Cognitive Function in Older Adults: A Pilot Randomized Controlled Trial
Brief 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.

Status and Timeline

Status: Enrolling by invitation
Last Update Posted: Jul 28, 2026Actual
Start Date: Jul 24, 2026Estimated
Primary Completion Date: Nov 20, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 24Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: Acıbadem University

Similar Studies

Participant Group/Arms

Inspiratory Muscle Training GroupExperimental

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

Control GroupNo 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.