Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Kidney Failure

Intervention / Treatment
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* Other: training on ergonomic bicycle
* Drug: Testosterone
* Drug: Oral nutritional supplementation
* Drug: n3 polyunsaturated fatty acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treated group<br>testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle | Other: training on ergonomic bicycle<br> <br> Drug: Testosterone<br> <br> Drug: Oral nutritional supplementation<br> <br> Drug: n3 polyunsaturated fatty acid<br> <br> |
| Other: control group<br>oral nutritional supplementation | Drug: Oral nutritional supplementation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of physical endurance on bicycle | Physical endurance on bicycle at intermediate power between maximal power and ventilatory threshold power (Pmax+Pthreshold)/2 | At months 3 and 15 after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transthyrin serum concentration evolution | (Unit of Measure: g/L) | at day 1 | 
| Health-related quality of life assessment using SF-36 scale and KDQOL |  | at day 1 | 
| Karnofsky score |  | at ady 1 | 
| Maximal power on bicycle | Unit of Measure: Watt | at day 1 | 
| Nutritional parameters | weight (Kg) | at day 1 | 
| serum levels of albumin (g/L) |  | at day 1 | 
| determination of urea (mmol/L) |  | at day 1 | 
| determination of creatinine(µmol/L) |  | at 1 year | 
| Body composition | (evaluated by bioimpedance) | at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical exercises, Oral nutritional supplementation, Multimodal, Hemodialysis, Protein-Energy Wasting