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临床试验/NCT07713589
NCT07713589招募中不适用

The Application of Inspiratory Muscle Training in Health Promotion and Disability Prevention for Community-Dwelling Older Adults

Hungkuang University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Respiratory Muscle Strength

研究概览

简要总结

Background:

As individuals age, they experience a decline in muscle strength, particularly the respiratory muscles (such as the diaphragm), which not only affects respiratory efficiency but also may lead to postural instability and balance issues, limiting daily activity capacity. Inspiratory muscle training, by strengthening respiratory muscles like the diaphragm, improves breathing efficiency, reduces muscle fatigue and shortness of breath during exercise, and thus enhances physical performance and quality of life.

Moreover, inspiratory muscle training has a significant impact on balance. The diaphragm plays an essential role in maintaining postural stability, and training it can enhance the core muscles' contribution to postural balance, improve spinal support, and reduce the risk of falls. This makes it a promising non-pharmacological therapy for older adults. Therefore, inspiratory muscle training is considered a solution to improve the daily functional capacity, respiratory efficiency, and physical performance of elderly individuals.

Methods:

This study is a pilot study aimed at comparing muscle training (inspiratory muscle training, IMT) and incentive spirometer (Triflow) on respiratory muscle strength, pulmonary function, functional exercise capacity, quality of life, and physical activity in healthy older adults in the community. Due to limitations in manpower and resources, a convenience sampling method will be used, and participants will be recruited from 6-8 community centers, with cluster randomization at the community level. Each community center is expected to recruit 10-15 participants, with a total of 80 participants. The experimental group will use a handheld threshold trainer (n = 40, starting at 40% of Maximum Inspiratory Pressure, MIP), while the control group will use an inducible spirometer (n = 40, with the goal of raising one or more balls to the top). This study will explore the differences and potential of these two training methods in improving respiratory muscle strength, daily living abilities, exercise performance, and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥65 years.
  • Normal cognitive function
  • No psychiatric disorders or Alzheimer's disease.
  • Able to go out independently and perform self-care.
  • Willing and able to participate throughout the health-promotion program.

排除标准

  • Individuals whom a physician has determined have a serious illness for which exercise is not recommended.
  • Individuals with functional limitations that may interfere with inspiratory muscle training (IMT) and/or maximal inspiratory pressure (MIP) measurement-for example, unstable angina, complex arrhythmias, rheumatologic disease, active infectious disease, or cognitive impairment.

结局指标

主要结局

Respiratory Muscle Strength

时间窗: Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end)

Respiratory muscle strength will be measured with the GiO™ device for maximal inspiratory and expiratory pressure, yielding maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Three trials will be performed; the best value will be recorded and expressed in cmH₂O.

次要结局

  • Berg Balance Scale (BBS)(Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).)
  • Pulmonary Function(Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).)
  • Quality of Life and Confidence in Physical Exertion(Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end))
  • 30-Second Chair Stand Test(Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end))
  • Get Up and Go Test(Baseline (≤7 days before intervention start) and post-intervention (≤7 days after intervention end).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chung-Shan Hung

Assistant Professor

Hungkuang University

研究点 (1)

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