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

NCT04335695 | Terminated

• 1 other identifier: 019-309
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Vascular Diseases; Peripheral Artery Disease; Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (4)

• Changes in ankle brachial indices at baseline of VRP and at the termination of VRP (6-12 weeks) (ABI range 0-2)

  ABI will be obtained according to standard practice. Severe disease= \<=0.4; Mild to moderate disease= 0.41-0.9; Normal= \>1.0

  6-12 weeks (depending on time in the VRP)

• Changes to quality of life surveys at VRP enrollment, VRP discharge, and one year after discharge. Range 7-175

  Quality-of-life survey specific for vasculogenic claudication (VascuQoL) (Range QOL not impacted=175; QOL poorly impacted=7)

  Baseline to 1 year after discharge

• Changes to walking distance until symptoms of claudication at VRP enrollment, VRP discharge, and at one year post discharge

  Baseline to 1 year after discharge

• Changes to total walking distance at VRP enrollment, VRP discharge, and at one year post discharge

  These will be obtained in the VRP at beginning of VRP and termination of VRP. These measurements will also be obtained during the 3-month intervals may be obtained via telephone and remote patient monitoring via the activity tracker if possible. Pain scores related to the claudication will be recorded on a scale of 1-4.

  13-15 months

Secondary Outcomes (2)

• Determination of activity level evaluated on daily, weekly, monthly and cumulative levels

  Baseline to 1 year after discharge

• Rate of lower extremity revascularization intervention that occurs during the study period (1 year following program discharge).

  Baseline to 1 year after discharge

Study Arms (1)

Vascular Rehabilitation and Follow Up

OTHER

All subjects will be enrolled in a 6-12 Vascular Rehab Program (VRP) and then be followed for one year following discharge from the VRP.

Behavioral: Vascular Rehabilitation

Interventions

Vascular Rehabilitation BEHAVIORAL

Vascular rehabilitation is a supervised exercise therapy program that includes healthy lifestyle changes to help patients gain strength, energy and confidence to return to daily activities. A program of supervised exercise rehabilitation is considered a primary treatment for people with Peripheral Artery Disease and Intermittent Claudication. In addition, patients will be given a wrist-worn activity tracker and be in contact with a research coordinator every 3 months after they are discharged from the Vascular Rehab program.

Vascular Rehabilitation and Follow Up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Heart Hospital- Plano

Plano, Texas, 75093, United States

Location

Related Publications (5)

• Malgor RD, Alahdab F, Elraiyah TA, Rizvi AZ, Lane MA, Prokop LJ, Phung OJ, Farah W, Montori VM, Conte MS, Murad MH. A systematic review of treatment of intermittent claudication in the lower extremities. J Vasc Surg. 2015 Mar;61(3 Suppl):54S-73S. doi: 10.1016/j.jvs.2014.12.007. Epub 2015 Feb 23.

  PMID: 25721067 BACKGROUND

• Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.

  PMID: 28938901 BACKGROUND

• Conijn AP, Jens S, Terwee CB, Breek JC, Koelemay MJ. Assessing the quality of available patient reported outcome measures for intermittent claudication: a systematic review using the COSMIN checklist. Eur J Vasc Endovasc Surg. 2015 Mar;49(3):316-34. doi: 10.1016/j.ejvs.2014.12.002. Epub 2015 Jan 22.

  PMID: 25618453 BACKGROUND

• Conijn AP, Loukachov VV, Bipat S, Koelemay MJ. Test-retest Reliability and Measurement Error Are Excellent for the Dutch Version of the VascuQol Questionnaire in Patients with Intermittent Claudication. Eur J Vasc Endovasc Surg. 2015 Oct;50(4):502-5. doi: 10.1016/j.ejvs.2015.07.007. Epub 2015 Aug 8.

  PMID: 26264883 BACKGROUND

• Conijn AP, Jonkers W, Rouwet EV, Vahl AC, Reekers JA, Koelemay MJ. Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication. Cardiovasc Intervent Radiol. 2015 Oct;38(5):1112-8. doi: 10.1007/s00270-015-1060-0. Epub 2015 Mar 14.

  PMID: 25772399 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• William P Shutze, MD

  Baylor Scott & White Heart Hospital Plano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will enroll in the Vascular Rehab program at Baylor Scott \& White Heart Hospital and be followed for 1 year after the program ends.

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 6, 2020
• Study Start: December 13, 2019
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)