Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394183
Recruitment Status : Withdrawn (Insufficient study personnel)
First Posted : January 9, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Cindy Nguyen, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE December 15, 2017
First Posted Date  ICMJE January 9, 2018
Last Update Posted Date October 12, 2018
Estimated Study Start Date  ICMJE August 15, 2018
Estimated Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Cardiorespiratory Fitness [ Time Frame: 6 months ]
Relative VO2peak in ml/kg/min
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • Cardiorespiratory Fitness [ Time Frame: 6 months ]
    Relative VO2peak in ml/kg/min
  • Functional Capacity [ Time Frame: 6 months ]
    6 Minute Walk Test Distance in meters
  • Walking Impairment [ Time Frame: 6 months ]
    Walking Impairment Questionnaire (WIQ) score; There are three subcategories (walking endurance, walking speed, and stair climbing ability). All three subcategories have a minimum score of 0 representing inability to complete tasks and the maximum score is 100 representing no difficulty with any of the tasks (range 0 to 100). Higher values represent better outcomes for this questionnaire. The total score is the mean of the three subscores.
  • Quality of Life [ Time Frame: 6 months ]
    Short-Form 36 Health Survey score; There are eight subcategories for this questionnaire including Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well-Being, Social Functioning, Pain, and General Health. Each subcategory has a minimum score of 0 with a maximum score of 100 (range 0 to 100). Higher values for each subcategory represent better quality of life outcomes.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
Magnitude of Response [ Time Frame: 6 months ]
To determine if the magnitude of response is dependent on biological sex or type of PAD (asymptomatic, post-surgical intervention, intermittent claudication)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 5, 2018)
Acute Exercise Responses [ Time Frame: 6 months ]
Comparing exercising heart rate, rating of perceived exertion, and exercise prescriptions between PAD and CAD participants
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Cardiac Rehab for Patients With Peripheral Artery Disease Versus Patients With Coronary Artery Disease
Official Title  ICMJE Comparing the Efficacy of Cardiac Rehabilitation for Patients With Peripheral Artery Disease to Patients With Coronary Artery Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Condition  ICMJE
  • Peripheral Arterial Disease
  • Coronary Artery Disease
  • Vascular Diseases
Intervention  ICMJE Other: Cardiac Rehabilitation
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.
Study Arms  ICMJE
  • Experimental: Peripheral Artery Disease Participants
    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.
    Intervention: Other: Cardiac Rehabilitation
  • Active Comparator: Coronary Artery Disease Participants
    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: Other: Cardiac Rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2018)
56
Estimated Study Completion Date  ICMJE June 15, 2019
Estimated Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03394183
Other Study ID Numbers  ICMJE PVC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cindy Nguyen, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE University of Toronto
Investigators  ICMJE
Study Chair: Paul Oh University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP