Home-based Circuit Training for People With Intermittent Claudication

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community WALKing and Home-baSed circuiT tRaining in peOple liviNG With Intermittent Claudication (WALK-STRONG): a Randomised Controlled Feasibility Trial

Conditions
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Peripheral Artery Disease, Intermittent Claudication

Intervention / Treatment
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* Behavioral: Exercise group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ankle/brachial index (ABPI) < 0.9 at rest or a drop of 20mmHg after exercise testing Ability to walk independently English speaking Able to follow instructions ≥ 18 years of age Exclusion Criteria: Unable to provide informed consent Walking impairment for a reason that is not PAD Critical limb ischaemia Asymptomatic PAD Active cancer treatment Severe mental or physical limitations precluding participation safely in the home environment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Home-based circuit and community walking exercise | Behavioral: Exercise group<br>* 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.<br>|
| No Intervention: Usual care<br>Usual activity/healthcare | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home-based exercise, circuit training, walking