Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

Phase 3

• Conditions: Chronic Kidney Failure
• Interventions: Other: training on ergonomic bicycle; Drug: Testosterone; Drug: Oral nutritional supplementation; Drug: n3 polyunsaturated fatty acid

• Registration Number: NCT02418065
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29
• Primary Completion: 2017-03
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treated group	training on ergonomic bicycle	testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
treated group	Oral nutritional supplementation	testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
treated group	n3 polyunsaturated fatty acid	testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
control group	Oral nutritional supplementation	oral nutritional supplementation
treated group	Testosterone	testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle

Primary Outcome Measures

Name	Time	Method
Change of physical endurance on bicycle	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 Outcome Measures

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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France