Rehabilitation in the Form of Exercise Training in Aortic Stenosis Patients (RASP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in peak oxygen uptake
研究概览
简要总结
SURVEY OF THE FIELD Aortic stenosis (AS) is the most common valve disease and increasing due to a growing elderly population. The therapy is aortic valve replacement (AVR). Studies on postoperative rehabilitation of AS pts are scarce. In the few studies available, a mix of valve diseases is presented without considering the differences in pathophysiology and the training regimes are not clearly described.
PURPOSE, AIMS & HYPOTHESIS The investigators purpose is to evaluate whether a supervised cardiac rehabilitation program improves the objective physical capacity and quality of life (QoL) of patients after AVR due to AS, and compare this to patients training by their own. The investigators hypothesize that supervised exercise training may be a more efficient way of rehabilitating these patients.
DESIGN This is a controlled randomized clinical trial comparing 12 weeks of supervised exercise training 3 times per week to home-based training based upon public health recommendations of minimum level of physical activity.
SIGNIFICANCE & IMPLEMENTATION Positive results would support that an organized program of exercise training improves physical capacity and QoL in AS patients following AVR with potential benefit for both patients and society.
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
- 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
- •Elective surgery with aortic valve replacement for aortic stenosis at the thoracic surgery department at Linköping University hospital, Linköping.
- •Geographical residence no further from hospital than permitting visit to Supervised Exercise Training 3 times per week
排除标准
- •Any concommitant heart disease
- •Other surgical intervention at time of valve replacement
- •Age under 18 years
- •Symptomatic lung disease
- •Any disability or disease hampering participation in exercise training
- •Cannot communicate with spoken Swedish
研究组 & 干预措施
Supervised Exercise Training
12 weeks of 40 min aerobic bicycle ergometer exercise 3 times per week.
干预措施: Aerobic Exercise Training (Other)
Physical Activity Recommendations
Written and verbal information on minimal level of physical activity recommended.
干预措施: Physical Activity Recommendations (Other)
结局指标
主要结局
Change in peak oxygen uptake
时间窗: Before (within one week before intervention), 1 week after and 12 months after intervention
Physical capacity measured with cardiopulmonary exercise testing (CPET) on bicycle ergometer.
次要结局
- Change in Health-related Quality of Life(Before (within one week before intervention), 1 week after and 12 months after intervention)
- Change in Physical activity level(Before (within one week before intervention), 1 week after and 12 months after intervention)
- Change in hs-CRP(Before (within one week before intervention), 1 week after and 12 months after intervention)
- Change in NT-pro-BNP(Before (within one week before intervention), 1 week after and 12 months after intervention)
研究者
Kristofer Hedman
Principal Investigator, BSc, Physiotherapist, PhD-student
Linkoeping University