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临床试验/NCT06155227
NCT06155227尚未招募不适用

Effect of Aerobic Exercise Combined With Blood Flow Restriction on Cardiopulmonary Function and Functional Activities in Frail Older Adults

National Cheng Kung University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
Lower extremity muscle strength

研究概览

简要总结

Background:Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Exercise intervention including aerobic exercise training has been proven to be effective in improving aerobic capacity and frail condition in elderly. Recently a novel training method using blood flow restriction (BFR) combined with aerobic exercise has shown positive effects on muscles strength and physical function in healthy elderly. This training method only required lower exercise intensity compared with traditional aerobic exercise to observe improvement. However, it is still unclear whether aerobic exercise training combined with BFR could also improve aerobic capacity and physical function in frail older adults. Therefore, the aim of this study will be to investigate the effect of aerobic exercise combined with BFR on cardiopulmonary function and functional activities in frail older adults.

Method: This study will be an assessor-blind randomized controlled trial.Participants aged over 65 years old with more than one item positive of Fried frailty phenotype assessment results will be recruited from the hospital and nearby communities. The participants will be randomly assigned to one of two training groups, aerobic exercise with BFR and only aerobic exercise. The exercise will be executed 30 minutes/session, three sessions/week for six weeks. Cardiopulmonary function and performance of functional activities will be assessed at pre-training, 3 weeks after training, post-training, and 3- and 6-week follow-up.

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

入选标准

  • more than one positive item of Fried frailty phenotype assessment
  • able to walk more than 8 meters independently
  • can understand and follow more than three-step order

排除标准

  • severe hypertension (>160/100 mmHg)
  • cardiovascular disease, such as myocardial infarction, New York Heart Association class III or IV heart failure, pulmonary hypertension
  • deep vein thrombosis or peripheral vascular disease
  • peripheral neuropathy due to diabetes
  • neuromuscular diseases, such as stroke, Parkinson's disease, etc.

结局指标

主要结局

Lower extremity muscle strength

时间窗: At six weeks after completing the training

Use an hand-held dynamometer to measure bilateral lower limb muscle strength

Pulmonary function

时间窗: At six weeks after completing the training

Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second

Timed up and go test

时间窗: At six weeks after completing the training

This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down

Walking speed

时间窗: At six weeks after completing the training

Test the gait speed under preferred and maximum speed walking

2 minutes step test

时间窗: At six weeks after completing the training

Number of steps completed in 2 min

6 minutes walking test

时间窗: At six weeks after completing the training

Record the distance walked in 6 minutes

次要结局

  • Body composition(At six weeks after completing the training)

研究者

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

Pei-Yun Lee

Associate Professor

National Cheng Kung University

研究点 (2)

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