Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201704002116256 Date of Approval: 21/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF THERAPEUTIC EXERCISE IN THE REDUCTION OF POSTPARTUM DIASTASIS RECTI
Official scientific title EFFECT OF THERAPEUTIC EXERCISE IN THE REDUCTION OF POSTPARTUM DIASTASIS RECTI: A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Diastasis recti (DR) is a common musculoskeletal condition found during and after pregnancy (Chiarello, Falzone, McCaslin, Patel & Ulery, 2005; Spitznagle, Leong & van Dillen, 2007; Millar, 2008). Pregnancy can distend the abdomen and cause an actual separation of the two rectus abdominis muscles (Rice, 2006), which is clinically seen as a gapping of the linea alba (Sitler, 1995). Noble (1988), set the standard in the reduction of DR with the development of a specific muscle reeducation exercise alone and in combination with other physiotherapy intervention and has been promoted in a number of studies pertaining to mostly pre-natal/ante-natal exercises (Dale & Roeber, 1982; Bursch, 1987; Boissonnault & Blaschak, 1988; Polden & Mantle, 1992; Bennette & Brown, 1993; Noble, 1995). Therapeutic exercises in the reduction of DR among women postpartum have been promoted in some studies (Ketter & Shelton, 1983; Bursch, 1987; Noble, 1988; O¿Connor & Gouley, 1990; Polden & Mantle, 1992; Bennett & Brown, 1993; Hanif, 2011), some of which have some scientific limitations. It is uncertain if therapeutic exercise reduces postpartum DR. An earlier report (Lason, 1941) and more recent literature (Thorton & Thorton, 1993) advocated the use of abdominal binders for midline separations. Combined effect of Noble¿s exercise and abdominal binders has received little attention (Kotarinos, 1990) with limitations in research design (non-randomized trial, case study, no blinding) and small sample size (3-10 subjects), making it difficult to generalize to the population. The present study adopted the Noble¿s exercise protocol with an abdominal binder which is less cumbersome (Hanif, 2011). Thus, the purpose of this research was to determine the effect of therapeutic exercise on postpartum DR
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diastasis recti,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 20/11/2013
Actual trial start date 06/01/2014
Anticipated date of last follow up 17/02/2014
Actual Last follow-up date 03/03/2014
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 47
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Ethical Approval: NHREC/21/ 08/2008/ AKTH/ EC/902 Aminu Kano Teaching Hospital, Kano, Nigeria
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Noble's corrective exercise/abdominal binder The exercise regime was performed 3 times weekly, on alternate days (so as not to lose the benefit of the exercise) under the supervision of the researcher 6 week period Corrective exercise along with the use of modified less cumbersome abdominal binder 23
Control Group Conventional Treatment Daily 6 weeks Back hygienne, certain Do's and Dont's 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Diastasis recti secondary to pregnancy (postpartum DR). 2. Women 8 weeks postpartum and above participated in the study. 3. Women who had both normal vaginal delivery and Cesarean Section. 1. Pregnant women 2. Diastasis recti secondary to any other cause apart from only pregnancy 3. Presence or history of abdominal hernia 4. Presence or history of any connective tissue disease. 5. If the subjects respond ¿Yes¿ to any one of the questions in the Pre & Post Natal Physical Activity Readiness Questionnaire (PARQ), they were excluded from the study. 6. Any woman involved in abdominal conditioning prior to the study; this was determined using the criteria by Dale and Roeber (1982), the reliability and validity of which have been reported to be high. 7. If the subject has been using an abdominal binder. 19 Year(s) 49 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 18/05/2012 Aminu Kano Teaching Hospital Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Ungwa Uku Kano 700233 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Inter recti Distance Before and after intervention (6 weeks)
Secondary Outcome BMI Before intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital Ungwa Uku Kano 700233 Nigeria
Aminu Kano Teaching Hospital Physiotherapy Department, Aminu Kano Teaching Hospital Kano 700233 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Department of Physiotherapy, Bayero University Kano Kano PMB 3011 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bayero University Kano New site, Kabuga Kano PMB 3011 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Radiography Department Radiology department, AMinu Kano Teaching Hospital, Kano Kano 700233 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shmaila Hanif shelllshelll@yahoo.com +234-8038871817 Department of Physiotherapy
City Postal code Country Position/Affiliation
Kano PMB 3011 Nigeria Assistant Professor/Bayero University Kano
Role Name Email Phone Street address
Public Enquiries Bara'atu Kabir akthkano@yahoo.com +234-8057203511 Zaria road
City Postal code Country Position/Affiliation
Kano 700233 Nigeria Chairman at aminu kano teaching hospital
Role Name Email Phone Street address
Scientific Enquiries Sa'ad Musa musaadmm@yahoo.com +234-8036164090 Physical and Health Education
City Postal code Country Position/Affiliation
Kano 671101 Nigeria Senior Lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information