Impact of Respiratory Muscle Training on Cognition in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inspiratory Muscle Training.
- Who it may be relevant to
- Registry conditions: Older Adults. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Respiratory Muscle Training on Cognitive Function in Older Adults: A Pilot Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral 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 exerc
Primary outcome measures
- Cognitive Function [Time frame: At baseline, and Week-8]
- Maximal Inspiratory Pressure (MIP) [Time frame: Baseline and Week 8]
Secondary outcome measures (3)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Acıbadem University — Istanbul
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. PMID 24528299
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07728279 · 2025-18-688