Remotely supervised exercise program for patients with claudication
Remotely Supervised Exercise Versus Self-Directed Exercise: Phase II Safety and Efficacy Study
This study tests whether a supervised exercise program done through video calls can help people with leg pain from claudication walk further than if they just exercise on their own.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mid and South Essex NHS Foundation Trust Academic / other |
| Locations | 1 site (Basildon, Essex) |
| Trial ID | NCT04925219 on ClinicalTrials.gov |
What this trial studies
This pilot trial compares the effectiveness of remotely supervised exercise therapy to self-directed exercise for patients suffering from intermittent claudication due to peripheral arterial disease. Participants will engage in a structured exercise program monitored through video calls and electronic logs, with assessments conducted at baseline, 3 months, and 6 months. The primary outcome will be the absolute walking distance achieved before experiencing leg pain, measured by a blinded clinician. The study aims to generate data for a larger trial based on initial feasibility findings.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with arterial claudication and the ability to walk 50 meters unaided.
Not a fit: Patients with severe comorbidities, cognitive impairments, or those unable to engage in any form of exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve walking distance and quality of life for patients with peripheral arterial disease.
How similar studies have performed: Previous studies have shown promising results for remotely supervised exercise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basildon, Essex
- Mid and South Essex Hospitals NHS Foundation Trust — Basildon, Essex, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ankur Thapar, PhD — Mid and South Essex Hospitals NHS Foundation Trust
- Study coordinator: Ankur Thapar, PhD
- Email: a.thapar@nhs.net
- Phone: 012685249000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.