Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rennes University Hospital
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients, \> 18 y/o, undergoing chronic hemodialysis since more than 3 months.
Physical activity score (Voorrips test) \<9.4
Patients clinically and hemodynamically stable.
No major drug or dialysis treatment changes since 2 weeks
Written consent signed.
You may not be if
Relative or absolute contraindication to ergotest (ACC/AHA, 2002) and/or physical reentrainment.
Incapacity to practice the Test of 6-minute walk (6MWT) or ergotest
Clinical instability during hemodialysis sessions.
Hb\<9g/dl despite medical treatment ; PAS ≥180 mmHg et/ou PAD ≥110 mmHg despite medical treatment ;
Cardiac pace maker or defibrillator ;
Pregnancy ;
Recent cardiovascular events: cardiac failure less than 10 days before, instable angina, coronary angioplasty less than 10 days cardiac surgery less than 1 month, valvulopathy requiring surgery, myopericarditis, severe Rhythm troubles despite medical treatment, stade IV arteriopathy.
BMI ≥ 30 kg/m² ;
Anxiety and mental disorder
Concomitant pathology leading to severe general status alteration.
Patient participating to another medical study
Electromyostimulation or effort entrainment program less than a month.
Patients on renal transplantation awaiting list.
Patient practicing sport ( response to Voorips test)
