Using wearable activity trackers and a mobile app to help people with peripheral artery disease walk better
Impact of Wearable Activity Linked Kinetic Therapy on the Walking Performance and Vascular Health in Patients With Peripheral Artery Disease: A Randomized Clinical Trial (the WALK-PAD Trial)
NA · Chinese University of Hong Kong · NCT07012070
This project will test whether a personalized home walking program guided by wearable activity trackers and automatic feedback can help people with peripheral artery disease walk as well as supervised exercise sessions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 2 sites (Hong Kong, Hong Kong and 1 other locations) |
| Trial ID | NCT07012070 on ClinicalTrials.gov |
What this trial studies
This is a non-inferiority interventional comparison of supervised exercise therapy (SET) versus a personalized home-based exercise program (HBET) enhanced with wearable activity monitors (WAM) and a mobile application that provides automated feedback. Participants are adults with newly diagnosed symptomatic claudication, primarily those with ankle-brachial index (ABI) <0.9, who can walk without aids and operate simple electronic devices. The HBET arm uses WAM data and app-driven feedback to guide self-directed exercise, while the SET arm receives center-based supervised sessions. Key exclusions include prior lower-limb revascularization, critical limb ischemia, major amputation, severe heart failure, or inability to access mobile network services.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic claudication and ABI <0.9 who can ambulate without walking aids, understand exercise instructions, and have mobile network access and basic device skills.
Not a fit: Patients with critical limb ischemia, prior lower-limb revascularization or major amputation, severe heart failure or other conditions that limit walking, inability to operate electronic devices, or no mobile network access are unlikely to benefit from the home-based wearable approach.
Why it matters
Potential benefit: If successful, this approach could allow many patients to improve walking ability at home using affordable wearables and reduce the need to travel for supervised sessions.
How similar studies have performed: Supervised exercise therapy is a proven treatment for PAD, while prior home-based programs and wearable-assisted interventions have shown mixed results and this specific automated-feedback, WAM-enhanced HBET has not been directly compared to SET.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who are newly diagnosed with symptomatic claudication as defined by the presence of claudication symptoms elicited by the single claudication question 2. Patients who ABI \<0.9 are the primary target population Exclusion Criteria: 1. Patients is inability to ambulate without walking aids or understand the instruction of exercise 2. Patients have history of previous percutaneous or surgical revascularization of lower limb 3. Patients is presence of critical limb ischemia or gangrene 4. Patients has history of major amputation of the lower limb 5. Patients is presence of other co-morbidities which limit walking ability 6. Patients is presence of cardiovascular instability which includes unstable angina or acute coronary syndrome 7. Patients diagnosed active class III/IV heart failure 8. Patients is inability to operate simple electronic devices 9. Patients is inaccessibility of a mobile network service in the place of residence 10. Patients is unwillingness in sharing individual data to study team 11. Patients is life-expectance less than 6 months
Where this trial is running
Hong Kong, Hong Kong and 1 other locations
- Prince of Wales Hospital — Hong Kong, Hong Kong, Hong Kong (RECRUITING)
- Prince of Wales Hospital — Hong Kong, Shatin, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: GuangMing Tan — Chinese University of Hong Kong
- Study coordinator: Daniel Xu
- Email: danielxu@cuhk.edu.hk
- Phone: 97645701
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.
Conditions: Peripheral Artery Disease, wearables, SET, HBET, PAD