REmotely Supervised Exercise Therapy Trial 2

Peripheral Arterial Disease Clinical Trial

— RESET2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925219
• Other study ID #: 2987694
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Mid and South Essex NHS Foundation Trust
• Contact: Ankur Thapar, PhD
• Phone: 012685249000
• Email: a.thapar[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Claudication, Intermittent
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Remotely supervised exercise programme
Electronic walking log Fortnightly video/telephone calls with physiotherapist
• Self-directed exercise
Electronic walking log and instructions to exercise 4 times per week.

Locations

Country	Name	City	State
United Kingdom	Mid and South Essex Hospitals NHS Foundation Trust	Basildon	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in absolute walking distance	Indoor flat surface walking distance until leg pain stops patient walking.	3 and 6 months post randomisation
Secondary	Change in disease specific quality of life	Intermittent Claudication Questionnaire (0 best - 100 worst)	3 and 6 months post randomisation
Secondary	Unplanned revascularisation	Any endovascular, open or hybrid revascularisation during follow up	6 months
Secondary	Patient satisfaction	Patient satisfaction questionnaire (1 would never recommend - 5 would strongly recommend)	3 months
Secondary	Adherence	Adherence with 2 hours exercise per week (judged via submitted walking logs)	1, 2 and 3 months