Reduced Cardiac Rehabilitation Program (rCRP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alejandra Farias-Godoy, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT01483235
First received: November 28, 2011
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Obesity
Dyslipidemia
Behavioral: Reduced cardiac rehabilitation group intervention (rCRP).
Behavioral: Standard cardiac rehabilitation intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Design, Implementation and Evaluation of a Reduced Cardiac Rehabilitation Program

Resource links provided by NLM:


Further study details as provided by Simon Fraser University:

Primary Outcome Measures:
  • Exercise Capacity [ Time Frame: Data collection to be completed in September 2011 ] [ Designated as safety issue: No ]
    Exercise capacity will be determined through a symptom-limited maximal treadmill exercise test using the Bruce protocol and reported as total time in seconds in the treadmill. Participants will undergo continuous 12-lead ECG monitoring during the test. Participants will have their baseline, exit(program completion) and one-year (16 to 20 months from baseline) exercise stress tests conducted at the ECG stress laboratory at St. Paul's Hospital.


Secondary Outcome Measures:
  • Metabolic risk factors. [ Time Frame: Data collection to be completed by September 2011 ] [ Designated as safety issue: No ]
    Total cholesterol, HDL-C, triglycerides and blood glucose will be assessed from fasting blood samples. The Friedewald equation will be used to calculate LDL-C. To assess for change in global risk score, the Framingham risk score and the Progression of Disease risk score will be used for primary and secondary prevention patients respectively. Blood pressure will be measured with a manual sphyngomanometer. These outcomes will be assessed at baseline (program intake), program completion (four to six months from baseline) and at 16 to 20 months from baseline.

  • Lifestyle [ Time Frame: Data collection to be completed in September 2011 ] [ Designated as safety issue: No ]
    Leisure time physical activity will be determined by the four-week modified Minnesota LTPA questionnaire and reported as the average weekly kilocalories (kcal/wk) expended through physical activity and exercise. Diet will be reported as percent daily kilocalories for fat, protein and carbohydrates using a three-day food record. Smoking status will be assessed by self-report. These outcomes will be measured at baseline (program intake), program completion (four to six months from baseline) and at 16 to 20 months from baseline.

  • Psychosocial measures [ Time Frame: Data to be collected by September 2011 ] [ Designated as safety issue: No ]
    Health related Quality of life will be assessed by the Euro Quality of Life questionnaire. Self-efficacy will be assessed with the self-efficacy questionnaire that has two components: a general self-efficacy assessment and exercise-specific assessment. These outcomes will be measured at baseline (program intake), program completion (four to six months from baseline)and at 16 to 20 months from baseline.

  • Anthropometry [ Time Frame: Data to be collected by September 2011 ] [ Designated as safety issue: No ]
    Body mass index will be calculated from weight in kilograms divided by height in metres squared. Waist circumference will be recorded in centimetres, taken at the point of maximal narrowing following a normal expiration. Hip circumference will be recorded in centimetres taken at the point of maximal gluteal protuberance. Waist to hip ratio will be calculated by simple division. These outcomes will be measured at baseline (program intake), program completion (four to six months from baseline) and at 16 to 20 months from baseline.

  • Program adherence [ Time Frame: Data collection to be completed in September 2011 ] [ Designated as safety issue: No ]
    Assessed as percent attendance to in-hospital sessions. Overall physical activity adherence will be assessed with the LTPA questionnaire measured as weekly kilocalorie/week expended. This outcome will be measured at baseline (program intake), at program completion (four to six months from baseline)and at 16 to 20 months from baseline.


Enrollment: 118
Study Start Date: September 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
Other Name: rCRP
Active Comparator: 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.
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.
Other Name: sCRP

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

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483235

Locations
Canada, British Columbia
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
Simon Fraser University
Investigators
Principal Investigator: Scott Lear, PhD Simon Fraser University
Principal Investigator: Alejandra Farias-Godoy, MD, MSc Simon Fraser University
  More Information

No publications provided

Responsible Party: Alejandra Farias-Godoy, MD, MSc, PhD candidate. Principal Investigator, Simon Fraser University
ClinicalTrials.gov Identifier: NCT01483235     History of Changes
Other Study ID Numbers: 37553, 37553
Study First Received: November 28, 2011
Last Updated: December 1, 2011
Health Authority: Canada: Health Canada

Keywords provided by Simon Fraser University:
cardiac rehabilitation
prevention
exercise capacity

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 26, 2014