Chronic Intradialytic Exercise: a Cardioprotective Role
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Changes in myocardial longitudinal deformations
研究概览
简要总结
The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function.
详细描述
Background: Hemodialysis patients have a mortality rate 50 times higher than in the general population, and the cause remains cardiovascular in more than half of the cases. A deleterious morphological and functional cardiac remodelling is well established in these patients, the causes of which are both the presence of factors specific to renal disease (hemodynamic and non-hemodynamic) and co-morbidities (diabetes, hypertension, etc. .) but also to the hemodialysis (HD) procedure itself, due to the sudden hemodynamic changes it imposes, leading to repeated episodes of intradialytic hypotension (HID) and myocardial stunning. The latter are now documented as direct contributors to the increased mortality observed in HD patients compared to the general population. The introduction of intradialytic physical exercise in the therapeutic program of HD patient is now recommended and practised routinely in many countries, in Scandinavia in particular. Several meta-analyses have clearly established its safety. The beneficial role of chronic intradialytic exercise in improving dialysis efficiency, mental health and quality of life, as well as the inflammatory status of HD patients is also clearly demonstrated. Chronic intradialytic exercise is also associated with improvements in overall fitness level, a parameter closely linked to cardiovascular mortality. Applied acutely during dialysis, it could play a cardioprotective role (e.g; limiting myocardial stunning), allowing haemodynamic and cardiac functional stabilization during HD. However, to our knowledge, no study to date has investigated the long-term effects of intradialytic exercise on remodelling and overall and regional heart function.
Aims: The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function. The secondary objectives are to evaluate the effect of acute intradialytic exercise on myocardial stunning as well as the effect of chronic physical exercise on macro and microcirculatory vascular function, inflammation, physical fitness and health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No medical contraindication to physical activity
- •Life expectancy greater than 6 months
- •Patients on haemodialysis for more than 3 months
排除标准
- •Pregnancy
- •Valvular heart disease,
- •Unstable coronary artery disease
- •Arteriopathy obliterating of the lower limbs stage III and IV
- •Musculoskeletal problems
- •Severe respiratory disease
- •Pacemaker, cardiac stimulation and automatic implantable defibrillator
- •Heart transplant
- •Uncontrolled arterial hypertension
- •Ejection fraction <45%
结局指标
主要结局
Changes in myocardial longitudinal deformations
时间窗: Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).
Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Changes in myocardial circumferential deformations
时间窗: Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).
Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Changes in left ventricular torsion
时间窗: Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).
Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.
次要结局
- Changes in carotid intimal-media wall thickness(before (week 0) and after (week 17) an exercise training program of 16 weeks)
- Changes in arterial rigidity(before (week 0) and after (week 17) an exercise training program of 16 weeks)
- Health-related Quality of life(before (week 0) and after (week 17) an exercise training program of 16 weeks)
- Changes in Physical fitness(before (week 0) and after (week 17) an exercise training program of 16 weeks)