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Sport improves quality of life and health, decreasing cardiovascular risks and increasing effort tolerance. Chronic renal failure (CRF) induces many clinical and biological complications leading to less effort tolerance (strength and endurance). Renal failure patients got also many cardiovascular risks : sedentarily lifestyle, hypertension (HTA), diabetes, neuropathies, bone disorders, depression and sedentarity due to dialysis sessions. Moreover, dialysis sessions three times a week induce the spiral of deconditioning. In order to counteract this, sport should be encourage in this specific hemodialysis population.
The aim of this study is to evaluate electrostimulation program during dialysis sessions for 3 months. Evaluation will be done using the Test of 6-minute walk (6MWT).
Secondary aims will be evaluated:
The primary outcome is the difference between distances during the 6 minutes walk test before and after the 3 month program between the stimulated and the non stimulated group.
The secondary outcomes will be evaluated by maximum strength developed during the ergometry, limited by symptoms; maximal charge during muscular test; quadricipital diameter; time for the " Timed up and go " test; quality of life scores. All those scores will be evaluated in the control and stimulated groups before and after the 3 month period.
This is an open randomized controlled study. Tests will be done by an investigator unaware of the stimulation group. The study is designed to detect a difference of 61 m (+/- 80 m) (6MWT) before and after stimulation in the stimulated group and 0 in the control group. This difference has been based on a pilot study with ergocycle in the same population and on literature in other populations (chronic respiratory failure or post cardiac surgery). We estimated that 70 patients would need to be enrolled in each group to provide 90% statistical power with a bilateral test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stimulated group | Experimental | stimulated group |
|
| control group | No Intervention | Control group : non stimulated group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrostimulation program (Rehab 400) | Device | electrostimulation program (Rehab 400) : electrostimulation program during dialysis sessions for 3 months. Electrostimulation modalities have been chosen to seek both slow and fast muscle fibers : 35 Hz ; impulsion time: 400 µsec ; on/ off : 7'' contraction / 8'' relaxation. Stimulated muscles are quadriceps. Electrostimulation time will be 30 minutes. Each patient will individually regulate work intensity, maximal intensity should be the maximal tolerable intensity. Electrostimulation will be done 3 times per week. In case of asthenia or medical condition, electrostimulation can be delayed. The program will take place for 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| difference between distances during the 6 minutes walk test before and after the 3 month program between the stimulated and the non stimulated group | The primary outcome is the difference between distances during the 6 minutes walk test before and after the 3 month program between the stimulated and the non stimulated group | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| maximum strength developed during the ergometry, limited by symptoms; maximal charge during muscular test; quadricipital diameter; time for the " Timed up and go " test; quality of life scores. | The secondary outcomes will be evaluated by maximum strength developed during the ergometry, limited by symptoms; maximal charge during muscular test; quadricipital diameter; time for the " Timed up and go " test; quality of life scores. All those scores will be evaluated in the control and stimulated groups before and after the 3 month period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Laruelle, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUB Santé Brest | Brest | Brittany Region | 29200 | France | ||
| AUB Santé Fougères |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22100992 | Result | Besnier F, Laruelle E, Genestier S, Gie S, Vigneau C, Carre F. [Effects of exercise training on ergocycle during hemodialysis in patients with end stage renal disease: relevance of the anaerobic threshold intensity]. Nephrol Ther. 2012 Jul;8(4):231-7. doi: 10.1016/j.nephro.2011.10.002. Epub 2011 Nov 18. French. |
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|
|
| 3 months |
| Fougères |
| Brittany Region |
| 35300 |
| France |
| AUB Santé Lorient | Lorient | Brittany Region | 56100 | France |
| AUB Santé Montgermont | Montgermont | Brittany Region | 35760 | France |
| AUB Santé Morlaix | Morlaix | Brittany Region | 29600 | France |
| AUB Santé Quimper | Quimper | Brittany Region | 29000 | France |
| Rennes University Hospital | Rennes | Brittany Region | 35000 | France |
| AUB Santé Rennes | Rennes | Brittany Region | 35033 | France |
| Cholet Hospital | Cholet | 49325 | France |
| Nantes University Hospital | Nantes | 44093 | France |
| ECHO Nantes | Nantes | 44821 | France |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| 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 |
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