Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers (WALK-PAD)

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Peripheral Artery Disease

Treatments: Device: Wearable activities monitor (WAM); Behavioral: supervised exercise therapy (SET); Behavioral: Mobile application; Behavioral: enhanced HBET

Study type: Interventional

Funder types: Other

Identifiers

NCT07012070

2023.548

Details and patient eligibility

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

SET

Active Comparator group

Description:

Supervised exercise therapy (SET) is The supervised program is conducted at the research institute under the supervision of a qualified healthcare provider. It consists of 12 weeks of intermittent treadmill walking to moderate to severe claudication pain at a speed of ≈2 mph. WAM will be offered to both intervention and control arms, but the mobile apps will only be installed for the subjects randomized to intervention arm. All subjects will receive from their physicians, according to the guidelines, cardiovascular risk management, cholesterol-lowering medication, antiplatelet therapy, the advice to stop smoking, and modification of other atherosclerotic risk factors that were present5. All borrowed devices will be returned at the end of the study.

Treatment:

Behavioral: Mobile application

Behavioral: supervised exercise therapy (SET)

Device: Wearable activities monitor (WAM)

eHBET

Experimental group

Description:

eHBET enhanced with Wearable Activities Monitor (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). Patients who are already using a smartwatch capable of the steps count and activity monitor before this study are allowed to use their own devices but are encouraged to switch to the FitBit watch for uniformity of data collection. Patients will be encouraged to wear the watch as often as possible during daytime and during sleep. Data gathered will be automatically transmitted wirelessly to a cloud-based platform provided by the manufacturer. The data from the WAM will be extracted and integrated to the mobile apps, accessible only by the research team and the patient. During the randomization visit, patients will be given simple instructions on how to operate the device and how to connect the device to the mobile apps.

Treatment:

Behavioral: enhanced HBET

Behavioral: Mobile application

Device: Wearable activities monitor (WAM)