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.: PACTR202110679363984 Date of Registration: 29/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title What are the effective exercises after childbirth for the belly and the pelvic floor
Official scientific title Specifics effects of the Crunch, the Drawing-in and the diaphragmatic aspiration on the abdominal wall and the pelvic floor in postpartum
Brief summary describing the background and objectives of the trial After pregnancy and delivery, the pelvic floor and the abdominal muscles are weakened and less functional. Various disorders can be observed as a consequence of these modifications, such as abdominal ptosis, diastasis recti, urinary incontinence, organ prolapse (Ragni, Lousquy, Costa, Delmas, & Haab, 2009; Sperstad, Tennfjord, Hilde, Ellstrom-Engh, & Bo, 2016). Abdominoperineal rehabilitation aims to prevent the onset of these disorders after delivery, as well as to handle them after their appearance and to avoid recurrence after treatment. The abdominal strengthening programs offered through the literature combine several exercises (El-Mekawy et al 2013)(Benjamin et al 2014; Chiarello et al 2005; Gluppe et al 2018; Khandale & Hande 2016; Mahalakshmi et al 2016; Walton et al 2016). The specific effects of the different exercises performed in these combined programs are not known. Recently, the Crunch has been shown to acutely decrease the inter rect distance (Chiarello et al 2016; Gluppe et al 2020; Lee & Hodges 2016; Mota et al 2015; Pascoal et al 2014; Sancho et al 2015) and to cause a distorsion of the linea alba (Beamish et al 2019; Lee & Hodges 2016). The Drawing-in has been shown to increase the inter recti distance (Gluppe et al 2020; Mota et al 2015; Sancho et al 2015; Theodorsen et al 2018) and to improve the tension of the linea alba (less distorsion) (Beamish et al 2019; Lee & Hodges 2016). The aim of this research is to highlight the training effects of the Crunch versus the combination of Drawing-in and diaphragmatic aspiration on the abdominal wall and the pelvic floor in postpartum women after vaginal delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diastasis recti,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 19/09/2021
Actual trial start date 03/10/2021
Anticipated date of last follow up 22/04/2022
Actual Last follow-up date 30/04/2022
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 58
Recruitment status Completed
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control 6 weeks Nothing 30 Placebo
Experimental Group Crunch 45 minutes- 18 sessions - 3 times per week 6 weeks Crunch exercises and variantes : crunch twist, reverse crunch, lateral crunch, crunch at standing All exercices are doing at the clinic and will be supervised by the physiotherapist Session with 3 to 6 participants 30
Experimental Group Drawingin and diaphragmatic aspiration 45 minutes - 18 sessions - 3 times per week 6 weeks Drawing-in and diaphragmatic aspiration exercises and variantes in supine, lateral and standing All exercises are doing at the clinic and will be supervised by the physiotherapist Sessions with 3 to 6 participants 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Being at least 18 years old and 40 years maximum. Being a parous woman who has given birth at least 6 weeks ago and less than 12 weeks ago. Having an inter recti distance over 22.5 mm measured with ultrasound Pregnant woman. Woman who has had abdominal surgery including cesarean section Multiparous woman with a parity greater than 3. Woman with an organ prolapse at the third stage Woman who had 0 or -1 for the strength of pelvic floor muscle (0 = any contraction, -1 = push rather than contract) Woman who has not completed at least 12 sessions out of the 18 planned Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 18 Year(s) 40 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 01/07/2020 Comite Ethique de la Recherche CER CUMPR CNHU
Ethics Committee Address
Street address City Postal code Country
Avenue Jean Paul II Cotonou 01 BP 386 Benin
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 01/07/2020 Comite Ethique de la Recherche CER CUMPR CNHU
Ethics Committee Address
Street address City Postal code Country
Avenue Jean Paul II Cotonou 01 BP 386 Benin
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Inter recti distance: A portable 2D ultrasound (Chison Eco) will be used to assess IRD at 2 cm and 5 cm above the umbilicus during rest and Head lift. (Benjamin et al 2020; Chiarello & McAuley 2013; Rejano-Campo & Pizzoferrato 2020) Linea tonicity with finger palpation Abdominal muscle strengthening and endurance: dynamometer, manual test (Hislop et al 2015) itto test (Fransoo et al 2009; Ito et al 1996). 6 to 12 weeks after chilbirth, after protocol
Secondary Outcome Abdominal circumference: centimeter Abdominal skinfold: ultrasound Pelvic floor muscles tone, strength, endurance and maximal voluntary contractions within 60 seconds, perineal contraction during cough effort and anticipatory pelvic floor muscles contraction during effort: biofeedback phenix USB Micro Full with vaginal probe Urinary incontinence: ICIQ-UI-SF (Hajebrahimi et al 2012), Pad test (Krhut et al 2014) Organ prolapse: POPDI-6 (De Tayrac et al 2007) 6 to 12 weeks after chilbirth, after protocol
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Clinique Universitaire de Medecine Physique et Readaptation CUMPR Avenue Jean Paul II Cotonou Benin
Centre Hospitalier Universitaire de la Mere Enfant Lagune CHU MEL Missebo Cotonou Benin
FUNDING SOURCES
Name of source Street address City Postal code Country
Yollande Djivoh Akpakpa Cotonou Benin
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CNHU Avenue Jean Paul II Cotonou 01 BP386 Benin Hospital
Secondary Sponsor CHUMEL Ganhi Missebo Cotonou Benin Hospital
COLLABORATORS
Name Street address City Postal code Country
UCL Place Pierre de Coubertin 1 Louvain La Neuve 1348 Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Dominique De Jaeger dominique.dejaeger@uclouvain.be 003210474506 Place du Coubertin 1
City Postal code Country Position/Affiliation
Louvain la neuve 1348 Belgium Promoter
Role Name Email Phone Street address
Principal Investigator Yollande Djivoh yollande.djivoh@uclouvain.be 0022961194241 Akpakpa Agbodjedo
City Postal code Country Position/Affiliation
Cotonou Benin PhD student
Role Name Email Phone Street address
Public Enquiries Toussaint Kpadonou kpadonou_toussaint@yahoo.fr 0022997588926 Cotonou
City Postal code Country Position/Affiliation
Cotonou Benin Supervisor CNHU
Role Name Email Phone Street address
Public Enquiries Patrice Dangbeme ddpatous78@yahoo.fr 0022965475858 Cotonou
City Postal code Country Position/Affiliation
Cotonou Benin Supervisor CHU MEL
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of IPD included in the protocol of the trial would be available after de-identification and publication of the study Study Protocol IPD would be available after publication of the study and at any time Researchers would had access to the IPD after justifying the scientific use of it and after the contributors of the trial agree on it
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