Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of physical endurance on bicycle
研究概览
简要总结
The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.
详细描述
The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Hemodialysis patient since at least 6 month
- •Patient aged 18 years or older
- •Written consent to participate in the study
- •No acute infection or hospitalization
- •Opinion of Cardiologist saying there is no known evidence against the evaluation of the maximum exercise capacity
- •Protein-energy wasting diagnosed if at least two of this characteristics are present
- •Serum albumin <3.8 g per 100 ml (Bromcresol Green)
- •Serum prealbumin (transthyretin) <30mg per 100 ml
- •Reduce body mass (BMI <23)
- •Unintentional 10% weight loss over 6 months
- •Lean body mass index < 10th percentile
排除标准
- •Presence of comorbidity which compromising the survival within 6 month
- •Unintentional low DEI <20 kcal kg_1 day_1
- •HIV or HCV positive
- •History of hormone dependent cancer
- •Suspected or confirmed prostate cancer or breast carcinoma
- •Known hypersensitivity for testosterone
- •Presence or history of hepatic tumor
- •Inability to follow the rehabilitation program
- •Inadequate dialysis dosage (<12 hours / week or Kt/V index< 1,2) Pregnant or planning pregnancy and lactating women during study period
- •Adult patient protected by law
- •Patient who don't sign his informed consent
研究组 & 干预措施
treated group
testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
干预措施: training on ergonomic bicycle (Other)
treated group
testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
干预措施: Testosterone (Drug)
treated group
testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
干预措施: Oral nutritional supplementation (Drug)
treated group
testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
干预措施: n3 polyunsaturated fatty acid (Drug)
control group
oral nutritional supplementation
干预措施: Oral nutritional supplementation (Drug)
结局指标
主要结局
Change of physical endurance on bicycle
时间窗: At months 3 and 15 after inclusion
Physical endurance on bicycle at intermediate power between maximal power and ventilatory threshold power (Pmax+Pthreshold)/2
次要结局
- Health-related quality of life assessment using SF-36 scale and KDQOL(at day 1)
- Karnofsky score(at ady 1)
- determination of creatinine(µmol/L)(at 1 year)
- Body composition(at day 1)
- determination of urea (mmol/L)(at day 1)
- Transthyrin serum concentration evolution(at day 1)
- Maximal power on bicycle(at day 1)
- Nutritional parameters(at day 1)
- serum levels of albumin (g/L)(at day 1)