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Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Blood flow restricted resistance exercise (BFR)
Resistance exercise without blood flow restricted (NON-BFR)
Sponsored by
Sheffield Hallam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Blood flow restricted resistance exercise, Feasability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sheffield Hallam University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BFR

NON-BFR

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2021
Last Updated
November 7, 2022
Sponsor
Sheffield Hallam University
Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04890275
Brief Title
Blood Flow Restricted Resistance Training in Peripheral Arterial Disease
Official Title
Blood Flow Restricted Resistance Training in Peripheral Arterial Disease: a Randomised Controlled Trial Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
March 5, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Hallam University
Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Blood flow restricted resistance exercise, Feasability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BFR
Arm Type
Experimental
Arm Description
Participants will participate in a supervised low load lower body blood flow restriction resistance exercise program twice a week for 12 weeks
Arm Title
NON-BFR
Arm Type
Active Comparator
Arm 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)
Intervention Type
Other
Intervention Name(s)
Blood flow restricted resistance exercise (BFR)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance exercise without blood flow restricted (NON-BFR)
Intervention Description
Participants will follow the same exercise protocol as the blood flow restriction group but with out BFR.
Primary Outcome Measure Information:
Title
Recruitment Rates
Description
Defined as rate of invited participants who are eligible and consenting.
Time Frame
3 months
Title
Retention Rates
Description
Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.
Time Frame
3 months
Title
Acceptability of allocation
Description
will be assessed by attrition rates, comparing participant withdrawal between experimental and control groups and reasons for dropout where appropriate.
Time Frame
3 months
Title
Acceptability of the exercise study
Description
Will be evaluated by participants feedback via one-to-one semi-structured interviews.
Time Frame
3 months
Title
Completion Rates
Description
Completion is determined by participants that attend baseline testing and post exercise intervention testing.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in PAD severity
Description
ankle-brachial pressure index
Time Frame
3 months
Title
Change in muscle size
Description
Size of vastus lateralis measured via ultrasound
Time Frame
3 months
Title
Change in strength
Description
Unilateral isometric maximal voluntary contraction
Time Frame
3 months
Title
Change in walk ability
Description
Measured via the 6-minute walk test
Time Frame
3 months
Title
Change in physical function
Description
Measured via timed up-and-go test
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sheffield Hallam University
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
s10 2BP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

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