Reduced Cardiac Rehabilitation Program
Condition: Cardiovascular Disease; Obesity; Dyslipidemia
MeSH terms: Cardiovascular Diseases; Dyslipidemias
Study type: Interventional

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?
    

Intervention name(s): Reduced cardiac rehabilitation group intervention (rCRP).; Standard cardiac rehabilitation intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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 intervention name(s): rCRP; sCRP
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cardiac rehabilitation; prevention; exercise capacity