REmotely Supervised Exercise Therapy Trial 2 (RESET2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Claudication, Intermittent
• Intervention / Treatment: Behavioral: Remotely supervised exercise programme; Behavioral: Self-directed exercise

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ankur Thapar, PhD; Phone Number: 012685249000; Email: a.thapar@nhs.net
• Study Contact Backup: Name: Ashley Solieri; Email: Ashley.solieri@btuh.nhs.uk

Study Locations

• United Kingdom
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • Recruiting
      • Mid and South Essex Hospitals NHS Foundation Trust
      • Contact: Ashley Solieri; Email: Ashley.solieri@btuh.nhs.uk
      • Contact: Carol Alves; Email: carol.alves@btuh.nhs.uk
      • Principal Investigator: Ankur Thapar, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust
• Investigators: Principal Investigator: Ankur Thapar, PhD, Mid and South Essex Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: 2987694

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The full data set will be made available to other researchers upon publication.
• IPD Sharing Time Frame: Upon publication
• IPD Sharing Access Criteria: Upon request to PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No