Blood Flow Restriction Training in Pre-frail and Frail Older Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Frailty

Intervention / Treatment
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* Other: Blood flow restriction resistance training
* Other: Resistance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 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: Blood flow restriction resistance training<br> | Other: Blood flow restriction resistance training<br>* The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.<br>|
| Active Comparator: Resistance training<br> | Other: Resistance training<br>* The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscle strength of the lower extremities | Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors | Before training, 3 and 6 weeks after training, and one and two months follow-ups | 
| Change of 30 seconds sit to stand | 30 seconds sit to stand | Before training, 3 and 6 weeks after training, and one and two months follow-ups | 
| Change of timed-up-and-go test | Timed-up-and-go test | Before training, 3 and 6 weeks after training, and one and two months follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of one-repetition maximum | One-repetition maximum of step-ups | Before training, 3 and 6 weeks after training, and one and two months follow-ups | 
| Change of muscle mass | Muscle mass of the upper and lower extremities and trunk | Before training, 3 and 6 weeks after training, and one and two months follow-ups | 
| Change of hand grip | Bilateral hand grip strength | Before training, 3 and 6 weeks after training, and one and two months follow-ups | 
| Change of physical activity level | The International Physical Activity Questionnaire (IPAQ) | Before training, 3 and 6 weeks after training, and one and two months follow-ups | 

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