Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

Sheffield Hallam University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Blood flow restricted resistance exercise (BFR)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.

Resistance exercise without blood flow restricted (NON-BFR)OTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Outcomes

Primary Outcomes

Recruitment Rates

Defined as rate of invited participants who are eligible and consenting.

Time frame: 3 months

Retention Rates

Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.

Time frame: 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.

Time frame: 3 months

Acceptability of the exercise study

Will be evaluated by participants feedback via one-to-one semi-structured interviews.

Time frame: 3 months

Completion Rates

Completion is determined by participants that attend baseline testing and post exercise intervention testing.

Time frame: 3 months

Secondary Outcomes

Change in PAD severity

ankle-brachial pressure index

Time frame: 3 months

Change in muscle size

Size of vastus lateralis measured via ultrasound

Time frame: 3 months

Change in strength

Unilateral isometric maximal voluntary contraction

Time frame: 3 months

Data from ClinicalTrials.gov

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