Maintain. A Randomized Trial of Effect of Low-Cost Maintenance Training on Exercise Capacity, Quality of Life and Morbidity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Primary endpoint: Exercise capacity based on standardised cycle ergometer test after 14 months.
研究概览
简要总结
The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure.
详细描述
Guidelines recommend physical training in the treatment of patients with CHF. Several studies have demonstrated that even short-term training programmes can increase maximal oxygen intake, improve muscular strength, reduce neurohumoral activity and result in other effects, which are of potential benefit. Following 2-3 months training at 70 - 80% of maximal capacity, improved exercise capacity and oxygen uptake due to increased cardiac output and also better oxygen uptake in the peripheral muscles have been demonstrated. Moreover, studies have indicated an improvement of the quality of life (QOL). However, the effects of exercise training are rapidly lost without maintenance. Thus the crucial question is to identify a method to sustain the physical activity outside an expensive, enthusiastic and highly motivating protocol.
The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure.
Comparison:
Patients fulfilling specified criteria for Chronic Heart Failure are randomised to either eight weeks with supervised group-based training (1.5 hrs.) twice a week followed by home-based training according to a specified protocol with supervised group-based training every 2 weeks (1,5 hrs), or to eight weeks with supervised training followed by usual care. During the whole period patients in both groups can contact the Heart Failure Clinic when needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ejection Fraction ≤45% assessed by echocardiography within the last 6 months
- •Optimal medical treatment according to guidelines
- •Informed consent -
排除标准
- •Hæmodynamically significant obstructive heart valve disease
- •Hæmodynamically significant valve insufficiency
- •Recent Myocardial infarction (8 weeks)
- •Significant arrythmia at exercise testing (NSVT, VT, VF or SVT with ventricular action >150)
- •Significant ischaemia or angina at low strain(£ 50 W)
- •Disabilities that render physical training impossible
- •Serious other illness with expected shortened survival
- •Participation in other scientific protocols that do not allow participation
- •Lack of informed consent
- •If the patient cannot train in a team supervised by only one physiotherapist, e.g. due to poor balance, the patient can be excluded within the first two weeks of inclusion.
结局指标
主要结局
Primary endpoint: Exercise capacity based on standardised cycle ergometer test after 14 months.
次要结局
- Secondary endpoints:
- Maximum oxygen uptake at 14 months
- Maximum exercise capacity measured by the Shuttle Walk test at 14 months
- Exercise capacity measured by 6-minute walking test (6MWT)at 14 months
- Muscular strength (sit-to-stand) at 14 months
- QOL (SF36 and Minnesota) at 14 months
- Serological tests including brain natriuretic peptide at 14 months
- In a subgroup including 2x20 patients training-induced changes in muscle biopsies will be evaluated at 14 months.
- After 1,3 and 5 years hospital-admissions and death through record linkage.