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

NCT03394183 | Withdrawn

• 1 other identifier: PVC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Coronary Artery Disease; Vascular Diseases

Keywords

cardiac rehabilitation; cardiorespiratory fitness; functional capacity; acute exercise response; quality of life

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory Fitness

  Relative VO2peak in ml/kg/min

  6 months

Secondary Outcomes (1)

• Magnitude of Response

  6 months

Other Outcomes (1)

• Acute Exercise Responses

  6 months

Study Arms (2)

Peripheral Artery Disease Participants

EXPERIMENTAL

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.

Other: Cardiac Rehabilitation

Coronary Artery Disease Participants

ACTIVE COMPARATOR

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.

Other: Cardiac Rehabilitation

Interventions

Cardiac Rehabilitation OTHER

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.

Coronary Artery Disease Participants; Peripheral Artery Disease Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with lower extremity PAD or CAD
• diagnosed with concomitant PAD and CAD

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Toronto: collaborator

Study Sites (1)

Toronto Rehabilitation Institute Rumsey Centre

Toronto, Ontario, M4G 2V6, Canada

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Coronary Artery Disease; Vascular Diseases

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Paul Oh

  University Health Network, Toronto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 9, 2018
• Study Start: August 15, 2018
• Primary Completion: March 31, 2019
• Study Completion: June 15, 2019
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)