Chronic Renal Failure (CRF)EMS-DialyseNCT01282554
Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients
A study testing electrostimulation program (Rehab 400) in people with Chronic Renal Failure (CRF), run by Rennes University Hospital at 11 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure (CRF)
- What is being tested?
- electrostimulation program (Rehab 400)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 11 sitesFrance
- Study dates
- Jan 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ;
Show all 14Show fewer
- 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)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
AUB Santé Brest
Brest, Brittany Region, 29200
Cholet Hospital
Cholet, 49325
AUB Santé Fougères
Fougères, Brittany Region, 35300
AUB Santé Lorient
Lorient, Brittany Region, 56100
AUB Santé Montgermont
Montgermont, Brittany Region, 35760
AUB Santé Morlaix
Morlaix, Brittany Region, 29600
Nantes University Hospital
Nantes, 44093
ECHO Nantes
Nantes, 44821
AUB Santé Quimper
Quimper, Brittany Region, 29000
Rennes University Hospital
Rennes, Brittany Region, 35000
AUB Santé Rennes
Rennes, Brittany Region, 35033
About this study
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).
Read more
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)
Read the 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.
- Conditions
- Chronic Renal Failure (CRF)
- Being tested
- electrostimulation program (Rehab 400)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrostimulation program (Rehab 400)Device
Also called electrostimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| stimulated group | Experimental | stimulated group Receives: Device: electrostimulation program (Rehab 400) |
| control group | No intervention | Control group : non stimulated group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal Failure (CRF)Studies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Laruelle, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282554
- Sponsor's protocol ID
- 2010-A01149-30
- Acronym
- EMS-Dialyse
- Status last verified
- May 2023
- First submitted
- 30 Dec 2010
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22100992
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients
- ClinicalTrials.gov ID
- NCT01282554
- Acronym / sponsor ID
- EMS-Dialyse / 2010-A01149-30
- Conditions
- Chronic Renal Failure (CRF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulated group | Experimental | Device: electrostimulation program (Rehab 400)stimulated group |
| control group | No intervention | –Control group : non stimulated group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrostimulation program (Rehab 400)Also: electrostimulationelectrostimulation 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. | Device | stimulated group |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 22100992Besnier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Laruelle, MD principal investigator
Rennes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrostimulation program (Rehab 400) in people with Chronic Renal Failure (CRF), run by Rennes University Hospital at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.