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Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults

2026年8月19日更新者：Pei-Shan, Tsai、Taipei Medical University

Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults: A Pilot Randomized Controlled Trial

This randomized controlled trial study aims to evaluate the feasibility and preliminary efficacy of a combined inspiratory muscle training (IMT) and blood flow restriction (BFR) intervention in frail older adults. Outcomes of interest include feasibility, physical function, respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a parallel randomized controlled trial. 30 participants who are older adults with frailty will be enrolled.

Eligible participants who complete the baseline measurements will be randomly allocated to a combined BFR and IMT intervention group (N=15) or in the control group with BFR and sham IMT (N=15).

Primary outcomes include feasibility and physical function (i.e., the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), and Time Up and Go (TUG) test). Secondary outcomes include respiratory muscle strength, handgrip strength, five-times sit-to-stand performance, body composition, frailty level, fall efficacy, blood pressure, and adverse events. All outcomes will be assessed at baseline (T0) and immediately after the 6-week intervention period (T1) in both groups.

研究类型

介入性

注册 (估计的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Pei-Shan Tsai Professor, PhD
电话号码：6321 +886227361661
邮箱：ptsai@tmu.edu.tw

学习地点

台湾
- - Taipei、台湾、11031
    - Taipei Medical University
    - 接触：
      
      Pei-Shan Tsai Professor, PhD
      
      电话号码：6321 +886227361661
      
      邮箱：ptsai@tmu.edu.tw

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Community-dwelling adults aged 65 years and older who are classified as at least "vulnerable" using the Clinical Frailty Scale (score ≥4).
Participants must have no cognitive impairment and be able to follow commands, as assessed by the Mini-Mental State Examination (MMSE).

Exclusion Criteria:

(1) are unable to participate in exercise (e.g., due to severe musculoskeletal disorders)
(2) have high-risk factors for exercise, such as uncontrolled hypertension (>150 mmHg systolic blood pressure (SBP) / >90 mmHg diastolic blood pressure (DBP), coagulation disorders, and deep venous thrombosis
(3) have hematological disorders or are using hematology related-medications
(4) have significant comorbidities, including a history of stroke, diabetes with severe complications, or cardiovascular diseases
(5) chronic lung conditions (e.g., obstructive pulmonary disease, asthma), and
(6) have participated in a structured exercise training program within the past 3 months at a frequency exceeding three sessions per week.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Intervention group Participants in the experimental group will receive a 6 week combined BFR and IMT intervention	行为的：Exercise Each session will last approximately 60 minutes and will include three components: (1) an initial 3-minute IMT exercise performed at an intensity corresponding to rating of perceived exertion (RPE) 11-13 on the Borg 6-20 scale, (2) a 50-minute low-intensity exercise program combined with BFR, and (3) a second 3-minute IMT session at the same target intensity. For the IMT, the protocol follows a progressive intensity model, starting with 30% of the maximum inspiratory pressure (MIP) in Week 1 to allow participants to become familiar with the technique. The intensity will gradually increase to a target of 60% MIP by Week 6, based on the participants' tolerance. For the BFR, during weeks 1-2, participants will train at constant loads. From weeks 2-6, training loads will be increased. Cuff pressure will be prescribed relative to the calculated arterial occlusion pressure (AOP): 50% in weeks 1-2, 60% in weeks 3-4, and 70% in weeks 5-6 for both lower- and upper-body exercises.
假比较器：Control group Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.	行为的：Sham Control Participants in the control group will perform the identical BFR exercise protocol as the intervention group. However, IMT will be delivered at 2% of MIP, which is considered a sham condition and has not been shown to improve respiratory muscle function

参与者组/臂

干预/治疗

实验性的：Intervention group

Participants in the experimental group will receive a 6 week combined BFR and IMT intervention

行为的：Exercise

Each session will last approximately 60 minutes and will include three components: (1) an initial 3-minute IMT exercise performed at an intensity corresponding to rating of perceived exertion (RPE) 11-13 on the Borg 6-20 scale, (2) a 50-minute low-intensity exercise program combined with BFR, and (3) a second 3-minute IMT session at the same target intensity.

For the IMT, the protocol follows a progressive intensity model, starting with 30% of the maximum inspiratory pressure (MIP) in Week 1 to allow participants to become familiar with the technique. The intensity will gradually increase to a target of 60% MIP by Week 6, based on the participants' tolerance.

For the BFR, during weeks 1-2, participants will train at constant loads. From weeks 2-6, training loads will be increased. Cuff pressure will be prescribed relative to the calculated arterial occlusion pressure (AOP): 50% in weeks 1-2, 60% in weeks 3-4, and 70% in weeks 5-6 for both lower- and upper-body exercises.

假比较器：Control group

Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.

行为的：Sham Control

Participants in the control group will perform the identical BFR exercise protocol as the intervention group. However, IMT will be delivered at 2% of MIP, which is considered a sham condition and has not been shown to improve respiratory muscle function

