Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers
- Conditions
- Peripheral Artery Disease
- Registration Number
- NCT07012070
- Lead Sponsor
- Chinese University of Hong Kong
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in 6-minute walk test distance 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
- Secondary Outcome Measures
Name Time Method compliance to treatment 12 weeks, 26 weeks Compliance to exercise therapy will be measured as the percentage of participation in the SET session in the control arm, and percentage of exercise program activation in the intervention arm.
change in claudication symptoms 12 weeks, 26 weeks claudication symptoms as measured by the Walking Impairment Questionnaire which was The WIQ is a short, validated questionnaire for patients with peripheral arterial disease that is easy to complete. It contains three domains to assess walking impairment: walking distance, walking speed, and stair climbing. For each domain, a sub-score of the Likert items was calculated. The mean of these domains represents the total WIQ score. The Chinese version of the WIQ has been validated by our centre against the claudication symptoms and showed to be a reliable and clinically relevant instrument
change in quality of life 12 weeks, 26 weeks The 36-items short-form (SF-32) health survey score score will be converted to SF-6D index score which is a preference-based measure of health-related quality of life (HRQoL) for its descriptive ability. The SF-6D index score will be used in the subsequent cost-effectiveness analysis.
change in endothelial function 12 weeks, 26 weeks endothelium function will be evaluated using the Flow-mediated dilatation (FMD). The test will be performed in a quiet, temperature-controlled room with the subject lying supine. Subjects are advised to refrain from ingesting caffeine, high-fat foods and vitamin C or use tobacco for at least 6 hours prior to the study. After a qualified image is acquired for analysis, a pressure cuff placed distal to the imaging probe at the forearm will be inflated to 50mmHg above the systolic pressure for 5 minutes. The longitudinal image of the brachial artery is scan continuous for 3 minutes after the deflation of the cuff. The percentage change in peak brachial artery diameter before and after the cuff inflation will be calculated automatically and reported as the FMD of the subject.
change in arterial compliance 12 weeks, 26 weeks arterial compliance as measured by the carotid-femoral pulse-wave velocity which is is a well-validated surrogate measurement of arteria stiffness and is an important prognostic marker for future cardiovascular event39. Several previous studies have shown a reduction in cfPWV after a period of exercise training in non-PAD individuals. The Vicorder (software version 4; Skidmore Medical) which uses the oscillometric technique to acquire the pulse waveform, will be used for cfPWV measurement. Measurements of cfPWV will be obtained by using a 10-cm-wide cuff around the right upper thigh to detect the femoral pulse and a 3-cm cuff around the neck to detect the right carotid pulse. The distance between the suprasternal notch and mid upper thigh cuff is used as the travel distance between the carotid and the femoral cuff. The cfPWV is calculated automatically as cfPWV (m/s)=distance (m)/transit time (s)
change in lower limb perfusion 12 weeks, 26 weeks lower limb perfusion as measured by Exercise ankle-brachial index (ABI) and Transcutaneous oxygen tension (TcPO2) .Exercise ABI will be performed using the Gardener progressive graded treadmill protocol (2mph, 0% grade with 2% increase every 2 minutes) until maximal claudication pain or for a maximum of 5 minutes. Immediately after exercise, the patient is asked to lie in a supine position and ABI test is repeated. The difference between the resting ABI and post exercise ABI reflects lower limb perfusion on exertion.
change in calf muscle strength 12 weeks, 26 weeks The assessment of isometric muscle strength of the lower extremities will be assessed for knee extension, knee flexion, ankle plantarflexion, and ankle dorsiflexion. All tests will assess the muscle strength by the peak force and the rate of force development using a hand- held dynamometer (microFET2, Hoggan Scientific, Salt Lake City UT, USA) which has been shown to have excellent correlation with the criterion-reference dynamometers42. The presence of PAD significantly weakened lower extremity power43. However, the impact of exercise on muscle strength has not been definitively ascertained44
change in blood inflammatory markers 12 weeks, 26 weeks Blood Tests for cardiovascular risk factors including Haemoglobin A1c as measured in percentage of glycated hemoglobin and lipid profile as measured in mmol/l will be sent to local laboratory for processing. Additional blood tests for high-sensitivity C- reactive protein (hs-CRP) as measured in mg/L, and interleukin-6 (IL-6) as measured in pg/ml will be sent to an accredited medical laboratory for processing as these parameters are not available as a routine blood test at the local laboratory.
cost-effectiveness 12 weeks, 26 weeks Cost-effectiveness analysis will be carried out from a health-care payer perspective, and non health-care consequences such as effects on production loss or cost of transportation to the health-care facility will not be considered. The cost for each treatment will be calculated with reference to the gazetted price from the Hospital Authority. The current listed price for SET is HKD 2830, and the cost for eHBET involves only the WAM which is listed at HKD800. The incremental cost-effectiveness ratio (ICER) will be calculated using between group cost difference divided by difference in HRQoL. Following the World Health Organization's guidelines, we defined the willingness-to-pay (WTP) threshold as 1 times the local gross domestic product per capita (which is US $49,146= HKD 384,284 in 2021), and the treatment is considered cost-effective if the ICER of the treatment is lower than the WTP threshold.
change in skin perfusion 12 weeks, 26 weeks TcPO2 measures the local oxygen released from the capillaries through the skin, reflecting the metabolic state of the lower limb. The reproducibility of TcPO2 is much higher than ABI therefore allowing for a detection of a relatively small changes in lower limb perfusion after any therapeutic intervention. TcPO2 will be measured using the Perimed Periflux System 6000 (Perimed Corporation, Stockholm, Sweden) with the patient lying supine in a well-lit and temperature-controlled room. Two electrodes whose membranes are maintained at 45°C are placed on the dorsum of the foot and equilibration will be allowed before taking any measurement.
Trial Locations
- Locations (1)
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong