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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901640930094 Date of Registration: 21/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Russian current stimulation on abdominal strength and endurance in postnatal diastasis recti a randomized control trial
Official scientific title Effect of Russian current stimulation on abdominal strength and endurance in postnatal diastasis recti a randomized control trial
Brief summary describing the background and objectives of the trial Diastasis of the rectus abdominis muscle is common during and after pregnancy with prevalence rates between 27% and 100% in the second and third trimesters of pregnancy and 30–68% in the postpartum period . So the aim of this trial is to investigate the effect of Russian current stimulation on abdominal strength and endurance in postnatal diastasis recti
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DR IRD RS
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 30/12/2018
Actual trial start date 15/01/2019
Anticipated date of last follow up 15/02/2019
Actual Last follow-up date 01/03/2019
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Russian current stimulation 3 session per week 30 minute per session , 3 session per week for 6 weeks plus selected exercise program 3sessions per week for six weeks All women in this group will receive Russian current stimulation using 4 surface electrodes bilaterally on rectus abdominus muscles for 30 minute per session , 3 session per week for 6 weeks plus selected exercise program 3sessions per week for six weeks, this exercise program consists of static abdominal contraction, posterior pelvic tilt, sit-up exercise, reverse sit-up exercise, trunk twist and reverse trunk twist exercise 20
Control Group selected exercise program 3sessions per week 30 minute per session , 3 session per week for 6 weeks All women in this group will receive selected exercise program only 3sessions per week for six weeks, this exercise program consists of static abdominal contraction, posterior pelvic tilt, sit-up exercise, reverse sit-up exercise, and reverse trunk twist exercise 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- The patients will be diagnosed by gynecologist as having postnatal diastases recti of 25mm or more based on ultrasongraghic assessment 2- Their ages will be ranged from 25-35 years old 3- Their body mass index (BMI) will be less than 30 kg/m² 4- All patients have delivered normally 5- All patients will have a parity of 2-4 children 1- The patients who will have any disease that interferes with exercises (asthma) 2- Any skin disease or sensitivity that interferes with the use of Russian current stimulation electrodes 3- Any chest disease or cardiac disease. Adult: 18 Year(s)-44 Year(s) 25 Year(s) 35 Year(s) Female
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 30/12/2018 PT REC
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Dokky, Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The inter recti distance (IRD) at the begining of the study and after the end of the study 6weeks
Secondary Outcome Abdominal muscles strength in terms of peak torque, maximum repetition total work, and average power at the begining of the study and after the end of study 6 weeks
Secondary Outcome Abdominal endurance at the begining of the study and after 6 weeks
Secondary Outcome Waist & hip circumference measurement at the begining of the study and after 6 weeks
Secondary Outcome Shape evaluation scale at the begining of the study and after 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
OUT CLINIC OF FACULITY OF PHYSICAL THERAPY UNIVERSITY STREET GIZA Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Afaf Mohamed Mahmoud Botla Al Qaliobia, Al Qanater Al Khayria, Sendpeace, Gamal Abd Al Naser Street. Al Qanater Al Khayria 1122 Egypt
Marwa shafiek Mustafa saleh 6 October, Bolaa El-Dakror. GIZA 3455 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FACULITY OF PHYSICAL THERAPY UNIVERSITY STREET GIZA Egypt University
COLLABORATORS
Name Street address City Postal code Country
Marwa shafiek Mustafa saleh 6 October, Bolaa El-Dakror Giza 3455 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AFAF BOTLA drafafmohamed@yahoo.com 01283126608 Sendpeace, Gamal Abd Al Naser Street.
City Postal code Country Position/Affiliation
Al Qaliobia 1122 Egypt LECTURER
Role Name Email Phone Street address
Scientific Enquiries AFAF BOTLA drafafmohamed@yahoo.com 01283126608 Gamal abd el naser street
City Postal code Country Position/Affiliation
Al Qaliobia 1122 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Marwa Saleh Marwa_shafiek2000@yahoo.com 01008342466 6 October, Bolaa El-Dakror.
City Postal code Country Position/Affiliation
Giza 3455 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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