Blood Flow Restriction on Functional Mobility in Pre-frail Older Adults

Study Overview
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Brief Summary
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This study investigates the effect of blood flow restriction with resistance exercise on functional mobility in pre-frail older adults. It is hypothesized that receiving resistance exercise with blood flow restriction will exhibit better improvement on functional mobility than only receiving resistance exercise in pre-frail older adults.

Detailed Description
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Participants aged over 65 years old with less than two items positive of Fried frailty phenotype assessment result will be recruited. The participants will be randomly assigned to two training groups, blood flow restriction resistance exercise and traditional resistance exercise. Both groups will receive the training 30 minutes/session, two sessions/week for six weeks. Muscle strength of the lower extremities and functional mobility tests will be used to assess outcomes at pre-training, 3-week after training, post-training, and one-month and two-month follow-up.

Official Title
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Effect of Blood Flow Restriction Resistance Exercise on Functional Mobility in Pre-Frail Older Adults

Conditions
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Frailty

Intervention / Treatment
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* Other: Resistance exercise on the lower extremities
* Other: Resistance exercise on the lower extremities with blood flow restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 65 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: 65 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: Experimental<br>Resistance exercise with blood flow restriction | Other: Resistance exercise on the lower extremities with blood flow restriction<br>* Blood flow restriction on the thigh of the dominant leg will be used in combination with resistance exercise.<br>|
| Active Comparator: Control<br>Traditional resistance exercise | Other: Resistance exercise on the lower extremities<br>* Resistance exercise mainly on the lower extremities will be executed by carrying weight according to each participant's tolerance while performing certain movements, such as side step-up, sit-to-stand, and tip-toe-standing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Timed-Up and Go (TUG) test | Timed-Up and Go test | Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention | 
| Change of 30 seconds sit to stand | 30 seconds sit to stand test | Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention | 
| Change of muscle strength of the lower extremities | Muscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors | Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of one-repetition maximum | One-repetiton maximum of side step-ups | Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention | 
| Change of muscle mass | Muscle mass of the upper and lower extremities and trunk | Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention | 
| Change of hand grip strength | Bilateral grip strength | Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-frail, blood flow restriction, functional mobility