Clinical trial NCT04925219: REmotely Supervised Exercise Therapy Trial 2
Official title: Remotely Supervised Exercise Versus Self-Directed Exercise: Phase II Safety and Efficacy Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Claudication, Intermittent
Peripheral Arterial Disease
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot 2 arm RCT
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in absolute walking distance
timeFrame: 3 and 6 months post randomisation
Secondary outcomes:
measure: Change in disease specific quality of life
timeFrame: 3 and 6 months post randomisation
measure: Unplanned revascularisation
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 3 months
measure: Adherence
timeFrame: 1, 2 and 3 months
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Mid and South Essex Hospitals NHS Foundation Trust
state: Essex
Study officials:
affiliation: Mid and South Essex Hospitals NHS Foundation Trust
name: Ankur Thapar, PhD
role: PRINCIPAL_INVESTIGATOR
References: