Home-based Walking Program With Smart Devices
Stopped early · Not applicable
Conditions studied: PAD - Peripheral Arterial Disease
In brief
Intermittent claudication (IC), the most common manifestation of peripheral artery disease (PAD), represents not only a significant detriment in quality of life, but also an increased risk for atherosclerotic cardiovascular disease (ASCVD), including progression of PAD, coronary artery disease (CAD) and cerebrovascular disease. Guideline directed therapy for IC includes supervised exercise, smoking cessation and optimal medical management to decrease overall risk of ASCVD. In the VA Health Care System, implementation of supervised exercise therapy through cardiac rehabilitation or physical therapy programs is limited by distances that patients must travel to VA facilities that provide these services. Furthermore, one of the most common failure points in exercise therapy programs is poor patient compliance. Improved patient participation and compliance in exercise programs for IC represents an unmet need, without which the majority of patients with life-style limiting PAD may not be receiving optimal medical management. Small studies have demonstrated the effectiveness of home-based exercise programs as an alternative to supervised exercise therapy; however, the success of the home-based exercise programs require remote coaching and/or regular provider feedback. The wide-spread availability of smart phones and smart devices has accelerated the implementation of telehealth programs that may supplement or may eventually replace in-person encounters for health care delivery. The role of provider feedback in addition to real-time feedback from smart devices remains completely unexplored. Our central hypothesis is that in individuals with IC, regular provider feedback on smart-device-based remote health monitoring data, which is available to the patient in real time, will augment the benefits of home-based exercise programs. We propose a randomized trial in patients with IC to test the central hypothesis through two Specific Aims: 1. To determine the effect of provider feedback on smart-device-based remote health monitoring data during home-based exercise programs on walking distance in patients with IC. 2. To determine the effect of provider feedback on smart-device-based remote health monitoring data during home-based exercise programs on quality of life (QOL) in patients with IC. Based on a sample size calculation to detect a 50% increase in walking distance between the 2 groups, we expect to enroll 30 patients (15 in each group). Patient participation in the study will be concluded after 12 weeks. As an exploratory aim in the study, we will also (as an optional part of the study) collect plasma before and after the 12-weeks of exercise to investigate changes in lipid levels and plasma biomarkers associated with exercise therapy. This exploratory aim will generate preliminary data for future studies.
Key facts
- Study ID
- NCT04113057
- Run by
- Dallas VA Medical Center
- People needed
- 12
- Starts
- 2019-08-09
- Expected to finish
- 2021-05-31
- Last updated by the study team
- 2021-11-18
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Presence of documented PAD by ABI <0.90 at rest or ≥20% drop in claudication limited exercise ABI in either limb and one of the following criteria in the corresponding limb:
- i. Prior lower extremity revascularization ii. Known presence of flow-limiting stenosis (≥70%) by clinically indicated angiography, computed tomographic (CT) or magnetic resonance imaging (MRI), or Duplex ultrasonography (DUS)
- Documented diagnosis of intermittent claudication
- Enrollment in supervised exercise therapy through the institutional cardiac rehab program
You may not qualify if…
- Severe cardiac or pulmonary disease that precludes participation in an exercise-based study.
- Severe psychiatric or behavioral illness that precludes study participation
- Inability to provide informed consent
Where it is running
- Dallas VAMC — Dallas, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.