REmotely Supervised Exercise Therapy Trial 2

NCT04925219 | Unknown

• 1 other identifier: 2987694
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Claudication, Intermittent; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Change in absolute walking distance

  Indoor flat surface walking distance until leg pain stops patient walking.

  3 and 6 months post randomisation

Secondary Outcomes (4)

• Change in disease specific quality of life

  3 and 6 months post randomisation

• Unplanned revascularisation

  6 months

• Patient satisfaction

  3 months

• Adherence

  1, 2 and 3 months

Study Arms (2)

Remotely supervised exercise

EXPERIMENTAL

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

Self-directed exercise

ACTIVE COMPARATOR

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

Interventions

Remotely supervised exercise programme BEHAVIORAL

Electronic walking log Fortnightly video/telephone calls with physiotherapist

Remotely supervised exercise

Self-directed exercise BEHAVIORAL

Electronic walking log and instructions to exercise 4 times per week.

Self-directed exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead

Study Sites (1)

Mid and South Essex Hospitals NHS Foundation Trust

Basildon, Essex, SS16 5NL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Ankur Thapar, PhD

  Mid and South Essex Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ankur Thapar, PhD

CONTACT

012685249000; a.thapar@nhs.net

Ashley Solieri

CONTACT

Ashley.solieri@btuh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent assessment of absolute walking distance and QoL.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot 2 arm RCT

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: June 14, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon publication
• Access Criteria: Upon request to PI

Locations

GB (1)