Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

Sheffield Hallam University

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Other: Resistance exercise without blood flow restricted (NON-BFR); Other: Blood flow restricted resistance exercise (BFR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04890275

ER15905458

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

BFR

Experimental group

Description:

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

Treatment:

Other: Blood flow restricted resistance exercise (BFR)

NON-BFR

Active Comparator group

Description:

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)

Treatment:

Other: Resistance exercise without blood flow restricted (NON-BFR)