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

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)

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure (CRF)
• Intervention / Treatment: Device: electrostimulation program (Rehab 400)

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cholet, France, 49325
    • Cholet Hospital
  • Nantes, France, 44093
    • Nantes University Hospital
  • Nantes, France, 44821
    • ECHO Nantes
  • Bretagne
    • Brest, Bretagne, France, 29200
      • AUB Santé Brest
    • Fougères, Bretagne, France, 35300
      • AUB Santé Fougères
    • Lorient, Bretagne, France, 56100
      • AUB Santé Lorient
    • Montgermont, Bretagne, France, 35760
      • AUB Santé Montgermont
    • Morlaix, Bretagne, France, 29600
      • AUB Santé Morlaix
    • Quimper, Bretagne, France, 29000
      • AUB Santé Quimper
    • Rennes, Bretagne, France, 35000
      • Rennes University Hospital
    • Rennes, Bretagne, France, 35033
      • AUB Santé Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 Names: electrostimulation
No Intervention: control group; Control group : non stimulated group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	3 months

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Eric Laruelle, MD, Rennes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 30, 2010
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 2010-A01149-30