Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-04-30

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.

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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.

Conditions

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Chronic Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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treated group

testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle

Group Type EXPERIMENTAL

training on ergonomic bicycle

Intervention Type OTHER

Testosterone

Intervention Type DRUG

Oral nutritional supplementation

Intervention Type DRUG

n3 polyunsaturated fatty acid

Intervention Type DRUG

control group

oral nutritional supplementation

Group Type OTHER

Oral nutritional supplementation

Intervention Type DRUG

Interventions

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training on ergonomic bicycle

Intervention Type OTHER

Testosterone

Intervention Type DRUG

Oral nutritional supplementation

Intervention Type DRUG

n3 polyunsaturated fatty acid

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No