NCT04890275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

March 4, 2021

Last Update Submit

November 7, 2022

Conditions

Peripheral Arterial Disease

Keywords

Blood flow restricted resistance exerciseFeasability

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Change in PAD severity

    3 months

  • Change in muscle size

    3 months

  • Change in strength

    3 months

  • Change in walk ability

    3 months

  • Change in physical function

    3 months

Study Arms (2)

BFR

EXPERIMENTAL

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)

NON-BFR

ACTIVE COMPARATOR

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)

Interventions

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.

BFR
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.

NON-BFR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Hallam University

Sheffield, South Yorkshire, s10 2BP, United Kingdom

Location

Related Publications (1)

  • Parkington T, Broom D, Maden-Wilkinson T, Nawaz S, Klonizakis M. Low-intensity resistance exercise with blood flow restriction for patients with claudication: A randomized controlled feasibility trial. Vasc Med. 2023 Dec;28(6):554-563. doi: 10.1177/1358863X231200250. Epub 2023 Oct 11.

    PMID: 37819259DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

May 18, 2021

Study Start

April 21, 2021

Primary Completion

March 5, 2022

Study Completion

April 30, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)