Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers

NCT07012070 | Recruiting DMC

• 1 other identifier: 2023.548
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Artery Disease

Keywords

wearables; SET; HBET; PAD

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walk test distance

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity

  12 weeks, 26 weeks

Secondary Outcomes (10)

• compliance to treatment

  12 weeks, 26 weeks

• change in claudication symptoms

  12 weeks, 26 weeks

• change in quality of life

  12 weeks, 26 weeks

• change in endothelial function

  12 weeks, 26 weeks

• change in arterial compliance

  12 weeks, 26 weeks

Study Arms (2)

SET

ACTIVE COMPARATOR

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.

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

eHBET

EXPERIMENTAL

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.

Device: Wearable activities monitor (WAM); Behavioral: enhanced HBET; Behavioral: Mobile application

Interventions

supervised exercise therapy (SET) BEHAVIORAL

Supervised exercise therapy (SET) is a structured program of exercise designed for individuals with peripheral artery disease (PAD) and intermittent claudication (IC). It consists of 12 weeks of intermittent treadmill walking to moderate to severe claudication pain at a speed of ≈2 mph and at a grade equal to 40% of the highest workload achieved during the baseline maximal treadmill test, with intermittent period of rest, for at least 3 times per week with a minimum of 30-45 minutes per session

SET

Wearable activities monitor (WAM) DEVICE

The WAM use in this study is the FitBit Inspire 3 Advanced Activity Tracker (FitBit Inc. San Francisco, CA, USA), which is a commercially available tri-axis accelerometer and heart rate monitor capable of continuous monitoring of heart rate using LED sensor, and activities including daily steps count and derived daily activity level, detection of arrythmia and measuring peripheral capillary oxygen saturation. Fitbit devices connect with HOBBIT-PAD platform which was developed specifically for patients with PAD based on user-centred design. It contains patient education information, instruction for exercise, activity record, and embedded messaging function between the patient and the research team about any technical and clinical issue. Important and thorough customizations will be made to tailor this mobile health platform for this study, which includes the addition of patient education materials on PAD and its management, tips on health eating and lifestyle, and tips on exercise.

SET; eHBET

enhanced HBET BEHAVIORAL

Instructions for HBET are programmed according to the AHA recommendation on the exercise programs for patients with PAD and are automatically generated by the mobile apps. Patients will be prompted to use the exercise function on the mobile apps at least 3 times per week. Once the exercise function is activated, it will extract the steps counts and the walking pace from the WAM during exercise. Patients will be instructed to walk to maximal claudication symptom before stopping, at which point they will press pause on the WAM which will mark the claudication onset time. After the claudication subside, they can resume walking and resume recording on their WAM. Each exercise session will last for 45 minutes excluding rest periods, but the subject can terminate the exercise before the session ends.

eHBET

Mobile application BEHAVIORAL

The mobile apps and mobile platform are adopted from the HOBBIT-PAD platform prototype that was developed specifically for patients with PAD based on user-centred design. This platform contains patient education information, instruction for exercise, activity record, and embedded messaging function between the patient and the research team about any technical and clinical issue. The source code for this platform is publicly available. Important customization will be made to tailor this mobile health platform for this study, which includes addition of patient education materials on PAD and its management, tips on health eating and lifestyle, and tips on exercise. These materials are adopted from the patient education materials available on the Hospital Authority and the AHA website. This information will be periodically sent to the subject's mobile device as a push notification to help them better understand their disease and to promote independent self-care and healthy lifestyle.

SET; eHBET

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are newly diagnosed with symptomatic claudication as defined by the presence of claudication symptoms elicited by the single claudication question
• Patients who ABI \<0.9 are the primary target population

You may not qualify if:

• Patients is inability to ambulate without walking aids or understand the instruction of exercise
• Patients have history of previous percutaneous or surgical revascularization of lower limb
• Patients is presence of critical limb ischemia or gangrene
• Patients has history of major amputation of the lower limb
• Patients is presence of other co-morbidities which limit walking ability
• Patients is presence of cardiovascular instability which includes unstable angina or acute coronary syndrome
• Patients diagnosed active class III/IV heart failure
• Patients is inability to operate simple electronic devices
• Patients is inaccessibility of a mobile network service in the place of residence
• Patients is unwillingness in sharing individual data to study team
• Patients is life-expectance less than 6 months

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Research Grants Council, Hong Kong: collaborator

Study Sites (2)

Prince of Wales Hospital

Hong Kong, Hong Kong, 0000, Hong Kong

RECRUITING

Prince of Wales Hospital

Hong Kong, Shatin, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• GuangMing Tan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Xu

CONTACT

97645701; danielxu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

HK (2)