Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

Study Overview
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Brief Summary
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A randomised controlled trial evaluating the feasibility and acceptability of a 12 week lower body blood flow restricted resistance exercise programme for people with peripheral arterial disease.

Detailed Description
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The primary aim of this study is to determine the feasibility of 12 weeks of lower body resistance exercise performed with blood flow restriction (BFR) in people with peripheral arterial disease. Resistance exercise with BFR involves placing inflatable cuffs proximal to the exercise limbs in order to manipulate blood flow and enhance the training response. Secondary aim of this study is to evaluate changes in ABPI, muscle size, strength and physical function at mid-and post- intervention.

Official Title
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Blood Flow Restricted Resistance Training in Peripheral Arterial Disease: a Randomised Controlled Trial Feasibility Study

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: Blood flow restricted resistance exercise (BFR)
* Other: Resistance exercise without blood flow restricted (NON-BFR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with PAD 6 months post diagnosis. Ankle-brachial pressure index <0.9. People physically able to perform leg press and leg extension resistance exercise. Exclusion Criteria: Ankle-brachial pressure index >0.89. People unable to visit the laboratory twice weekly for exercise sessions. People unable to do leg press and leg extension exercise. People whose walking is limited by a non-PAD condition. People with PAD with critical limb ischemia (including symptoms of pain at rest and skin ulcers). People with Dementia. People who have had major surgery or myocardial infarction within the past 6 months. Previous stroke. Previous thrombosis. People who have major surgery scheduled during the intervention period.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFR<br>Participants will participate in a supervised low load lower body blood flow restriction resistance exercise program twice a week for 12 weeks | Other: Blood flow restricted resistance exercise (BFR)<br>* Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg inflated to 50% limb occlusion following standard BFR guidelines. Participants will then perform leg press including 1 set of 30 reps, then 3 sets of 15 reps at 20% 1RM. Rest for 5 minutes without cuff inflation. Cuffs will be re inflated and participants will perform knee extension including 3 x 15 repetitions at 20% 1RM.<br>|
| Active Comparator: NON-BFR<br>Participants will participate in a supervised low load lower resistance exercise program twice a week for 12 weeks (matched training volume as experimental arm but without BFR) | Other: Resistance exercise without blood flow restricted (NON-BFR)<br>* Participants will follow the same exercise protocol as the blood flow restriction group but with out BFR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rates | Defined as rate of invited participants who are eligible and consenting. | 3 months | 
| Retention Rates | Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions. | 3 months | 
| Acceptability of allocation | will be assessed by attrition rates, comparing participant withdrawal between experimental and control groups and reasons for dropout where appropriate. | 3 months | 
| Acceptability of the exercise study | Will be evaluated by participants feedback via one-to-one semi-structured interviews. | 3 months | 
| Completion Rates | Completion is determined by participants that attend baseline testing and post exercise intervention testing. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PAD severity | ankle-brachial pressure index | 3 months | 
| Change in muscle size | Size of vastus lateralis measured via ultrasound | 3 months | 
| Change in strength | Unilateral isometric maximal voluntary contraction | 3 months | 
| Change in walk ability | Measured via the 6-minute walk test | 3 months | 
| Change in physical function | Measured via timed up-and-go test | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood flow restricted resistance exercise, Feasability