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Efficacy of Cardiac Rehab for Patients With Peripheral Artery Disease Versus Patients With Coronary Artery Disease

Primary Purpose

Peripheral Arterial Disease, Coronary Artery Disease, Vascular Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cardiac Rehabilitation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Arterial Disease focused on measuring cardiac rehabilitation, cardiorespiratory fitness, functional capacity, acute exercise response, quality of life

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosed with lower extremity PAD or CAD
  • diagnosed with concomitant PAD and CAD

Exclusion Criteria:

  • vascular aneurysms, chronic heart failure, cancer, stroke, respiratory disease, or chronic kidney disease
  • foot ulcers or skin breakdowns which may impede ability to exercise
  • cannot follow instructions in English

Sites / Locations

  • Toronto Rehabilitation Institute Rumsey Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peripheral Artery Disease Participants

Coronary Artery Disease Participants

Arm Description

Patients diagnosed with peripheral artery disease will undergo a 6 month cardiac rehabilitation program that is standard of care at the Toronto Rehabilitation Institute Rumsey Centre.

Patients diagnosed with coronary artery disease will undergo a 6 month cardiac rehabilitation program that is standard of care at the Toronto Rehabilitation Institute Rumsey Centre. The responses to cardiac rehabilitation for participants with coronary artery disease will be compared to participants with peripheral artery disease.

Outcomes

Primary Outcome Measures

Cardiorespiratory Fitness
Relative VO2peak in ml/kg/min

Secondary Outcome Measures

Magnitude of Response
To determine if the magnitude of response is dependent on biological sex or type of PAD (asymptomatic, post-surgical intervention, intermittent claudication)

Full Information

First Posted
December 15, 2017
Last Updated
October 9, 2018
Sponsor
University Health Network, Toronto
Collaborators
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03394183
Brief Title
Efficacy of Cardiac Rehab for Patients With Peripheral Artery Disease Versus Patients With Coronary Artery Disease
Official Title
Comparing the Efficacy of Cardiac Rehabilitation for Patients With Peripheral Artery Disease to Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient study personnel
Study Start Date
August 15, 2018 (Anticipated)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
June 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
University of Toronto

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
Exercise is commonly recommended as a treatment for patients who present with peripheral artery disease (PAD). Although a great deal of research has supported the efficacy of exercise rehabilitation for PAD, it is infrequently implemented into clinical practices.To date, no comparison of cardiac rehabilitation efficacy and acute exercise responses has been made between patients with PAD and patients with coronary artery disease (CAD). Considering some of the parallels between the two conditions, as they are both atherosclerotic conditions, and the strong recommendations for exercise in both populations, it is worthwhile to compare the efficacy of cardiac rehabilitation responses. It is also unclear if the magnitude of response for PAD patients is dependent on biological sex and clinical presentation as this may influence the development of exercise prescriptions. This study will be a prospective two-arm cohort study with both groups (CAD and PAD) undergoing the same intervention (standard 6 month out-patient cardiac rehabilitation program offered at the Toronto Rehabilitation Institute Rumsey Centre). The primary variable of interest will be peak oxygen consumption (VO2peak) with a secondary variable of interest being functional capacity, as measured by the 6-minute walk test. Tertiary variables of interest will include walking impairment, as measured by the Walking Impairment Questionnaire, and quality of life, as measured by the Short Form-36 health survey (SF-36).The second objective of this study is to determine if the magnitude of responses to cardiac rehabilitation for patients with PAD are dependent on biological sex or type of PAD (asymptomatic, post-surgical intervention, or intermittent claudication).Exploratory objectives include comparing acute exercise responses (prescribed exercise training load, actual training load, exercising heart rate and rating of perceived exertion) between PAD and CAD patients.
Detailed Description
This study is a prospective two-arm cohort study with both groups (CAD and PAD) undergoing the same intervention (standard 6 month out-patient cardiac rehabilitation program offered at the Toronto Rehabilitation Institute Rumsey Centre). The standard 6-month out-patient cardiac rehabilitation program consists of weekly 1.5 hour visits to the TRI Rumsey Centre. After determining baseline VO2peak from the exercise stress test, an individualized walking exercise prescription will be developed by a cardiac rehabilitation supervisor which corresponds to approximately 60 to 80% of the participant's VO2peak. Participants will be invited to walk around the track and attend education sessions at the same time every week for six months. Patients will be encouraged to gradually increase their exercise time walking speed. Patients will be encouraged to exercise five times a week with four sessions occurring outside of the cardiac rehabilitation program. Both PAD and CAD participants will undergo the same standard cardiac rehabilitation program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Coronary Artery Disease, Vascular Diseases
Keywords
cardiac rehabilitation, cardiorespiratory fitness, functional capacity, acute exercise response, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All participants will be enrolled in the cardiac rehabilitation program which involves weekly 1.5 hour visits at the Toronto Rehabilitation Institute Rumsey Centre for 6 months. Each visit will consist of an exercise and a risk factor education lecture. Prior to the start of the program, participants will attend two assessment sessions with cardiac rehabilitation staff members to review medical history as well as complete a cardiopulmonary exercise test. During the cardiac rehabilitation program, participants will walk at 60-80% of their VO2peak heart rate based on the results of their exercise test, as per standard care procedures. Adjustments will be made to the patient's exercise prescription under the discretion of the cardiac rehabilitation supervisor, as per standard care procedures. Patients will also be asked to exercise an additional four times during the week on their own time for a total of five times per week, as per standard care procedures.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peripheral Artery Disease Participants
Arm Type
Experimental
Arm Description
Patients diagnosed with peripheral artery disease will undergo a 6 month cardiac rehabilitation program that is standard of care at the Toronto Rehabilitation Institute Rumsey Centre.
Arm Title
Coronary Artery Disease Participants
Arm Type
Active Comparator
Arm Description
Patients diagnosed with coronary artery disease will undergo a 6 month cardiac rehabilitation program that is standard of care at the Toronto Rehabilitation Institute Rumsey Centre. The responses to cardiac rehabilitation for participants with coronary artery disease will be compared to participants with peripheral artery disease.
Intervention Type
Other
Intervention Name(s)
Cardiac Rehabilitation
Intervention Description
Cardiac rehabilitation is a 6 month program in which patients enrolled attend weekly classes which consist of individualized exercise and risk factor education lectures. This intervention is consistent with standard care procedures for the Cardiovascular Prevention and Rehabilitation Program at the Toronto Rehabilitation Institute Rumsey Centre.
Primary Outcome Measure Information:
Title
Cardiorespiratory Fitness
Description
Relative VO2peak in ml/kg/min
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Magnitude of Response
Description
To determine if the magnitude of response is dependent on biological sex or type of PAD (asymptomatic, post-surgical intervention, intermittent claudication)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Acute Exercise Responses
Description
Comparing exercising heart rate, rating of perceived exertion, and exercise prescriptions between PAD and CAD participants
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with lower extremity PAD or CAD diagnosed with concomitant PAD and CAD Exclusion Criteria: vascular aneurysms, chronic heart failure, cancer, stroke, respiratory disease, or chronic kidney disease foot ulcers or skin breakdowns which may impede ability to exercise cannot follow instructions in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Oh
Organizational Affiliation
University Health Network, Toronto
Official's Role
Study Chair
Facility Information:
Facility Name
Toronto Rehabilitation Institute Rumsey Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 2V6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Cardiac Rehab for Patients With Peripheral Artery Disease Versus Patients With Coronary Artery Disease

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