Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206634181851 Date of Approval: 21/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Beneficial Effect of Intradialytic Electrical Muscle Stimulation in Hemodialysis Patients
Official scientific title Neuromusclar fatigue and hemodynamics responses to physical exercise in patients undergoing dialysis therapy: Effects of Intradialytic Electrical Muscle Stimulation training
Brief summary describing the background and objectives of the trial hemodialysis (HD) patients cannot perform self-administered exercise training for their muscle wasting, weakness, and sarcopenia. Electrical muscle stimulation (EMS) has the advantages of easy application, and minimal risks for these patients. This study aimed to evaluate the effects of intradialytic EMS on. neuromusclar fatigue and hemodynamics responses to physical exercise.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ElectroDial
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/07/2022
Actual trial start date
Anticipated date of last follow up 30/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Electrical Muscle Stimulation Traning 12 weeks Twenty-four patients undergoing dialysis therapy (HD) will be randomly assigned to either the (EMS) group or the control (no training) group, . The EMS group will receive intradialytic EMS over an 12-week period. Measurement of isometric knee extensor strength , evaluation of the quadriceps cross-sectional area, the Timed Up & Go Test for physical function assessment, and hemodynamics responses (muscular and cerebral) during incremental exercise will be performed before and after the intervention period. 12
Control Group No intervention 12 weeks No intervention 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age of 20 years or more, dialysis duration for a minimum of 2 months with adequate dialysis delivery stable medical condition severe or symptomatic cardiovascular disease, orthopedic complaints interfering with physical function test, severe dementia Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/03/2019 CPP SUD
Ethics Committee Address
Street address City Postal code Country
Avenue Majida Boulila Sfax 3038 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neuromuscular function of the quadriceps such maximal voluntary isometric contraction (MVC), peripheral fatigue (quadriceps resting twitch force, Qtw,pot) and central fatigue (voluntary activation, VA). Also, cerebral and muscular hemodynamic response, such as oxyhemoglobin (∆O2Hb), deoxyhemoglobin (∆HHb), and total hemoglobin (∆THb) in the prefrontal cortex and in the vastus lateralis muscle. Druing physical exercise task before and follwoing the intervention period
Secondary Outcome Quadriceps Muscle volume , Body Composition Before and following the intervention period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ksour Essef dialysis unit and Renal Unit of Taher Sfar Hospital at Mahdia Ksour Essef city and Hiboun city Mahdia Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Amal Machfer Soukra road Sfax 3052 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor No Sponsor Sfax Tunisia Sfax Tunisia No sponsor
COLLABORATORS
Name Street address City Postal code Country
Taher Sfar Hospital Hiboun Mahdia 5100 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amal Machfer amalmachfer@gmail.com +201654905977 Soukra road
City Postal code Country Position/Affiliation
Sfax Tunisia University of Sfax
Role Name Email Phone Street address
Public Enquiries Semah Tagougui semah.tagougui@univ-lille.fr +330648781248 Jean Jaurs
City Postal code Country Position/Affiliation
Lille France University of Lille
Role Name Email Phone Street address
Scientific Enquiries Hamdi Chtourou h_chtourou@yahoo.fr 0021699914800 Aeroport Road
City Postal code Country Position/Affiliation
Sfax Tunisia University of Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participant data that underlie the results reported in this project, after deidentification (text, tables, figures, and appendices) will be shared Statistical Analysis Plan,Study Protocol 1 year Access to review this project is controlled. None of data are available for public before the publication of the projet's results Only scientfifc researcher or clinician are allowed to request the access to the study data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information