Using wearable activity trackers and a mobile app to help people with peripheral artery disease walk better

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.