EXerCise Introduction To Enhance Performance in Dialysis: the EXCITE Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test
研究概览
简要总结
To evaluate if a model of intervention based on a low-grade physical program prescribed in the dialysis centre and performed at home can modify the functional capacity and quality of life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular events and vascular access failure in dialysis patients.
详细描述
Background Dialysis patients show an exceedingly higher risk of death and cardiovascular complications (1). These patients are also characterized by poor physical performance and reduced quality of life. Observational findings in the United States Renal Data System (USRDS) indicated that physical rehabilitation programs after coronary artery bypass are associated with better clinical outcomes in this population (2). However, the hypothesis that physical training in dialysis patients may translate into better physical performance and clinical outcomes has never been tested in large randomized clinical trials. In studies performed so far, physical exercise was proposed during the dialysis session or between two dialysis sessions. These programs imply compliance, organization and cost problems, mainly related with intensification of visit to the dialysis centre. To limit these difficulties, a single easy-to-implement program of physical exercise for dialysis patients, prescribed in the dialysis centre but performed at home, has been recently elaborated and a pilot study has shown that this program improves physical performance in medium term (3).
Purpose This clinical trial tests whether a physical program prescribed in the dialysis centre but performed at home improves the degree of fitness and the quality of life in dialysis patients.
Study population
-
Inclusion Criteria:
-
500 Patients on dialysis
-
Dialysis vintage>6 months
-
Age>18 years
-
Signed informed consent
-
Stable clinical conditions
-
Exclusion Criteria:
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
- •Patients on dialysis
- •Dialysis vintage>6 mo.
- •Age>18 aa.
- •Signed informed consent
- •Stable clinical conditions
排除标准
- •any physical or clinical limitations to deambulation
结局指标
主要结局
Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test
时间窗: 6 months
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary
时间窗: 6 months
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
次要结局
- Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival.(6 months)
- All - causes and cardiovascular hospitalizations(6 months)
研究者
Carmine Zoccali
prof.
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy