Blood Flow Restriction With Aerobic Exercise in Frail Older Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Rehabilitation

Intervention / Treatment
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* Other: aerobic exercise combined with blood flow restriction
* Other: aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br> | Other: aerobic exercise combined with blood flow restriction<br>* aerobic exercise combined with blood flow restriction for 18 sessions<br>|
| Active Comparator: Control Group<br> | Other: aerobic exercise<br>* aerobic exercise for 18 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity muscle strength | Use an hand-held dynamometer to measure bilateral lower limb muscle strength | Before training | 
| Lower extremity muscle strength | Use an hand-held dynamometer to measure bilateral lower limb muscle strength | After completing three-week training | 
| Lower extremity muscle strength | Use an hand-held dynamometer to measure bilateral lower limb muscle strength | After completing six-week training | 
| Lower extremity muscle strength | Use an hand-held dynamometer to measure bilateral lower limb muscle strength | At three weeks after completing the training | 
| Lower extremity muscle strength | Use an hand-held dynamometer to measure bilateral lower limb muscle strength | At six weeks after completing the training | 
| Pulmonary function | Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second | Before training | 
| Pulmonary function | Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second | After completing three-week training | 
| Pulmonary function | Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second | After completing six-week training | 
| Pulmonary function | Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second | At three weeks after completing the training | 
| Pulmonary function | Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second | At six weeks after completing the training | 
| Timed up and go test | 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 | Before training | 
| Timed up and go test | 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 | After completing three-week training | 
| Timed up and go test | 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 | After completing six-week training | 
| Timed up and go test | 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 | At three weeks after completing the training | 
| Timed up and go test | 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 | At six weeks after completing the training | 
| 2 minutes step test | Number of steps completed in 2 min | Before training | 
| 2 minutes step test | Number of steps completed in 2 min | After completing three-week training | 
| 2 minutes step test | Number of steps completed in 2 min | After completing six-week training | 
| 2 minutes step test | Number of steps completed in 2 min | At three weeks after completing the training | 
| 2 minutes step test | Number of steps completed in 2 min | At six weeks after completing the training | 
| 6 minutes walking test | Record the distance walked in 6 minutes | Before training | 
| 6 minutes walking test | Record the distance walked in 6 minutes | After completing three-week training | 
| 6 minutes walking test | Record the distance walked in 6 minutes | After completing six-week training | 
| 6 minutes walking test | Record the distance walked in 6 minutes | At three weeks after completing the training | 
| 6 minutes walking test | Record the distance walked in 6 minutes | At six weeks after completing the training | 
| Walking speed | Test the gait speed under preferred and maximum speed walking | Before training | 
| Walking speed | Test the gait speed under preferred and maximum speed walking | After completing three-week training | 
| Walking speed | Test the gait speed under preferred and maximum speed walking | After completing six-week training | 
| Walking speed | Test the gait speed under preferred and maximum speed walking | At three weeks after completing the training | 
| Walking speed | Test the gait speed under preferred and maximum speed walking | At six weeks after completing the training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities | Before training | 
| Body composition | Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities | After completing six-week training | 
| Body composition | Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities | At three weeks after completing the training | 
| Body composition | Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities | At six weeks after completing the training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood flow restriction, Aerobic exercise, Frailty, Elderly