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Cardiac Rehabilitation Program in Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Rehabilitation Program
Conventional Therapy
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Arterial Disease focused on measuring revascularization, blocked arteries, leg arteries, leg pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with PAD post-revascularization (stent, angioplasty, or bypass).
  • Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures.

Exclusion Criteria:

  • Below or above the knee amputation.
  • Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC).
  • Unfavorable short term prognosis and limited life expectancy (<2 years)
  • Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned).
  • Prior history of having dropped out of CR without completing.
  • Unwilling to consent for all aspects of CR or study participation.
  • Unable to come for CR (this will exclude patients who live far away or have no means to travel to the CR facility).
  • Pregnancy

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardiac Rehabilitation Group

Control Group

Arm Description

Participants randomized to this group will undergo cardiac rehabilitation program.

Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.

Outcomes

Primary Outcome Measures

Change in 6 minute walk test
Results will be measured in meters.

Secondary Outcome Measures

Short Form Health Survey 36 (SF-36)
Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
Short Form Health Survey 36 (SF-36)
Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
Vascular Quality of Life Questionnaire-6 (VascuQol6)
The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
Vascular Quality of Life Questionnaire-6 (VascuQol6)
The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
Absolute Claudication Distance (ACD)
ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters
Functional Claudication Distance (FCD)
FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters.

Full Information

First Posted
August 11, 2017
Last Updated
September 5, 2019
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03251391
Brief Title
Cardiac Rehabilitation Program in Peripheral Arterial Disease
Official Title
To Assess the Safety and Feasibility of a Structured Cardiac Rehabilitation Program in Patients With Peripheral Arterial Disease After Successful Revascularization Procedures: A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
May 11, 2019 (Actual)
Study Completion Date
May 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
revascularization, blocked arteries, leg arteries, leg pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Rehabilitation Group
Arm Type
Experimental
Arm Description
Participants randomized to this group will undergo cardiac rehabilitation program.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.
Intervention Type
Other
Intervention Name(s)
Cardiac Rehabilitation Program
Intervention Description
Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months. Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information.
Intervention Type
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
Participants will be asked to complete tests and questionnaires that would normally be done for their condition.
Primary Outcome Measure Information:
Title
Change in 6 minute walk test
Description
Results will be measured in meters.
Time Frame
Change from Baseline to Up to 6 Months
Secondary Outcome Measure Information:
Title
Short Form Health Survey 36 (SF-36)
Description
Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
Time Frame
Change from Baseline to Up to 6 Months
Title
Short Form Health Survey 36 (SF-36)
Description
Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
Time Frame
Change from Baseline to Week 18
Title
Vascular Quality of Life Questionnaire-6 (VascuQol6)
Description
The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
Time Frame
Change from Baseline to Up to 6 Months
Title
Vascular Quality of Life Questionnaire-6 (VascuQol6)
Description
The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
Time Frame
Change from Baseline to Week 18
Title
Absolute Claudication Distance (ACD)
Description
ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters
Time Frame
Change from Baseline to Up to 6 Months
Title
Functional Claudication Distance (FCD)
Description
FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters.
Time Frame
Change from Baseline to Up to 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with PAD post-revascularization (stent, angioplasty, or bypass). Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures. Exclusion Criteria: Below or above the knee amputation. Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC). Unfavorable short term prognosis and limited life expectancy (<2 years) Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned). Prior history of having dropped out of CR without completing. Unwilling to consent for all aspects of CR or study participation. Unable to come for CR (this will exclude patients who live far away or have no means to travel to the CR facility). Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamal Gupta, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Cardiac Rehabilitation Program in Peripheral Arterial Disease

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