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)

Overview

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.

Interventions

• Behavioral supervised exercise therapy (SET)
  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
• Device Wearable activities monitor (WAM)
  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 pa
• Behavioral enhanced HBET
  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 th
• Behavioral Mobile application
  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 he

Primary outcome measures

• Change in 6-minute walk test distance [Time frame: 12 weeks, 26 weeks]

Secondary outcome measures (10)

• compliance to treatment [Time frame: 12 weeks, 26 weeks]
• change in claudication symptoms [Time frame: 12 weeks, 26 weeks]
• change in quality of life [Time frame: 12 weeks, 26 weeks]
• change in endothelial function [Time frame: 12 weeks, 26 weeks]
• change in arterial compliance [Time frame: 12 weeks, 26 weeks]
• change in lower limb perfusion [Time frame: 12 weeks, 26 weeks]
• change in calf muscle strength [Time frame: 12 weeks, 26 weeks]
• change in blood inflammatory markers [Time frame: 12 weeks, 26 weeks]
• cost-effectiveness [Time frame: 12 weeks, 26 weeks]
• change in skin perfusion [Time frame: 12 weeks, 26 weeks]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Hong Kong · 2 centers

• Prince of Wales Hospital — Hong Kong
• Prince of Wales Hospital — Hong Kong

Identifiers

NCT: NCT07012070 · 2023.548

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