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| Name | Class |
|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BFR | Experimental | 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 | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Hallam University | Sheffield | South Yorkshire | s10 2BP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37819259 | Derived | 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. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| 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. |
|
| 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 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |