Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: Blood flow restricted resistance exercise (BFR); Other: Resistance exercise without blood flow restricted (NON-BFR)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2BP
      • Sheffield Hallam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BFR; Participants will participate in a supervised low load lower body blood flow restriction resistance exercise program twice a week for 12 weeks	Other: 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.
ACTIVE_COMPARATOR: 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)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rates	Defined as rate of invited participants who are eligible and consenting.	3 months
Retention Rates	Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.	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.	3 months
Acceptability of the exercise study	Will be evaluated by participants feedback via one-to-one semi-structured interviews.	3 months
Completion Rates	Completion is determined by participants that attend baseline testing and post exercise intervention testing.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PAD severity	ankle-brachial pressure index	3 months
Change in muscle size	Size of vastus lateralis measured via ultrasound	3 months
Change in strength	Unilateral isometric maximal voluntary contraction	3 months
Change in walk ability	Measured via the 6-minute walk test	3 months
Change in physical function	Measured via timed up-and-go test	3 months

Collaborators and Investigators

• Sponsor: Sheffield Hallam University
• Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 21, 2021
• Primary Completion (ACTUAL): March 5, 2022
• Study Completion (ACTUAL): April 30, 2022

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (ACTUAL): May 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Feasability; Blood flow restricted resistance exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: ER15905458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No