Design, Implementation and Evaluation of a Reduced Cardiac Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Exercise Capacity
研究概览
简要总结
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.
详细描述
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:
- 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)?
- Will the reduced cardiac rehabilitation program have better adherence than the standard cardiac rehabilitation program?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Exercise Capacity
时间窗: Data collection to be completed in September 2011
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.
次要结局
- Metabolic risk factors.(Data collection to be completed by September 2011)
- Psychosocial measures(Data to be collected by September 2011)
- Lifestyle(Data collection to be completed in September 2011)
- Anthropometry(Data to be collected by September 2011)
- Program adherence(Data collection to be completed in September 2011)
研究者
Alejandra Farias-Godoy
MD, MSc, PhD candidate. Principal Investigator
Simon Fraser University