Clinical trial NCT03394183: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Peripheral Arterial Disease
Coronary Artery Disease
Vascular Diseases
Keywords: cardiac rehabilitation
cardiorespiratory fitness
functional capacity
acute exercise response
quality of life
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2018-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: 6 months
Secondary outcomes:
measure: Magnitude of Response
timeFrame: 6 months
Other outcomes:
measure: Acute Exercise Responses
timeFrame: 6 months
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute Rumsey Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Paul Oh
role: STUDY_CHAIR
References: