NCT04831021Unknown不适用
Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in regional myocardial function and myocardial stunning
研究概览
简要总结
This study aims at evaluating, in chronic kidney disease patients on dialysis, the effect of acute per- or pre-dialytic physical exercise on regional myocardial function and myocardial stunning, blood viscosity, arterial stiffness, variability of sinus rhythm, dialysis efficacy, inflammation, mineral and bone disorders, myokines and cardiac remodeling markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patient aged ≥ 20 to ≤ 79 years
- •Undernourished patient according to the ARNOS score : ≥ 2
- •No medical contraindication to physical activity
- •Life expectancy greater than 6 months
- •Patient on hemodialysis for more than 3 months
- •Patients with relatively good echogenicity
排除标准
- •Patient is participating in another Category I interventional study, or has participated in another interventional study within the past 3 months
- •The patient is in an exclusion period determined by a previous study
- •The patient is under legal protection or under guardianship or curatorship
- •It turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent
- •Pregnant, parturient or breastfeeding patient
- •Patient with a contraindication to retraining
- •Patient with valvular heart disease, arteriopathy of the lower limbs stage III and IV, amputation or knee or hip prosthesis
- •Patient with musculoskeletal problems
- •Patient with severe respiratory failure
- •Paired sleep apnea syndrome
- •Patient with automatic implantable defibrillator
- •Heart transplant
- •Uncontrolled high blood pressure
- •Ejection fraction <45%
- •Unstabilized coronaries
- •Non-contributory stress ultrasound
研究组 & 干预措施
Patients issued from dialysis units (clinic)
Experimental
干预措施: Dialysis without physical exercise (Procedure)
Patients issued from dialysis units (clinic)
Experimental
干预措施: Dialysis with pre-dialytic physical exercise (Procedure)
Patients issued from dialysis units (clinic)
Experimental
干预措施: Dialysis with per-dialytic physical exercise (Procedure)
结局指标
主要结局
Change in regional myocardial function and myocardial stunning
时间窗: Weekly over a period of 3 weeks
次要结局
- Change in mineral and bone metabolism markers(Weekly over a period of 3 weeks)
- Change in blood viscosity(Weekly over a period of 3 weeks)
- Change in arterial stiffness(Weekly over a period of 3 weeks)
- Change in dialysis efficacy(Weekly over a period of 3 weeks)
- Change in inflammatory markers(Weekly over a period of 3 weeks)
- Change in myokines(Weekly over a period of 3 weeks)
- Change in cardiac remodeling markers(Weekly over a period of 3 weeks)
- Change in sinus rhythm(Weekly over a period of 3 weeks)
研究者
研究点 (2)
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