Impact of Respiratory Muscle Training on Cognition in Older Adults

NCT07728279 | Enrolling By Invitation

• 1 other identifier: 2025-18-688
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Older Adults

Keywords

inspiratory muscle training; cognition; Respiratory Muscle Training; Cognitive Function; older adults

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and Week 8

Secondary Outcomes (3)

• Maximal Expiratory Pressure (MEP)

  Baseline and Week 8

• Functional Capacity

  Baseline and Week 8

• Lower Extremity Physical Performance Assessed by Short Physical Performance Battery (SPPB)

  Baseline and Week 8

Other Outcomes (1)

• Comorbidity Burden Assessed by the Charlson Comorbidity Index (CCI)

  Baseline

Study Arms (2)

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.

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.

Interventions

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.

Also known as: IMT

Inspiratory Muscle Training Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University

Istanbul, İ̇stanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 24528299 BACKGROUND

• Keskinoglu 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.

  PMID: 19337986 BACKGROUND

• Mello 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.

  PMID: 39032314 BACKGROUND

• Colon-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.

  PMID: 38536167 BACKGROUND

• Cebria 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.

  PMID: 23835773 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)