Compliance, Viability and Effectiveness of Home Based Cardiac Rehabilitation: a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change in adherence on CR sessions
研究概览
简要总结
The proposal of this study is to verify if it is feasible and effective to offer a home based cardiac rehabilitation program, that includes the components of health education and physical exercises mostly unsupervised and oriented by telephone and to compare the treatment adherence, the effects in the functional capacity, and the control of coronary risk factors in relation to the traditional cardiac rehabilitation offered mostly supervised and center based.
详细描述
This study will be developed with patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, provided they are considered of low and moderate risk for the practice of physical exercise of moderate intensity, according to the risk stratification proposed by the American Association of Cardiovascular and Pulmonary Rehabilitation. Volunteers will be recruited at the outpatient at the University Hospital's Cardiac Rehabilitation Centre. The study will be made in conformity with the CONSORT guidelines for non-pharmacological interventions. After being invited to the study, the volunteer whose accept the participation and sign the consent form will be randomized into two different groups: Traditional cardiac rehabilitation (mostly supervised) and Telerehabilitation (mostly unsupervised). The randomization will be made through the www.randomization.com website in blocks of four volunteers each. A blind researcher will evaluate participants before and after test, and will fulfill the database.
Intervention The parameters for the exercise prescription will be the same for both groups. Exercise sessions will be constituted of 5-10 minutes of warm up, 40 minutes of aerobic activity with heart rate between 60 and 80% of the heart rate reserve, and 5-10 minutes of cool down. The educational sessions will be given to both groups in six meetings with 40 minutes each, and items regarding the control of risk factors and treatment of cardiovascular diseases will be approached. After the period of 12 weeks of intervention all participants will be stimulated to continue to practice physical exercises at home or at the community, and they will be invited to a re-evaluation after three months.
Groups:
Traditional cardiac rehabilitation as control group (CentreRehab) The CentreRehab group will be made supervised exercises and health educational activities, personally at cardiac rehabilitation centre. This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week). The participants of this group will be oriented to fulfill a training diary with information regarding the frequency of the exercises, the presence of symptoms, and the use of the scale of perceived exertion during exercises at home.
Home-based cardiac rehabilitation (HomeRehab) The participants of the HomeRehab group will make the exercise mostly at home. There will be weekly phone calls, in person educational sessions, and monthly meetings to check the execution of the previous stage, solve doubts, or identify the presence of symptoms or undesirable effects. This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, or that had a heart attack, provided they are considered of a low and moderate risk for the practice of physical exercise of moderate intensity according to the stratification for the risk of events during a cardiovascular rehabilitation program
- •Clinical stability, according with the medical evaluation;
- •Residents of the Belo Horizonte's metropolitan region.
排除标准
- •Recent cardiac event or clinical decompensation (<1month);
- •Presence of peripheral arterial occlusive disease with limitation degree that prevents the test of maximum exercise (emergence of claudication before the maximum cardiorespiratory fatigue);
- •Presence of chronic pulmonary disease (i.e. Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, and pulmonary arterial hypertension of pre capillary etiology);
- •History of ventricular fibrillation or sustained ventricular tachycardia in the last year;
- •Presence of high risk criteria during the ergometric test;
- •Physical, cognitive, or social limitation that prevent the participation in a physical exercise program, and the comprehension of the use of the monitoring device.
结局指标
主要结局
Change in adherence on CR sessions
时间窗: after 3 and 6 months of the intervention
it will be analyzed by the percentage of participants which completed the minimum of 75% of the sessions
次要结局
- Change in Blood pressure(At baseline, after 3 and 6 months)
- Change in glycated hemoglobin(At baseline, after 3 and 6 months)
- Cost(after 3 and 6 months of the intervention)
- Change in quality of life(At baseline, after 3 and 6 months)
- Change in functional capacity(At baseline, after 3 and 6 months)
- Change in morbidity(after 3 and 6 months of the intervention)
- Change in fasting blood glucose(At baseline, after 3 and 6 months)
- Change in knowledge about coronary artery disease(At baseline, after 3 and 6 months)
- Usability(For TeleRehab group after 3 months of the intervention)
- Change in scores of depression(At baseline, after 3 and 6 months)
- Change in total cholesterol(At baseline, after 3 and 6 months)
- Change in level of physical activity(At baseline, after 3 and 6 months)
- Change in Waist circumference(At baseline, after 3 and 6 months)
研究者
Raquel Rodrigues Britto
Full Professor
Federal University of Minas Gerais