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

Primary Purpose

Chronic Renal Failure (CRF)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electrostimulation program (Rehab 400)
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure (CRF)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • AUB Santé Brest
  • AUB Santé Fougères
  • AUB Santé Lorient
  • AUB Santé Montgermont
  • AUB Santé Morlaix
  • AUB Santé Quimper
  • Rennes University Hospital
  • AUB Santé Rennes
  • Cholet Hospital
  • Nantes University Hospital
  • ECHO Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

stimulated group

control group

Arm Description

stimulated group

Control group : non stimulated group.

Outcomes

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
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.
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.

Full Information

First Posted
December 30, 2010
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01282554
Brief Title
Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients
Acronym
EMS-Dialyse
Official Title
Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure (CRF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stimulated group
Arm Type
Experimental
Arm Description
stimulated group
Arm Title
control group
Arm Type
No Intervention
Arm Description
Control group : non stimulated group.
Intervention Type
Device
Intervention Name(s)
electrostimulation program (Rehab 400)
Other Intervention Name(s)
electrostimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
difference between distances during the 6 minutes walk test before and after the 3 month program between the stimulated and the non stimulated group
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Laruelle, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AUB Santé Brest
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Name
AUB Santé Fougères
City
Fougères
State/Province
Bretagne
ZIP/Postal Code
35300
Country
France
Facility Name
AUB Santé Lorient
City
Lorient
State/Province
Bretagne
ZIP/Postal Code
56100
Country
France
Facility Name
AUB Santé Montgermont
City
Montgermont
State/Province
Bretagne
ZIP/Postal Code
35760
Country
France
Facility Name
AUB Santé Morlaix
City
Morlaix
State/Province
Bretagne
ZIP/Postal Code
29600
Country
France
Facility Name
AUB Santé Quimper
City
Quimper
State/Province
Bretagne
ZIP/Postal Code
29000
Country
France
Facility Name
Rennes University Hospital
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
Facility Name
AUB Santé Rennes
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35033
Country
France
Facility Name
Cholet Hospital
City
Cholet
ZIP/Postal Code
49325
Country
France
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
ECHO Nantes
City
Nantes
ZIP/Postal Code
44821
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22100992
Citation
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.
Results Reference
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Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients

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