Blood Flow Restricted Resistance Training in Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04890275
• Other study ID #: ER15905458
• Status: Completed
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: November 2022
• Source: Sheffield Hallam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2022
• Est. primary completion date: March 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Sheffield Hallam University	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Hallam University	Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rates	Defined as rate of invited participants who are eligible and consenting.	3 months
Primary	Retention Rates	Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.	3 months
Primary	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
Primary	Acceptability of the exercise study	Will be evaluated by participants feedback via one-to-one semi-structured interviews.	3 months
Primary	Completion Rates	Completion is determined by participants that attend baseline testing and post exercise intervention testing.	3 months
Secondary	Change in PAD severity	ankle-brachial pressure index	3 months
Secondary	Change in muscle size	Size of vastus lateralis measured via ultrasound	3 months
Secondary	Change in strength	Unilateral isometric maximal voluntary contraction	3 months
Secondary	Change in walk ability	Measured via the 6-minute walk test	3 months
Secondary	Change in physical function	Measured via timed up-and-go test	3 months