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| Name | Class |
|---|---|
| University Hospitals Coventry and Warwickshire NHS Trust | OTHER |
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The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication.
30 participants with PAD will be randomised to one of two groups: either exercise or usual care. The 12 week exercise intervention will consist of a home-based circuit programme, including both resistance exercises and walking. This will be combined with promoting free-living walking throughout the rest of the week. Exercise will be regulated via the use of a wearable activity monitor. Biweekly phone calls will address compliance with the intervention. The primary outcomes are feasibility and acceptability, which will be determined after 12 weeks via recruitment and attrition rates, protocol adherence and with participant interviews. Secondary outcomes include changes in pain-free and maximal walking distances with both a graded treadmill test and six-minute walk test, hand grip strength, physical activity behaviour (measured with an accelerometer), quality of life (measured with the SF-36, VascuQol and E5-5D-5L questionnaires) after 12 and 24 weeks. Investigators will also assess changes in markers of inflammation, vascular remodeling, mitochondrial biogenesis and oxidative stress at 12 and 24 weeks. Other outcomes include changes in time spent resting during a six-minute walk test and time to pain cessation following a graded treadmill test at 12 and 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | Home-based circuit and community walking exercise |
|
| Usual care | No Intervention | Usual activity/healthcare |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise group | Behavioral | The exercise group will receive a 12-week home-based exercise programme, with a wearable activity watch to regulate physical activity behaviour. This group will also receive biweekly telephone calls from the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention feasibility assessed via recruitment rate | The investigators will record the number of eligible participants, as well as the number who enroll onto the study. | Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion) |
| Intervention feasibility assessed via attrition rate | The investigators will record the number of protocol discontinuations and losses to follow-up. | Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion) |
| Intervention feasibility assessed via protocol adherence | The investigators will examine discrepancies between intervention prescription and what is completed. | Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion) |
| Intervention acceptability via participant interviews | One-to-one interviews will be held between an investigator and participant who has either completed the intervention, withdrawn or declined participation, to ask questions regarding the intervention protocol. | Will be evaluated after the intervention period (either at 12 week or 24 week follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| 12 and 24 week change in six-minute walk distance and pain-free walk distance | Change in six-minute and pain-free walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. | Baseline to 12 weeks and 24 weeks |
| 12 and 24 week change in pain-free and maximal treadmill walk distance |
| Measure | Description | Time Frame |
|---|---|---|
| 12 and 24 week change in rest times during a six-minute walk test | Change in time spent resting during a six-minute walk test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. | Baseline to 12 weeks and 24 weeks |
| 12 and 24 week change in pain cessation following a treadmill test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Waddell, MSc | Coventry University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coventry University | Coventry | West Midlands | CV1 2DS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39645388 | Derived | Waddell A, Denton F, Powell R, Broom DR, Birkett ST, McGregor G, Harwood AE. "It's put a routine and regimen in my life" - Participant experiences with a programme of community walking and home-based circuit training for intermittent claudication. J Vasc Nurs. 2024 Dec;42(4):276-281. doi: 10.1016/j.jvn.2024.09.003. Epub 2024 Sep 28. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Change in pain-free and maximal treadmill walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
| Baseline to 12 weeks and 24 weeks |
| 12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer) | Change in left and right hand grip strength after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. | Baseline to 12 weeks and 24 weeks |
| 12 and 24 week change in physical activity measured by accelerometer data | Change in physical activity behaviour at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group, using accelerometer data. | Baseline to 12 weeks and 24 weeks |
| 12 and 24 week change in SF-36 score | Change in 36 Item Short Form survey scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 0-100, with higher scores associated with a better outcome). | Baseline to 12 weeks and 24 weeks |
| 12 and 24 week change in VascuQol questionnaire score | Change in Vascular Quality of Life questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 1-7, with higher scores associated with a better outcome). | Baseline to 12 weeks and 24 weeks |
| 12 and 24 week change in EQ-5D-5L questionnaire score | Change in European Quality of Life Five Dimension questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Scores range from 1-5, with lower scores associated with a better outcome). | Baseline to 12 weeks and 24 weeks |
| 12 and 24 week change in circulating markers of inflammation | Investigators will compare blood sample measures of IL-6, TNF-α, CRP between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks. | Baseline to 12 weeks and 24 weeks |
| 12 and 24 week change in circulating markers of vascular remodelling | Investigators will compare blood sample measures of VEGF between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks. | Baseline to 12 weeks and 24 weeks |
Change in time to pain cessation following a treadmill test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
| Baseline to 12 weeks and 24 weeks |
| 12 and 24 week changes in walking speed during a six-minute walk test | Change in walking speed during a six-minute walk test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. | Baseline to 12 weeks and 24 weeks |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |