Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2022-04-30

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.

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BFR

Participants will participate in a supervised low load lower body blood flow restriction resistance exercise program twice a week for 12 weeks

Group Type EXPERIMENTAL

Blood flow restricted resistance exercise (BFR)

Intervention Type OTHER

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.

NON-BFR

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)

Group Type ACTIVE_COMPARATOR

Resistance exercise without blood flow restricted (NON-BFR)

Intervention Type OTHER

Participants will follow the same exercise protocol as the blood flow restriction group but with out BFR.

Interventions

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Blood flow restricted resistance exercise (BFR)

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.

Intervention Type OTHER

Resistance exercise without blood flow restricted (NON-BFR)

Participants will follow the same exercise protocol as the blood flow restriction group but with out BFR.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No