Clinical trial NCT01483235: Reduced Cardiac Rehabilitation Program
Official title: Design, Implementation and Evaluation of a Reduced Cardiac Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Obesity
Dyslipidemia
Keywords: cardiac rehabilitation
prevention
exercise capacity
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 118
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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?

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.

Primary outcomes:
measure: Exercise Capacity
timeFrame: Data collection to be completed in September 2011
Secondary outcomes:
measure: Metabolic risk factors.
timeFrame: Data collection to be completed by September 2011
measure: Lifestyle
timeFrame: Data collection to be completed in September 2011
measure: Psychosocial measures
timeFrame: Data to be collected by September 2011
measure: Anthropometry
timeFrame: Data to be collected by September 2011
measure: Program adherence
timeFrame: Data collection to be completed in September 2011
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
Study officials:
affiliation: Simon Fraser University
name: Scott Lear, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Simon Fraser University
name: Alejandra Farias-Godoy, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: