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
  Purpose

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)

Condition Intervention
Chronic Renal Failure (CRF)
Device: electrostimulation program (Rehab 400)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 68
Study Start Date: January 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stimulated group
stimulated group
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
No Intervention: control group
Control group : non stimulated group.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282554

Locations
France
AUB Santé Brest
Brest, Bretagne, France, 29200
AUB Santé Fougères
Fougères, Bretagne, France, 35300
AUB Santé Lorient
Lorient, Bretagne, France, 56100
AUB Santé Montgermont
Montgermont, Bretagne, France, 35760
AUB Santé Morlaix
Morlaix, Bretagne, France, 29600
AUB Santé Quimper
Quimper, Bretagne, France, 29000
Rennes University Hospital
Rennes, Bretagne, France, 35000
AUB Santé Rennes
Rennes, Bretagne, France, 35033
Cholet Hospital
Cholet, France, 49325
Nantes University Hospital
Nantes, France, 44093
ECHO Nantes
Nantes, France, 44821
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Eric Laruelle, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01282554     History of Changes
Other Study ID Numbers: 2010-A01149-30
Study First Received: December 30, 2010
Last Updated: January 3, 2014
Health Authority: France: Institutional Ethical Committee

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014