RESET2: REmotely Supervised Exercise Therapy Trial 2
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Remotely supervised exercise 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
Electronic walking log Fortnightly video/telephone calls with physiotherapist
|
| Active Comparator: Self-directed exercise 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
Electronic walking log and instructions to exercise 4 times per week.
|
Outcome Measures
Primary Outcome Measures
- Change in absolute walking distance [3 and 6 months post randomisation]
Indoor flat surface walking distance until leg pain stops patient walking.
Secondary Outcome Measures
- Change in disease specific quality of life [3 and 6 months post randomisation]
Intermittent Claudication Questionnaire (0 best - 100 worst)
- Unplanned revascularisation [6 months]
Any endovascular, open or hybrid revascularisation during follow up
- Patient satisfaction [3 months]
Patient satisfaction questionnaire (1 would never recommend - 5 would strongly recommend)
- Adherence [1, 2 and 3 months]
Adherence with 2 hours exercise per week (judged via submitted walking logs)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Arterial claudication with ABPI <0.9 or post-treadmill pressure drop of >20mmHg
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Able to walk 50 metres unaided
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Willing to try and give up smoking
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Willing to take antiplatelet, rivaroxaban and statin
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Has a smartphone or pedometer or watch
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Has an email account
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Adult > 18 years old
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Able to give informed consent
Exclusion Criteria:
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Nocturnal foot pain or tissue loss
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Use of walking stick, frame or wheelchair
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Severe COPD or heart failure or arthritis
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Home oxygen
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Major amputation and non-limb wearer
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Severe hearing or visual impairment
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Prior failed exercise regime
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Prior falls
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Cognitive impairment
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Unable to work due to severity of claudication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mid and South Essex Hospitals NHS Foundation Trust | Basildon | Essex | United Kingdom | SS16 5NL |
Sponsors and Collaborators
- Mid and South Essex NHS Foundation Trust
Investigators
- Principal Investigator: Ankur Thapar, PhD, Mid and South Essex Hospitals NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2987694