Actively Recruiting

Phase Not Applicable
All Genders
NCT07012070

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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