Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients (EMS-Dialyse)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01282554
First received: December 30, 2010
Last updated: January 3, 2014
Last verified: January 2014

December 30, 2010
January 3, 2014
January 2011
May 2013   (final data collection date for primary outcome measure)
difference between distances during the 6 minutes walk test before and after the 3 month program between the stimulated and the non stimulated group [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01282554 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients
Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients

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:

  • Muscular strength and quadriceps diameter
  • Equilibrium
  • Quality of life.
  • Strength developed during maximal exercise test in a subgroup (patient undergoing dialysis in Rennes center, about 40% of the total population)
  • Nutritional intakes (quantitative and qualitative evaluation)

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Renal Failure (CRF)
Device: electrostimulation program (Rehab 400)

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.

Other Name: electrostimulation
  • Experimental: stimulated group
    stimulated group
    Intervention: Device: electrostimulation program (Rehab 400)
  • No Intervention: control group
    Control group : non stimulated group.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01282554
2010-A01149-30
No
Rennes University Hospital
Rennes University Hospital
Not Provided
Principal Investigator: Eric Laruelle, MD Rennes University Hospital
Rennes University Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP