Status:
TERMINATED
Standardized Vascular Rehabilitation Program to Improve Patient Disease and Quality of Life
Lead Sponsor:
Baylor Research Institute
Conditions:
Vascular Diseases
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to identify the type of patients being referred for the Vascular Rehabilitation Program (VRP) and to study the success rates of the program according to improvements in wa...
Detailed Description
Peripheral arterial occlusive disease (PAOD) affects 8.5 million people in the United States. One of the most common symptoms of PAOD is claudication. While there are surgical and endovascular treatme...
Eligibility Criteria
Inclusion
- Enrolled in the vascular rehabilitation program at The Heart Hospital Cardiac Rehabilitation Facility.
- Female or male patients ≥18 years of age.
- Patient must be accessible for treatment and follow-up.
- Agrees to wear the activity tracker wrist-worn device
- Agrees to the follow-up QOL survey schedule
- Agrees to the follow-up ABI schedule
- All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
Exclusion
- Declines participation in the study.
- Has a life-expectancy less than 18 months.
- Unable to complete necessary study follow-up procedures.
- Unwilling to wear the wrist-worn activity tracker device.
- Women who are pregnant.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
- severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
- home oxygen
- neurologic or orthopedic conditions limiting ability to appropriately comply with rehabilitation program.
- class III or class IV NY class congestive heart failure
- Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Key Trial Info
Start Date :
December 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04335695
Start Date
December 13 2019
End Date
January 24 2022
Last Update
October 14 2022
Active Locations (1)
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1
Baylor Scott & White Heart Hospital- Plano
Plano, Texas, United States, 75093