Ignite Creation Date:
2024-05-06 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03394183
Status:
WITHDRAWN
Last Update Posted:
2018-10-12
First Post:
2017-12-15
Brief Title:
Efficacy of Cardiac Rehab for Patients With Peripheral Artery Disease Versus Patients With Coronary Artery Disease
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Comparing the Efficacy of Cardiac Rehabilitation for Patients With Peripheral Artery Disease to Patients With Coronary Artery Disease
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient study personnel
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 practicesTo 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-36The 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 claudicationExploratory 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 15 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None