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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Mid and South Essex Hospitals NHS Foundation Trust
RECRUITING
Basildon
Contact Information
Primary
Ankur Thapar, PhD
a.thapar@nhs.net
012685249000
Backup
Ashley Solieri
Ashley.solieri@btuh.nhs.uk
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 40
Treatments
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.
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
Sponsors
Leads: Mid and South Essex NHS Foundation Trust

This content was sourced from clinicaltrials.gov