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临床试验/NCT04507152
NCT04507152已完成不适用

Effect of Blood Flow Restriction Resistance Training on Muscle Strength and Functional Performance in Frail Older Adults

National Cheng Kung University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Change of 30 seconds sit to stand

研究概览

简要总结

Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Intervention such as exercise, especially resistance exercise, has proven to be effective to improve frail condition in the elderly in the previous literature. However, blood flow restriction (BFR) training, a new resistance exercise training method, need merely lower resistance power and shorter training duration compared with traditional resistance exercise. Previous researches also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this study will test the effect of BFR training on muscle strength and functional performance in pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score between 3 to 5 will be recruited. Participants will be assigned to two groups using randomized block design with BFR training and control group. Structured questionnaire and physical function measurement will be used to assess the pre-intervention condition and outcome of different interventions. The participants will be assessed before training (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up at one and three months after training. Physical function measurement will include hand grip, muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and timed up and go test. Two-way repeated measures analysis of variance will be used to test the pre-test, 3-week, post-test and follow-ups difference between the two 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
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged over 60 years old
  • Fried frailty index fulfill 1-2 criteria
  • Able to walk 6 meters independently
  • Able to understand and follow ≥ 3 instructions

排除标准

  • Severe hypertension (>180/110mmHg)
  • Peripheral neuropathy
  • History of deep-vein thrombosis (DVT)
  • Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial infarction, pulmonary hypertension, coronary artery stenosis)
  • Neuromuscular diseases (i.e. Stroke, Parkinsons' disease)
  • History of resisted exercise training program within the last 6 months before screening

结局指标

主要结局

Change of 30 seconds sit to stand

时间窗: Before training, 3 and 6 weeks after training, and one and two months follow-ups

30 seconds sit to stand

Change of timed-up-and-go test

时间窗: Before training, 3 and 6 weeks after training, and one and two months follow-ups

Timed-up-and-go test

Change of muscle strength of the lower extremities

时间窗: Before training, 3 and 6 weeks after training, and one and two months follow-ups

Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors

次要结局

  • Change of muscle mass(Before training, 3 and 6 weeks after training, and one and two months follow-ups)
  • Change of hand grip(Before training, 3 and 6 weeks after training, and one and two months follow-ups)
  • Change of one-repetition maximum(Before training, 3 and 6 weeks after training, and one and two months follow-ups)
  • Change of physical activity level(Before training, 3 and 6 weeks after training, and one and two months follow-ups)

研究者

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

Pei-Yun Lee

Assistant professor

National Cheng Kung University

研究点 (1)

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