Blood Flow Restricted Resistance Training in Peripheral Arterial Disease
- Conditions
- Peripheral Arterial Disease
- Interventions
- Other: Blood flow restricted resistance exercise (BFR)Other: Resistance exercise without blood flow restricted (NON-BFR)
- Registration Number
- NCT04890275
- Lead Sponsor
- Sheffield Hallam University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BFR Blood flow restricted resistance exercise (BFR) Participants will participate in a supervised low load lower body blood flow restriction resistance exercise program twice a week for 12 weeks NON-BFR Resistance exercise without blood flow restricted (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)
- Primary Outcome Measures
Name Time Method Recruitment Rates 3 months Defined as rate of invited participants who are eligible and consenting.
Retention Rates 3 months Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.
Acceptability of allocation 3 months will be assessed by attrition rates, comparing participant withdrawal between experimental and control groups and reasons for dropout where appropriate.
Acceptability of the exercise study 3 months Will be evaluated by participants feedback via one-to-one semi-structured interviews.
Completion Rates 3 months Completion is determined by participants that attend baseline testing and post exercise intervention testing.
- Secondary Outcome Measures
Name Time Method Change in walk ability 3 months Measured via the 6-minute walk test
Change in PAD severity 3 months ankle-brachial pressure index
Change in muscle size 3 months Size of vastus lateralis measured via ultrasound
Change in strength 3 months Unilateral isometric maximal voluntary contraction
Change in physical function 3 months Measured via timed up-and-go test
Trial Locations
- Locations (1)
Sheffield Hallam University
🇬🇧Sheffield, South Yorkshire, United Kingdom