Chronic Kidney Failure
Conditions
Keywords
Physical exercises, Oral nutritional supplementation, Multimodal, Hemodialysis, Protein-Energy Wasting
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.
Interventions
OTHERtraining on ergonomic bicycle
DRUGTestosterone
DRUGn3 polyunsaturated fatty acid
Sponsors
Human Nutrition Research Center Rhône-Alpes
Société Francophone Nutrition Clinique et Métabolisme
Nutricia, Inc.
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life assessment using SF-36 scale and KDQOL | at day 1 | — |
| Karnofsky score | at ady 1 | — |
| Maximal power on bicycle | at day 1 | Unit of Measure: Watt |
| Nutritional parameters | at day 1 | weight (Kg) |
| Transthyrin serum concentration evolution | at day 1 | (Unit of Measure: g/L) |
| determination of urea (mmol/L) | at day 1 | — |
| determination of creatinine(µmol/L) | at 1 year | — |
| Body composition | at day 1 | (evaluated by bioimpedance) |
| serum levels of albumin (g/L) | at day 1 | — |
Countries
France
Contacts
Primary ContactPatrick LACARIN
Outcome results
None listed