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Clinical Trials/NCT03394183
NCT03394183
Withdrawn
Not Applicable

Comparing the Efficacy of Cardiac Rehabilitation for Patients With Peripheral Artery Disease to Patients With Coronary Artery Disease

University Health Network, Toronto1 site in 1 countryAugust 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
University Health Network, Toronto
Locations
1
Primary Endpoint
Cardiorespiratory Fitness
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2018
End Date
June 15, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cindy Nguyen

Principal Investigator

University Health Network, Toronto

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

Outcomes

Primary Outcomes

Cardiorespiratory Fitness

Time Frame: 6 months

Relative VO2peak in ml/kg/min

Secondary Outcomes

  • Magnitude of Response(6 months)

Study Sites (1)

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