Reduced Cardiac Rehabilitation Program

NCT01483235 | Completed

• 1 other identifier: 37553
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Obesity; Dyslipidemia

Keywords

cardiac rehabilitation; prevention; exercise capacity

Outcome Measures

Primary Outcomes (1)

• Exercise Capacity

  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.

  Data collection to be completed in September 2011

Secondary Outcomes (5)

• Metabolic risk factors.

  Data collection to be completed by September 2011

• Lifestyle

  Data collection to be completed in September 2011

• Psychosocial measures

  Data to be collected by September 2011

• Anthropometry

  Data to be collected by September 2011

• Program adherence

  Data collection to be completed in September 2011

Study Arms (2)

Reduced cardiac rehabilitation (rCRP)

EXPERIMENTAL

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).

Standard cardiac rehabilitation (sCRP)

ACTIVE COMPARATOR

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

Interventions

Reduced cardiac rehabilitation group intervention (rCRP). 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.

Also known as: rCRP

Reduced cardiac rehabilitation (rCRP)

Standard cardiac rehabilitation intervention 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.

Also known as: sCRP

Standard cardiac rehabilitation (sCRP)

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Simon Fraser University: lead

Study Sites (1)

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity; Dyslipidemias

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Scott Lear, PhD

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

• Alejandra Farias-Godoy, MD, MSc

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD candidate. Principal Investigator

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 1, 2011
• Study Start: September 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 2, 2011

Record last verified: 2011-12

Locations

CA (1)