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Completed

NCT Number: NCT04890275

Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

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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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Hallam University

Sheffield, South Yorkshire, s10 2BP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Rates

    Time frame: 3 months

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

  2. Retention Rates

    Time frame: 3 months

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

  3. Acceptability of allocation

    Time frame: 3 months

    will be assessed by attrition rates, comparing participant withdrawal between experimental and control groups and reasons for dropout where appropriate.

  4. Acceptability of the exercise study

    Time frame: 3 months

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

  5. Completion Rates

    Time frame: 3 months

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

Secondary outcomes

  1. Change in PAD severity

    Time frame: 3 months

    ankle-brachial pressure index

  2. Change in muscle size

    Time frame: 3 months

    Size of vastus lateralis measured via ultrasound

  3. Change in strength

    Time frame: 3 months

    Unilateral isometric maximal voluntary contraction

  4. Change in walk ability

    Time frame: 3 months

    Measured via the 6-minute walk test

  5. Change in physical function

    Time frame: 3 months

    Measured via timed up-and-go test

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 18, 2021
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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