Individuell Dosiertes Kraft-ausdauer-training in Ambulanten Herzgruppen - Einfluss Auf Koerperliche Belastbarkeit Von Herzpatienten.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from baseline in maximal exercise capacity (watt/kgBW)
研究概览
简要总结
Seventy patients in cardiac rehabilitation with maximal exercise capacity less than 1.4 watt per kilogram bodyweight will be randomized 1:1 into either an intervention training (IN) group or usual care (UC). The IN patients will perform supervised endurance and resistance exercise for approximately 90 minutes once a week and traditional cardiac rehabilitation (TCR) once a week; the UC patients will perform TCR twice a week. The intervention is planned for six months with a follow-up of a further six months. The primary investigation is differences between IN and UC with regard to changes in exercise capacity (max watt/kgBW).
详细描述
The DOPPELHERZ (The influence of individualized resistance-endurance exercise training on maximal power output in outpatient cardiac rehabilitation) randomized controlled trial was performed at the Department of Prevention and Sports Medicine, Klinikum rechts der Isar in Munich, Germany. 70 patients eligible for and/or participating in cardiac rehabilitation were randomized to six months in an individualized combined exercise group (ICE) or group- based cardiac rehabilitation (GCR), considered usual care in this patient population.
All patients gave written informed consent, the study protocol was approved by the local university hospital ethics committee, all procedures were conducted according to the Declaration of Helsinki.
Participants: All patients were American Heart Association Class "C" (moderate to high risk) based on the presence of cardiac disease and maximal power output of <5 METs (corresponding to <1.4 W/kg body weight), who met eligibility criteria for CR at the time of recruitment. Patients with decompensated or highly symptomatic (NYHA IV) heart failure, acute illness or injury, cardiac hospitalizations within six weeks of inclusion, drug abuse, unstable blood pressure or arrhythmias, high grade valve stenosis or instable diabetes mellitus were excluded.
Primary endpoint: The primary endpoint was change in maximal relative power output (W/kg) measured by CPX after six months.
Exercise training program In both the intervention and usual care arms of the study, exercise training was prescribed twice weekly over a period of six months, and all exercise sessions were led by certified exercise instructors and monitored by physicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participation in cardiac rehabilitation
- •written consent
- •< 1.4 watt/kgBW exercise capacity not more than 12 weeks before study begin
排除标准
- •>= 1.4 watt/kgBW
- •contraindications to exercise participation
- •hospitalized for CVD within six weeks of inclusion
- •acute illness/injury (e.g. fever)
- •chronic drug abuse
- •inability to understand study instructions
- •unwillingness to participate
结局指标
主要结局
Change from baseline in maximal exercise capacity (watt/kgBW)
时间窗: six months
次要结局
- Change from baseline in maximal exercise capacity (watt/kgBW)(12 months)
- Change from baseline in Health Relates Quality of Life (HRQoL as measured by questionnaires)(six and 12 months)
- Number of patients with adverse events (AE; documented)(six and 12 months)
- Change in clinical symptoms (NYHA-stage, CCS-stage, number, type and dose of medications))(six and 12 months)
- Change in physical activity level (based on 7-day accelerometry)(six and 12 months)
- Change from baseline in upper and lower body muscular strength (1RM; kg)(six and 12 months)
- Change from baseline in blood pressure (Systolic and Dystolic;mmHg)(6 and 12 months)
- Change from baseline in anthropometric measures(six and 12 months)