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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03394183
• Other study ID #: PVC
• Status: Withdrawn
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: October 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 15, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute Rumsey Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute Exercise Responses	Comparing exercising heart rate, rating of perceived exertion, and exercise prescriptions between PAD and CAD participants	6 months
Primary	Cardiorespiratory Fitness	Relative VO2peak in ml/kg/min	6 months
Secondary	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)	6 months