Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)
Overview
- Phase
- Phase 3
- Intervention
- training on ergonomic bicycle
- Conditions
- Chronic Kidney Failure
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change of physical endurance on bicycle
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
treated group
testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
Intervention: training on ergonomic bicycle
treated group
testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
Intervention: Testosterone
treated group
testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
Intervention: Oral nutritional supplementation
treated group
testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
Intervention: n3 polyunsaturated fatty acid
control group
oral nutritional supplementation
Intervention: Oral nutritional supplementation
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- determination of urea (mmol/L)(at day 1)
- Transthyrin serum concentration evolution(at day 1)
- Maximal power on bicycle(at day 1)
- Nutritional parameters(at day 1)
- serum levels of albumin (g/L)(at day 1)