Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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