Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)
- Conditions
- Chronic Kidney Failure
- Interventions
- Other: training on ergonomic bicycleDrug: Oral nutritional supplementationDrug: 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- 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 Karnofsky score at ady 1 determination of creatinine(µmol/L) at 1 year 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)
serum levels of albumin (g/L) at day 1
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France