REmotely Supervised Exercise Therapy Trial 2

Study Overview
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Brief Summary
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Supervised exercise for intermittent claudication is a first line therapy for peripheral arterial disease, as recommended by the National Institute for Health and Clinical Excellence and the European Society for Vascular Surgery. However 2/3 of British trusts cannot implement this due to gym availability, costs, travel time and the requirement for social distancing. During the COVID-19 lockdown the investigators successfully performed a feasibility study for remotely supervised exercise using an electronic walking log and fortnightly video calls with a physiotherapist. RESET2 aims to compare the benefits of and adherence to remotely supervised exercise with self-directed exercise to absolute walking distance.

Detailed Description
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Design A single centre, pilot, randomised controlled trial at Mid and South Essex Hospitals Foundation Trust. The study is unfunded and sponsored by Mid and South Essex Hospitals National Health Service Trust. Sample size This is a pilot randomised controlled trial to generate a sample size calculation for a larger trial. Based on the feasibility data from RESET1 and the published results of supervised exercise, the expected benefit of remotely supervised exercise is about 180 metres extra walking distance, with a standard deviation of 150m in both groups. With alpha=0.05 (5% false positive rate) and beta=0.1 (90% power), 16 patients in each arm are required to demonstrate a mean difference in the primary endpoint of 180 metres, using a 2 sided t-test (MedCalc statistical software, Belgium). The sample size will be 20+20 patients from Mid and South Essex Trust vascular outpatient clinics. Follow up There will be 3 assessment visits: baseline, 3 months and 6 months performed with a study clinician. The primary endpoint will be measured blind to treatment allocation by asking the patient to walk along a flat, hospital corridor until they need to stop due to leg pain. This will be measured at 0, 3 and 6 months. The secondary endpoint will be through patient questionnaires and scored by an independent observer at baseline, 3 and 6 months. Ankle-brachial pressure index will be measured by an independent vascular scientist at the start and end of the study. Patient satisfaction will be measured at 3 months using a self-reported questionnaire. Adherence to exercise will be measured through submission of walking logs at 1, 2 and 3 months.

Official Title
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Remotely Supervised Exercise Versus Self-Directed Exercise: Phase II Safety and Efficacy Study

Conditions
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Claudication, Intermittent, Peripheral Arterial Disease

Intervention / Treatment
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* Behavioral: Remotely supervised exercise programme
* Behavioral: Self-directed exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arterial claudication with ABPI <0.9 or post-treadmill pressure drop of >20mmHg Able to walk 50 metres unaided Willing to try and give up smoking Willing to take antiplatelet, rivaroxaban and statin Has a smartphone or pedometer or watch Has an email account Adult > 18 years old Able to give informed consent Exclusion Criteria: Nocturnal foot pain or tissue loss Use of walking stick, frame or wheelchair Severe COPD or heart failure or arthritis Home oxygen Major amputation and non-limb wearer Severe hearing or visual impairment Prior failed exercise regime Prior falls Cognitive impairment Unable to work due to severity of claudication

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
Interventional Model Description: Pilot 2 arm RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remotely supervised exercise<br>Best medical therapy including aspirin 75mg od + rivaroxaban 2.5mg bd (if not tolerated clopidogrel 75mg od), atorvastatin 80mg and smoking cessation referral as per NICE guideline for PAD. Intervention = electronic walking log and fortnightly video/telephone call with physiotherapist for 3 months. | Behavioral: Remotely supervised exercise programme<br>* Electronic walking log Fortnightly video/telephone calls with physiotherapist<br>|
| Active Comparator: Self-directed exercise<br>Best medical therapy including aspirin 75mg od + rivaroxaban 2.5mg bd (if not tolerated clopidogrel 75mg od), atorvastatin 80mg and smoking cessation referral as per NICE guideline for PAD. Control = electronic walking log and instructions to exercise 4 times per week for 3 months | Behavioral: Self-directed exercise<br>* Electronic walking log and instructions to exercise 4 times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in absolute walking distance | Indoor flat surface walking distance until leg pain stops patient walking. | 3 and 6 months post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease specific quality of life | Intermittent Claudication Questionnaire (0 best - 100 worst) | 3 and 6 months post randomisation | 
| Unplanned revascularisation | Any endovascular, open or hybrid revascularisation during follow up | 6 months | 
| Patient satisfaction | Patient satisfaction questionnaire (1 would never recommend - 5 would strongly recommend) | 3 months | 
| Adherence | Adherence with 2 hours exercise per week (judged via submitted walking logs) | 1, 2 and 3 months |