Effect of Intradialytic Physical ACTIvity in Addition to a NUTritional Support on Protein Energy Wasting and Physical Functioning in Chronic Hemodialysis Patients ("ACTINUT" Study), Multicenter, Randomized, Controlled Open Label Trial Study Multicenter, Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of patients who correct the state of protein energy wasting in intervention group compared to a control group
研究概览
简要总结
Sedentary behavior and protein-energy wasting (PEW) are well known risk factors of adverse outcome and low quality of life in chronic renal failure patients treated by dialysis. Treatment strategies of PEW by different types of nutritional support (as dietary counseling, oral nutritional supplements or intradialytic parenteral nutrition) have limited efficacy. Physical activity has been shown to have numerous positive impacts in pathologic conditions associated to end stage renal disease.
Concomitant prescription of physical activity and nutritional support might mutually enhance the anabolic effects of these interventions and improve the rate of remission of PEW.
The aim of this study is to analyze the effect of a programmed, progressive endurance training performed during the dialysis session on a cycle ergometer under the supervision of a qualified trainer, on protein energy wasting and physical functioning of chronic hemodialysis patients.
详细描述
Aim 1: To determine the percentage of patients in remission from the state of protein- energy wasting. Hypothesis 1: Patients in the exercise group will more frequently reverse the PEW than in the control group Aim 2: To determine the patterns of change in body composition (fat free mass). Hypothesis 2: Patients in the exercise group will maintain or increase their fat free mass and patients in the control group will decrease their fat free mass Aim 3: To determine the effects of exercise on muscle strength. Hypothesis 3: Patients in the exercise group will maintain or increase their quadriceps strength while patients in the control group will decrease their muscle strength Aim 4: To determine the effects of exercise on postural balance. Hypothesis 4: Patients in the exercise group will maintain or increase their body balance while patients in the control group will decrease their body balance Aim 5: To determine the effects of exercise on quality of life as assessed by the SF-36. Hypothesis 5: Patients in exercise group will maintain or increase their quality of life form while patients in the control group will decrease their quality of life
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 aged >18 years, treated by hemodialysis since more than 3 months
- •Patients considered to be in a clinical stable state, defined as the absence of acute disease or hospitalization during the last month prior to study begin
- •Patients fulfilling the diagnostic criteria of protein energy wasting according to the definition proposed by the International Society of Renal Nutrition and Metabolism (ISRNM)
- •Patients having signed the informed consent for the study participation
- •Patients covered by medical insurance
排除标准
- •Medical contraindication or inability to perform physical exercise
- •Inadequate dialysis (KT/V< 1.2)
- •Poor hemodynamic tolerance of dialysis
- •Systemic inflammation (CRP >20 mg/l)
- •Pregnancy
- •Major trust
结局指标
主要结局
Number of patients who correct the state of protein energy wasting in intervention group compared to a control group
时间窗: at 6 months
次要结局
- Body composition (fat free mass), assessed by bioimpedance spectroscopy using the Body composition monitor (BCM)(at 3 months and at 6 months)
- Quadriceps strength measured by dynamometer(at 3 months and at 6 monts)
- Performance (distance and velocity) in the 6 minute walk test(at 3 months and 6 months)
- Postural balance as measured by a force platform(at 3 months and at 6 months)
- Quality of life as measured by the SF-36 test(at the 3 months and at 6 months)
- The number of hospitalization days(at the 3 months and the 6 months)
- The survival(at the 3 months and at the 6 months)
- The dosage of albumin(at the 3 months and at the 6 months)
- The dosage of prealbumin(at 3 months and 6 months)