Older Adults
Conditions
Keywords
inspiratory muscle training, cognition, Respiratory Muscle Training, Cognitive Function, older adults
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.
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
BEHAVIORALInspiratory 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.
Sponsors
Acibadem University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Expiratory Pressure (MEP) | 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. |
| Functional Capacity | 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. |
| Lower Extremity Physical Performance Assessed by Short Physical Performance Battery (SPPB) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed