Reduced Cardiac Rehabilitation Program

NCT ID: NCT01483235

Last Updated: 2011-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2011-09-30

Brief Summary

Standard cardiac rehabilitation programs (sCRP) aim to improve risk factors for heart disease such as high blood pressure, weight control, exercise and diet in order to decrease the chances of having heart problems in the future. These programs decrease morbidity and mortality but face important challenges: 1) Long waiting lists to participate in these programs. For example, St. Paul's Hospital has an intake capacity of 480 patients per year. Patients usually wait one to three months to start the program. 2) There is a vast heterogeneity of patients within the same program, from those that have never experienced heart problems to those that have already had a heart attack, chest pain or stroke. Therefore, patients with different medical problems receive the same treatment. 3) Facilities can be inconveniently located which leads to transportation difficulties, 4) The program is time consuming and classes are held in working times, 5) Shortly after completion, patients seem to lose what they have gained in the program. These caveats need to be addressed to improve the efficacy, delivery and capacity of sCRP for the increasing population of patients with heart disease.

The investigators want to compare a reduced cardiac rehabilitation program (rCRP) with the standard cardiac rehabilitation program (sCRP) in patients with risk factors for heart disease as well as patients that already suffer from this condition, including those at higher risk. The rCRP will offer the same services as the sCRP; the only difference is the number of hospital based exercise sessions. While the sCRP offers 32 hospital based supervised exercise sessions, the rCRP will offer 10 hospital based exercise sessions. The rCRP would be a 'middle of the road alternative program' that would have the benefits of a hospital based program and the flexibility of a home based intervention. The rCRP would offer an alternative for patients that do not need constant supervision and would allow the sCRP health care team to focus on those patients who have more serious heart conditions. The rCRP would be a unique intervention because it integrates a less intensive cardiac rehabilitation into the pre-existing sCRP model. This alternative would help overcome the caveats of standard cardiac rehabilitation programs.

Detailed Description

This study is a two group randomized controlled trial, non-inferiority design, where the rCRP (intervention group) will be compared with the sCRP (control group). Eligible patients will be asked to participate in the study at the cardiac rehabilitation program intake clinic. Consenting participants will be asked to sign an informed consent and undergo a baseline assessment. This assessment will consist of a medical history, exercise capacity (stress test), blood test, blood pressure, anthropometric measurements, lifestyle behaviours and psychosocial measurements. The baseline assessment will be done before participants start the program. Consecutively, randomization will take place stratified according to gender to either the sCRP or rCRP. The same assessment called exit assessment will be performed at four to six months from baseline, at the cardiac rehabilitation program exit clinic (at program completion) and at 16 to 20 months from baseline (one year follow-up from cardiac rehabilitation program completion) to assess the immediate and sustainable effect, respectively.

The following research questions will be addressed:

1. Is the reduced cardiac rehabilitation program (intervention group) as effective as the standard cardiac rehabilitation program (control group) for improving exercise capacity and ischemic heart disease risk factors at both program completion (four to six months from baseline) and at one year from program completion (16 to 20 months from baseline)?

2. Will the reduced cardiac rehabilitation program have better adherence than the standard cardiac rehabilitation program?

Conditions

Cardiovascular Disease; Obesity; Dyslipidemia

Keywords

cardiac rehabilitation; prevention; exercise capacity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Reduced cardiac rehabilitation (rCRP)

The rCRP is the intervention group, compared to the standard cardiac rehabilitation program group (sCRP). The rCRP will have the core elements of the sCRP, that is, in-hospital exercise sessions, dietary counseling, educational sessions, follow-up with the cardiologist, dietician and exercise specialist. The only difference will be the number of in-hospital exercise sessions (10 sessions for the rCRP v/s 32 sessions for the sCRP). Patients from rCRP will receive individual exercise guidelines, an educational package with questions of the week and a diary to record their exercise sessions (logbook), that will serve as a self-monitoring system.

Group Type: EXPERIMENTAL

Reduced cardiac rehabilitation group intervention (rCRP).

