ReSET2
Research type
Research Study
Full title
Remotely Supervised Exercise Therapy for intermittent claudication trial 2 A randomised, controlled, assessor blind, 2 arm trial to compare supervised versus unsupervised exercise therapy for patients with stable intermittent claudication.
IRAS ID
297694
Contact name
Ankur Thapar
Contact email
Sponsor organisation
Mid and South Essex NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
Supervised exercise for intermittent claudication is a first line therapy for stable peripheral arterial disease, as recommended by NICE and the European Society for Vascular Surgery. However 2/3 of UK trusts cannot implement this due to cost, equipment and logistical reasons.
During the COVID-19 lockdown we successfully performed a feasibility study of remotely supervised exercise using an electronic walking log and fortnightly video calls with a physiotherapist.
RESET aims to compare the benefit of remotely supervised exercise with self-directed exercise using an electronic walking log to measure distance and adherence.Summary of Results
Randomised controlled trial of remotely supervised exercise versus self-directed exercise for intermittent claudication (RESET 2 study)Introduction
Face to face supervised exercise has been recommended as the first line therapy for intermittent claudication, however is not available in 2/3 of UK vascular units. During the COVID-19 pandemic we modified this intervention to become a remote physiotherapy programme over a 3 month period. This trial aimed to examine outcomes in comparison to self-directed exercise, which it could potentially replace.
Methods
A randomised single centre assessor blind trial. In the intervention arm fortnightly video or telephone calls from a physiotherapist with a tailored exercise prescription and review of progress with the aim of a minimum of 120 minutes of lower limb exercise per week. In the comparator arm patients were asked to do this themselves. Both groups had an automatic walking logbook which was inspected at follow ups at 3 and 6 months. The primary endpoint was absolute walking distance, which was assessed by an independent nurse blind to group allocation. The sample size calculation was a minimum of 16 patients in each arm.
Results
From May 2021 to May 2023, 44 patients were enrolled into the trial. 12 (27%) patients withdrew from the study for the following reasons (4 did not attend further appointments, 1 had a flare of ankle arthritis, 1 developed respiratory failure, 1 developed falls, 1 died and 1 moved out of area and 3 patients requires revascularisation. Of these, 2 patients had worsening claudication and required covered endovascular reconstruction of the aortic bifurcation (CERAB) and a femoropopliteal bypass and 1 patient who developed chronic limb threatening ischaemia underwent superficial femoral artery angioplasty.
There was no significant correlation between the baseline absolute walking distance and baseline ABPI across the groups (r=0.26, 95%CI -0.05 to 0.53, p=0.08, n= 44, Pearson – Figure 2).
Both groups have shown substantial benefits from exercising at 6 months, the absolute walking distance improved of 369m in the supervised group and 322m in the self-directed exercise group (p=0.72).
There was no significant change in the ABPIs at 6 months in both arms.
The adherence to the exercise program was overall above the recommended by national guidelines (median of 4 days in the remotely supervised group and 3 days in the self-directed group).
Both groups showed an improved quality of life as demonstrated by the results of the Intermittent Claudication Questionnaires at 6 months when compared to the baseline. The remotely supervised group gained 17/100 points and the self-directed group gained 10/100 points (p=0.10).Conclusion
Remote physiotherapy did not confer significant benefits to walking distance in this study.
REC name
West of Scotland REC 1
REC reference
21/WS/0052
Date of REC Opinion
17 May 2021
REC opinion
Further Information Favourable Opinion