An interventional study of Remotely supervised exercise programme and Self-directed exercise in Claudication, Intermittent and Peripheral Arterial Disease, sponsored by Mid and South Essex NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Mid and South Essex NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's planned enrollment of 40 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Mid and South Essex NHS Foundation Trust is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 Fortnightly video/telephone calls with physiotherapist
Electronic walking log and instructions to exercise 4 times per week.
Change in absolute walking distance
Indoor flat surface walking distance until leg pain stops patient walking.
Time frame: 3 and 6 months post randomisation
Change in disease specific quality of life
Intermittent Claudication Questionnaire (0 best - 100 worst)
Time frame: 3 and 6 months post randomisation
Unplanned revascularisation
Any endovascular, open or hybrid revascularisation during follow up
Time frame: 6 months
Patient satisfaction
Patient satisfaction questionnaire (1 would never recommend - 5 would strongly recommend)
Time frame: 3 months
Adherence
Adherence with 2 hours exercise per week (judged via submitted walking logs)
Time frame: 1, 2 and 3 months
Plan to share: Yes — The full data set will be made available to other researchers upon publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Upon publication
Access criteria: Upon request to PI
No publications or documents are linked to this record.
Started Jun 2021 (actual). Primary completion is estimated for Dec 2024, 42 months after the start.
Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's planned 42 months is close to that.
Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
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Mid and South Essex NHS Foundation Trust