The Effect of Respiratory Muscle Training on Cognitive Function in Older Adults: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cognitive Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 60 years and older
- •Ability to walk 10 meters independently
- •Literacy (ability to read and write)
排除标准
- •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.
研究组 & 干预措施
Inspiratory Muscle Training Group
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.
干预措施: Inspiratory Muscle Training (Behavioral)
Control Group
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.
结局指标
主要结局
Cognitive Function
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Ozge Hakli
Research Assistant
Acibadem University