Peripheral Arterial DiseaseNCT04890275
Blood Flow Restricted Resistance Training in Peripheral Arterial Disease
A study testing Blood flow restricted resistance exercise (BFR) and Resistance exercise without blood flow restricted (NON-BFR) in people with Peripheral Arterial Disease, run by Sheffield Hallam University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Blood flow restricted resistance exercise (BFR) and Resistance exercise without blood flow restricted (NON-BFR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallam University
Sheffield, South Yorkshire, s10 2BP
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Blood flow restricted resistance exercise (BFR), Resistance exercise without blood flow restricted (NON-BFR)
- Keywords
- Blood flow restricted resistance exercise, Feasability
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| BFR | Experimental | Participants will participate in a supervised low load lower body blood flow restriction resistance exercise program twice a week for 12 weeks Receives: 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) Receives: Other: Resistance exercise without blood flow restricted (NON-BFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rates
Defined as rate of invited participants who are eligible and consenting.
Measured: 3 months
Retention Rates
Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.
Measured: 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.
Measured: 3 months
Acceptability of the exercise study
Will be evaluated by participants feedback via one-to-one semi-structured interviews.
Measured: 3 months
Completion Rates
Completion is determined by participants that attend baseline testing and post exercise intervention testing.
Measured: 3 months
Secondary outcomes (5)
Change in PAD severity
ankle-brachial pressure index
Measured: 3 months
Change in muscle size
Size of vastus lateralis measured via ultrasound
Measured: 3 months
Change in strength
Unilateral isometric maximal voluntary contraction
Measured: 3 months
Change in walk ability
Measured via the 6-minute walk test
Measured: 3 months
Change in physical function
Measured via timed up-and-go test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start21 Apr 2021
- Primary completion5 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890275
- Sponsor's protocol ID
- ER15905458
- Status last verified
- Nov 2022
- First submitted
- 4 Mar 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37819259
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restricted Resistance Training in Peripheral Arterial Disease: a Randomised Controlled Trial Feasibility Study
- ClinicalTrials.gov ID
- NCT04890275
- Acronym / sponsor ID
- ER15905458
- Conditions
- Peripheral Arterial Disease
- Keywords
- Blood flow restricted resistance exercise, Feasability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 5 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR | Experimental | Other: 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 | Active comparator | Other: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | BFR |
| 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. | Other | NON-BFR |
Primary outcome
Recruitment Rates
Time frame: 3 months
Defined as rate of invited participants who are eligible and consenting.
Retention Rates
Time frame: 3 months
Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.
Acceptability of allocation
Time frame: 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
Time frame: 3 months
Will be evaluated by participants feedback via one-to-one semi-structured interviews.
Completion Rates
Time frame: 3 months
Completion is determined by participants that attend baseline testing and post exercise intervention testing.
5 secondary outcomes
Change in PAD severity
Time frame: 3 months
Change in muscle size
Time frame: 3 months
Change in strength
Time frame: 3 months
Change in walk ability
Time frame: 3 months
Change in physical function
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 37819259Parkington 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restricted resistance exercise (BFR) and Resistance exercise without blood flow restricted (NON-BFR) in people with Peripheral Arterial Disease, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04890275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.