Effect of Aerobic Exercise Combined With Blood Flow Restriction on Cardiopulmonary Function and Functional Activities in Frail Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 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
- 否
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.
研究组 & 干预措施
Control Group
干预措施: aerobic exercise (Other)
Experimental Group
干预措施: aerobic exercise combined with blood flow restriction (Other)
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
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
Walking speed
时间窗: At six weeks after completing the training
Test the gait speed under preferred and maximum speed walking
Lower extremity muscle strength
时间窗: Before training
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Lower extremity muscle strength
时间窗: After completing three-week training
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Lower extremity muscle strength
时间窗: After completing six-week training
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Lower extremity muscle strength
时间窗: At three weeks after completing the training
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Pulmonary function
时间窗: Before training
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Pulmonary function
时间窗: After completing three-week training
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Pulmonary function
时间窗: After completing six-week training
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Pulmonary function
时间窗: At three 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: Before 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
Timed up and go test
时间窗: After completing three-week training
This test measures the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Timed up and go test
时间窗: After completing six-week training
This test measures the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Timed up and go test
时间窗: At three 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
2 minutes step test
时间窗: Before training
Number of steps completed in 2 min
2 minutes step test
时间窗: After completing three-week training
Number of steps completed in 2 min
2 minutes step test
时间窗: After completing six-week training
Number of steps completed in 2 min
2 minutes step test
时间窗: At three weeks after completing the training
Number of steps completed in 2 min
6 minutes walking test
时间窗: Before training
Record the distance walked in 6 minutes
6 minutes walking test
时间窗: After completing three-week training
Record the distance walked in 6 minutes
6 minutes walking test
时间窗: After completing six-week training
Record the distance walked in 6 minutes
6 minutes walking test
时间窗: At three weeks after completing the training
Record the distance walked in 6 minutes
Walking speed
时间窗: Before training
Test the gait speed under preferred and maximum speed walking
Walking speed
时间窗: After completing three-week training
Test the gait speed under preferred and maximum speed walking
Walking speed
时间窗: After completing six-week training
Test the gait speed under preferred and maximum speed walking
Walking speed
时间窗: At three weeks after completing the training
Test the gait speed under preferred and maximum speed walking
次要结局
- Body composition(At six weeks after completing the training)
- Body composition(Before training)
- Body composition(After completing six-week training)
- Body composition(At three weeks after completing the training)
研究者
Pei-Yun Lee
Associate Professor
National Cheng Kung University