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Recruitment rate 大体时间：T0 = baseline; T1 = immediately after intervention	The recruitment rate will be calculated by dividing the number of recruited participants by the number of eligible participants	T0 = baseline; T1 = immediately after intervention
Attrition rate 大体时间：T0 = baseline; T1 = immediately after intervention	Attrition rate is the proportion of randomized participants who withdraw from the study or are lost to follow-up before completing the final assessment.	T0 = baseline; T1 = immediately after intervention
Exercise Enjoyment 大体时间：T0 = baseline; T1 = immediately after intervention	Enjoyment will be assessed using a single-item Exercise Enjoyment Scale, which asks participants, "How much did you enjoy the exercise session?). Responses are rated on a 7 Likert scale ranging from 1 (not at all) to 7 (extremely)	T0 = baseline; T1 = immediately after intervention
Short Physical Performance Battery (SPPB) 大体时间：T0 = baseline; T1 = immediately after intervention	The SPPB consists of three components-standing balance, gait speed, and repeated chair stands-each scored from 0 to 4 and summed to a total score ranging from 0 (worst performance) to 12 (best performance). Lower SPPB scores indicate poorer physical function and a higher risk of adverse outcomes, with scores below 10 predictive of all-cause mortality in older adults.	T0 = baseline; T1 = immediately after intervention
6-Minute Walk Test (6MWT) 大体时间：T0 = baseline; T1 = immediately after intervention	The 6MWT will be used to assess functional exercise capacity. Participants will be instructed to walk as far as possible along a flat, straight course for 6 minutes, and the total distance is recorded.	T0 = baseline; T1 = immediately after intervention
Time Up to Go (TUG) 大体时间：T0 = baseline; T1 = immediately after intervention	The TUG test is used to assess functional mobility, balance, and fall risk in older adults, incorporating a series of dynamic activities. Participants will be instructed to rise from a chair, walk three meters at a comfortable pace, turn around, walk back to the chair, and sit down. The total time taken to complete the task is recorded, with longer times indicating poorer functional mobility and higher fall risk	T0 = baseline; T1 = immediately after intervention

次要结果测量

结果测量	措施说明	大体时间
Respiratory Muscle Strength 大体时间：T0 = baseline; T1 = immediately after intervention	We will use the S-Index Test to evaluate the respiratory muscle function based on maximum dynamic inspiratory pressure, which is a recommended tool developed by POWERbreathe. Participants will be advised to avoid strenuous exercise for 24h and to rest in a sitting position for 15 minutes before the assessment. Then, they performed eight inspiratory maneuvers in a standing position, divided into three to four series of two to three repetitions.	T0 = baseline; T1 = immediately after intervention
Handgrip Strength 大体时间：T0 = baseline; T1 = immediately after intervention	Handgrip strength will be evaluated to estimate the maximum upper-limb muscle function in older adults. Participants will be seated with the shoulder adducted, the elbow flexed to 90°, and the forearm and wrist in a neutral position. They will then be instructed to squeeze the dynamometer as forcefully as possible.	T0 = baseline; T1 = immediately after intervention
Five-times sit-to-stand 大体时间：T0 = baseline; T1 = immediately after intervention	The five-times sit-to-stand test is simple to administer and has been widely applied in both clinical and research settings. Participants will sit with their backs against the chair and be instructed to stand and sit five times as quickly as possible.	T0 = baseline; T1 = immediately after intervention
Frailty level 大体时间：T0 = baseline; T1 = immediately after intervention	The Clinical Frailty Scale (CFS) is a 9-point global clinical measure ranging from 1 (very fit) to 9 (terminally ill), used to classify frailty severity in older adults. A traditional Chinese version of the CFS has been validated in Taiwanese older adults, demonstrating acceptable inter-rater reliability and good criterion validity against established frailty measures	T0 = baseline; T1 = immediately after intervention
Fall Efficacy 大体时间：T0 = baseline; T1 = immediately after intervention	The short form of the Falls Efficacy Scale-International (FES-I) includes 7 items rated on a 4-point Likert scale from 1 (not at all concerned) to 4 (very concerned). The total score ranges from 7 to 28, with higher values indicating greater concern about falling	T0 = baseline; T1 = immediately after intervention
Adverse events 大体时间：T0 = baseline; T1 = immediately after intervention	The study team will record adverse events during the intervention caused by the exercise, including falls, fractures, exercise-related pain, dizziness, muscle strain, sprains, respiratory and cardiac adverse events, and hospitalization.	T0 = baseline; T1 = immediately after intervention
Fat mass 大体时间：T0 = baseline; T1 = immediately after intervention	Fat mass will be assessed using a body composition analyzer and recorded in kilograms	T0 = baseline; T1 = immediately after intervention
Fat-free mass 大体时间：T0 = baseline; T1 = immediately after intervention	Fat-free mass will be assessed using a body composition analyzer and recorded in kilograms.	T0 = baseline; T1 = immediately after intervention

其他结果措施

结果测量	措施说明	大体时间
The Borg Rating of Perceived Exertion (RPE) Scale 大体时间：T0 = baseline; T1 = immediately after intervention	The Borg RPE scale reflects an individual's subjective perception of exercise intensity, integrating sensations of physical effort, breathlessness, and fatigue. The scale ranges from 6 to 20, where 6 indicates "no exertion at all" and 20 indicates "maximal exertion." This RPE score will be assessed every training session	T0 = baseline; T1 = immediately after intervention
Automated Office Blood Pressure 大体时间：T0 = baseline; T1 = immediately after intervention	Automated Office Blood Pressure will be monitored before and after intervention to minimize cardiovascular risks and ensure that timely medical assistance is available for participants who experience any discomfort. Upon arrival at the lab, participants will be asked to sit for at least 5 minutes before the first blood pressure reading; the average of two readings will be used for that visit	T0 = baseline; T1 = immediately after intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Taipei Medical University

合作者

National Taiwan University

The University of Texas at Austin

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月30日

初级完成 (估计的)

2027年7月31日

研究完成 (估计的)

2027年7月31日

研究注册日期

首次提交

2026年4月23日

首先提交符合 QC 标准的

2026年5月1日

首次发布 (实际的)

2026年5月7日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults