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| Name | Class |
|---|---|
| Human Nutrition Research Center Rhône-Alpes | UNKNOWN |
| Société Francophone Nutrition Clinique et Métabolisme | OTHER |
| Nutricia, Inc. | INDUSTRY |
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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treated group | Experimental | testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle |
|
| control group | Other | oral nutritional supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| training on ergonomic bicycle | Other |
| ||
| Testosterone |
| Measure | Description | Time Frame |
|---|---|---|
| Change of physical endurance on bicycle | Physical endurance on bicycle at intermediate power between maximal power and ventilatory threshold power (Pmax+Pthreshold)/2 | At months 3 and 15 after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Transthyrin serum concentration evolution | (Unit of Measure: g/L) | at day 1 |
| Health-related quality of life assessment using SF-36 scale and KDQOL | at day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Noël CANO | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32390133 | Derived | Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2. |
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|
| Oral nutritional supplementation | Drug |
|
| n3 polyunsaturated fatty acid | Drug |
|
| Karnofsky score | at ady 1 |
| Maximal power on bicycle | Unit of Measure: Watt | at day 1 |
| Nutritional parameters | weight (Kg) | at day 1 |
| serum levels of albumin (g/L) | at day 1 |
| determination of urea (mmol/L) | at day 1 |
| determination of creatinine(µmol/L) | at 1 year |
| Body composition | (evaluated by bioimpedance) | at day 1 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D019587 | Dietary Supplements |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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