Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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)
盲法说明
We will implement a double-masking protocol, ensuring that participants and outcome assessors are all blinded to group assignments. Additionally, group assignments will also be masked from the data analyzer to minimize potential bias.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •(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.
研究组 & 干预措施
Intervention group
Participants in the experimental group will receive a 6 week combined BFR and IMT intervention
干预措施: Exercise (Behavioral)
Control group
Participants in the control group will receive a 6-week combined combined BFR and sham IMT intervention.
干预措施: Sham Control (Behavioral)
研究者
Pei-Shan, Tsai
Professor
Taipei Medical University