Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients

NCT01282554 | Completed

• 1 other identifier: 2010-A01149-30
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 11

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)

Conditions

Chronic Renal Failure (CRF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  3 months

Study Arms (2)

stimulated group

EXPERIMENTAL

stimulated group

Device: electrostimulation program (Rehab 400)

control group

NO INTERVENTION

Control group : non stimulated group.

Interventions

electrostimulation program (Rehab 400) DEVICE

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.

Also known as: electrostimulation

stimulated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (11)

AUB Santé Brest

Brest, Brittany Region, 29200, France

Location

AUB Santé Fougères

Fougères, Brittany Region, 35300, France

Location

AUB Santé Lorient

Lorient, Brittany Region, 56100, France

Location

AUB Santé Montgermont

Montgermont, Brittany Region, 35760, France

Location

AUB Santé Morlaix

Morlaix, Brittany Region, 29600, France

Location

AUB Santé Quimper

Quimper, Brittany Region, 29000, France

Location

Rennes University Hospital

Rennes, Brittany Region, 35000, France

Location

AUB Santé Rennes

Rennes, Brittany Region, 35033, France

Location

Cholet Hospital

Cholet, 49325, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

ECHO Nantes

Nantes, 44821, France

Location

Related Publications (1)

• 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.

  PMID: 22100992 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Laruelle, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: January 25, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (11)