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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in 6-minute walk test distance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SET
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.
干预措施: Mobile application (Behavioral)
SET
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.
干预措施: supervised exercise therapy (SET) (Behavioral)
SET
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.
干预措施: Wearable activities monitor (WAM) (Device)
eHBET
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.
干预措施: Wearable activities monitor (WAM) (Device)
eHBET
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.
干预措施: enhanced HBET (Behavioral)
eHBET
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.
干预措施: Mobile application (Behavioral)
结局指标
主要结局
Change in 6-minute walk test distance
时间窗: 12 weeks, 26 weeks
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
次要结局
- change in lower limb perfusion(12 weeks, 26 weeks)
- 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)
- change in calf muscle strength(12 weeks, 26 weeks)
- change in blood inflammatory markers(12 weeks, 26 weeks)
- cost-effectiveness(12 weeks, 26 weeks)
- change in skin perfusion(12 weeks, 26 weeks)
研究者
GuangMing Tan
Assistant professor
Chinese University of Hong Kong