Clinical trial NCT07012070: Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: wearables
SET
HBET
PAD
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Research Grants Council, Hong Kong
First posted: 2025-06-10
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-centre, open-labelled, parallel-arm, randomized controlled trial. The target population is patients with a diagnosis of symptomatic PAD as defined by the presence of lifestyle limiting claudication and an ankle-brachial-index (ABI) of \<0.9. Participants will be randomized at the ratio of 1:1 to receive SET (control), or HBET enhanced with WAM, and an app-based program installed on their mobile device that provides personalized auto- feedback based on their level of activities and lifestyle (treatment). The proposed sample size will be 70 with 35 patients in each arm.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change in 6-minute walk test distance
timeFrame: 12 weeks, 26 weeks
Secondary outcomes:
measure: compliance to treatment
timeFrame: 12 weeks, 26 weeks
measure: change in claudication symptoms
timeFrame: 12 weeks, 26 weeks
measure: change in quality of life
timeFrame: 12 weeks, 26 weeks
measure: change in endothelial function
timeFrame: 12 weeks, 26 weeks
measure: change in arterial compliance
timeFrame: 12 weeks, 26 weeks
measure: change in lower limb perfusion
timeFrame: 12 weeks, 26 weeks
measure: change in calf muscle strength
timeFrame: 12 weeks, 26 weeks
measure: change in blood inflammatory markers
timeFrame: 12 weeks, 26 weeks
measure: cost-effectiveness
timeFrame: 12 weeks, 26 weeks
measure: change in skin perfusion
timeFrame: 12 weeks, 26 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: GuangMing Tan
role: PRINCIPAL_INVESTIGATOR
References: