Actively Recruiting
Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers
Led by Chinese University of Hong Kong · Updated on 2025-06-10
70
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
R
Research Grants Council, Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
Peripheral Arterial Disease (PAD) of the lower extremities is common and prevalence of PAD is increasing in our aging population. The presence of PAD is associated with increased cardiovascular morbidity and mortality, reduced physical function and quality of life. Intermittent claudication is the most common symptom of PAD affecting about 30% of the patients. Supervised exercise therapy (SET) is safe and cost-effective therapy when compared with invasive revascularization, and is recommended as the first-line treatment for symptomatic PAD. However, SET is not readily available in the public healthcare system. Barriers to SET implementation include demands for healthcare resources and the inconvenience of travelling to designated centre for SET. Home-based exercise therapy (HBET) has been proposed as an alternative to SET as they are more accessible and more acceptable to patients, but the benefits of HBET compared to SET have not been consistently demonstrated in studies. Wearable activities monitor (WAM) have been proposed as an adjuvant to enhance the performance of HBET. However, there is no direct comparison of WAM enhanced HBET to SET. Furthermore, WAMs were mainly used for monitoring in HBET in the previous studies and patient feedback was conducted either in-person or over telephones by the researchers, which challenges the true meaning of HBET. In this study, we aim to evaluate the non-inferiority of personalized self-guided HBET enhanced with WAM and auto feedback mobile apps, to SET, in a randomized-controlled trial of patients with symptomatic PAD.
CONDITIONS
Official Title
Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients newly diagnosed with symptomatic claudication confirmed by claudication symptoms
- Patients with ankle-brachial index (ABI) less than 0.9
You will not qualify if you...
- Inability to walk without walking aids or to understand exercise instructions
- History of previous surgical or percutaneous revascularization of the lower limb
- Presence of critical limb ischemia or gangrene
- History of major lower limb amputation
- Presence of other medical conditions limiting walking ability
- Cardiovascular instability including unstable angina or acute coronary syndrome
- Diagnosed active class III or IV heart failure
- Inability to operate simple electronic devices
- No access to mobile network service at home
- Unwillingness to share personal data with the study team
- Life expectancy less than 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Prince of Wales Hospital
Hong Kong, Hong Kong, Hong Kong, 0000
Actively Recruiting
2
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong, 0000
Actively Recruiting
Research Team
D
Daniel Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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