Standardized Vascular Rehabilitation Program to Improve Patient Disease and Quality of Life

Stopped early · Not applicable

Conditions studied: Vascular Diseases, Peripheral Artery Disease, Peripheral Vascular Diseases

In brief

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 walking distance and quality of life surveys. Subjects will be in the VRP for 6-12 weeks and then be followed for 12 months after they complete the program. This is a single-site study at Baylor Scott \& White Heart Hospital-Plano.

Key facts

Study ID

NCT04335695

Run by

Baylor Research Institute

People needed

7

Starts

2019-12-13

Expected to finish

2022-01-24

Last updated by the study team

2022-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baylor Scott & White Heart Hospital- Plano — Plano, Texas, United States

Full record on ClinicalTrials.gov

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