Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Physical Fitness
研究概览
简要总结
Physical exercise training appears effective for low to moderate patients assigned to cardiac rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity levels often drop after attending the last supervised rehabilitation session.
This study will compare home based physical exercise training including telemonitoring with regular centre based physical exercise training. Main outcome measures are the change in physical activity and the change in physical fitness (peak Oxygen uptake) after the initial rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are cost-effectiveness, training adherence, health-related quality of life and patient satisfaction.
详细描述
Physical training has beneficial effects on exercise capacity, cardiac function, quality of life and mortality in patients with acute cardiovascular syndrome or after cardiac surgery and is therefore one of the main aspects of cardiac rehabilitation. However, adherence to this therapy is low and effects tempt to decrease directly after the treatment period.
The objective of this study is to compare the effects of home-based exercise training (HT) with telemonitoring guidance and regular centre-based exercise training (CT) on physical fitness (PF), assessed by peak oxygen uptake, and physical activity (PA), assessed by physical activity energy expenditure (PAEE), in low to moderate risk cardiac rehabilitation (CR) patients. Secondary endpoints are cost-effectiveness, training adherence, health-related quality of life (QoL) and patient satisfaction.
Single-centre randomized controlled trial. CR patients are randomized to HT (n=45) or CT (n=45). Assessments are performed at baseline, 12 weeks and 1 year, consisting of maximal exercise testing with respiratory gas exchange analysis, assessment of PAEE, QoL (also at 6 months), patient satisfaction (at 12 weeks only) and health care costs (12 weeks, 6 months and 1 year) Study population: Low to moderate risk patients entering outpatient CR after an acute coronary syndrome or revascularization with internet access and PC at home.
12-week training program (24-36 one-hour sessions) at 70-85% of their maximal heart rate (HR). In the CT group training is supervised by a physical therapist; in the HT group training is performed in the home environment using a HR monitor to determine training intensity and with weekly feedback / motivation by an exercise specialist who has access to the online HR-data. After 12 weeks, subjects in the HT group are encouraged to continue using the HR monitor.
Main study parameters/endpoints: Primary endpoints: PF (peak oxygen uptake) and PA (physical activity energy expenditure, PAEE) assessed by a tri-axial accelerometer and HR monitor. Secondary endpoints: training adherence, QoL (SF-36) and patient satisfaction (CQ index).
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ACS (including non ST and ST elevation myocardial infarction and unstable angina) or a cardiac revascularization procedure (PCI or CABG) entering outpatient CR at Maxima Medical Center.
- •Indication for exercise training according to the Dutch clinical algorithm for assessment of patient needs in cardiac rehabilitation.
- •Internet access and PC at home (i.e. more than 90 percent of the Dutch household)
排除标准
- •High risk according to the Dutch CR practice guideline.
- •Systolic heart failure (left ventricular ejection fraction of more than 40 percent.
- •New York Heart Association class III-IV (i.e. breathlessness during light exercise or at rest).
- •Severe arrhythmia.
- •Hemodynamically significant valvular disease.
- •Implantable cardioverter-defibrillator (ICD) implantation
- •Heart transplantation.
- •Chronic angina or silent ischemia.
- •Comorbidity impairing exercise capacity (e.g. COPD, diabetes mellitus, peripheral vascular disease and orthopedic or neurological conditions).
- •Severe psychological or cognitive impairments.
结局指标
主要结局
Physical Fitness
时间窗: Measured after 12 weeks and after one year
Changes in peak oxygen uptake (VO2max) in mL O2/kg/min
Physical Activity Level (PAL)
时间窗: measured after 12 weeks and after one year
PAL is calculated by combining data from an accelerometer with data from a heart monitor, after wearing both for five days continuously. To determine PAL, physical activity energy expenditure is divided by resting metabolic rate, calculated by the Harris-Benedict equation. PAL expressed a person's daily energy expenditure. When PAL is used to classify the intensity of an activity, PAL\<3, PAL\<6 and PAL\>6 are characterized as light, moderate and vigorous intensity activities respectively. An average daily PAL of 1.2 represents the activity level of a bed-bound subject, while the average PAL for the adult population is 1.7.
次要结局
- Health Related Quality of Life(measured at baseline, at discharge (12 weeks), and follow-up (one year))
- Patient Satisfaction(Measured at CR discharge (12 weeks))
- Training Adherence(12 weeks)
研究者
H.Kemps
MD, PhD
Maxima Medical Center