Intervention Type: BEHAVIORAL

The rCRP is a comprehensive intervention that will keep the same nature of therapies as the standard cardiac rehabilitation group (sCRP). The difference with the sCRP resides in the number of hospital based exercise sessions; instead of 32 sessions there will be 10 sessions spread throughout the 4 months of intervention (hence, not a shorter program). The rCRP intervention works within the sCRP. Hence, those randomized to the rCRP will be supervised in the same facility and by the same clinical staff as those in the sCRP. Patients from rCRP will receive individual exercise guidelines, an educational package with questions of the week and a diary to record their exercise sessions (logbook), that will serve as a self-monitoring system.

Standard cardiac rehabilitation (sCRP)

The standard cardiac rehabilitation (sCRP) follows the standard cardiac rehabilitation program model of a four-month period. Patients receive an initial intake evaluation by a cardiologist, nurse, exercise specialist and dietitian before starting the program. The program consists of 32, twice weekly in-hospital exercise sessions, educational sessions, nutritional counseling, medical care, psychological screening and smoking cessation if needed.

Group Type: ACTIVE_COMPARATOR

Standard cardiac rehabilitation intervention

Intervention Type: BEHAVIORAL

The standard cardiac rehabilitation is a multidisciplinary four-month intervention to modify ischemic heart disease risk factors and lifestyle behaviours. These programs aim to reduce morbidity and mortality by improving adherence to regular physical activity, a healthy diet and smoking cessation, as well as risk factor modification. Patients receive an initial intake evaluation by a cardiologist, nurse,exercise specialist and dietitian before starting the program. The program consists of 32, twice weekly in-hospital exercise sessions, educational sessions, nutritional counselling, medical care, psychological screening and smoking cessation if needed.

Interventions

Reduced cardiac rehabilitation group intervention (rCRP).

The rCRP is a comprehensive intervention that will keep the same nature of therapies as the standard cardiac rehabilitation group (sCRP). The difference with the sCRP resides in the number of hospital based exercise sessions; instead of 32 sessions there will be 10 sessions spread throughout the 4 months of intervention (hence, not a shorter program). The rCRP intervention works within the sCRP. Hence, those randomized to the rCRP will be supervised in the same facility and by the same clinical staff as those in the sCRP. Patients from rCRP will receive individual exercise guidelines, an educational package with questions of the week and a diary to record their exercise sessions (logbook), that will serve as a self-monitoring system.

Intervention Type: BEHAVIORAL

Standard cardiac rehabilitation intervention

The standard cardiac rehabilitation is a multidisciplinary four-month intervention to modify ischemic heart disease risk factors and lifestyle behaviours. These programs aim to reduce morbidity and mortality by improving adherence to regular physical activity, a healthy diet and smoking cessation, as well as risk factor modification. Patients receive an initial intake evaluation by a cardiologist, nurse,exercise specialist and dietitian before starting the program. The program consists of 32, twice weekly in-hospital exercise sessions, educational sessions, nutritional counselling, medical care, psychological screening and smoking cessation if needed.

Intervention Type: BEHAVIORAL

Other Intervention Names

rCRP; sCRP

Eligibility Criteria

Inclusion Criteria

1. Men and women (equal distribution) with risk factors for ischemic heart disease (primary prevention) or documented ischemic heart disease (secondary prevention) accepted in the cardiac rehabilitation program of St. Paul's Hospital.

2. Patients with documented ischemic heart disease (secondary prevention) classified as low and moderate risk according to the AACVPR risk stratification criteria for cardiac patients.

Exclusion Criteria

1. Patients with documented ischemic heart disease (secondary prevention)at high risk according to the AACVPR risk stratification criteria for cardiac patients.

2. Patients will also be excluded if they have the following:

• Uncontrolled metabolic factors (renal failure, uncontrolled diabetes, endocrinopathies
• Scheduled revascularization
• Unable to provide informed consent
• Unlikely to survive due to non cardiac issues
• Psychiatric conditions that would interfere with compliance.
• Center for Epidemiologic Studies Depression scale higher than 16 points.
• Those coming to the cardiac rehabilitation program due to congenital heart disease with no risk factors for ischemic heart disease.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Simon Fraser University

OTHER

Sponsor Role: lead

Responsible Party

Alejandra Farias-Godoy

MD, MSc, PhD candidate. Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Lear, PhD

Role: PRINCIPAL_INVESTIGATOR

Simon Fraser University

Alejandra Farias-Godoy, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Simon Fraser University

Locations

St Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

37553

Identifier Type: OTHER

Identifier Source: secondary_id

37553

Identifier Type: -

Identifier Source: org_study_id