Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

Overview

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.

Full Title of Study: “Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2017

Detailed Description

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.

Interventions

  • Other: training on ergonomic bicycle
  • Drug: Testosterone
  • Drug: Oral nutritional supplementation
  • Drug: n3 polyunsaturated fatty acid

Arms, Groups and Cohorts

  • Experimental: treated group
    • testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
  • Other: control group
    • oral nutritional supplementation

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Collaborator
    • Human Nutrition Research Center Rhône-Alpes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Noël CANO, Principal Investigator, University Hospital, Clermont-Ferrand
  • Overall Contact(s)
    • Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr

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