Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000446864p
Ethics application status
Submitted, not yet approved
Date submitted
12/03/2021
Date registered
19/04/2021
Date last updated
19/04/2021
Date data sharing statement initially provided
19/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
After childbirth, is rectus abdominis training more effective than transversus abdominis training in reducing the gap between abdominal muscles in people with diastasis of the rectus abdominis muscles (DRAM)?
Scientific title
During the early postpartum period, is rectus abdominis training more effective than transversus abdominis training in reducing the inter-recti distance in people with diastasis of the rectus abdominis muscles? A randomised controlled trial
Secondary ID [1] 303572 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diastasis of the rectus abdominis muscles 320945 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318749 318749 0 0
Physiotherapy
Musculoskeletal 319283 319283 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised into one of two treatment groups within 72 hours of giving birth.
The experimental treatment/Rectus abdomins (RA) group will be asked to complete between 1-10 x 1 second crunch (head lift) with dosage prescribed depending on patient’s technique. Exercise will be completed and assessed in crook lie and exercise prescription based on number able to complete with good technique and prior to the onset of doming of linea alba as assessed by a senior physiotherapist.

Dosage for both groups will be 1-2 x a day, at least 5 days of the week with a tick-box exercise diary provided for data on compliance. Verbal and written education will be provided at the time of exercise prescription about some exercise being better than none, and to continue even if not meeting prescribed dosages. Participants will also be taught about being able to make the exercises “Mother-baby friendly” to better fit them into their routine by encouraging baby to be completing tummy time on her chest during completion. The participants will be provided with a written home exercise program designed specifically for this study with the same information.
They will then be asked to come in for re-assessment and progression (if appropriate) at 6 and 12 weeks postpartum. Progression will include re-assessment of exercise technique and prescription of a new dosage between 1-20 repetitions of the prescribed exercise as appropriate at the week 6 review. Re-assessment will involve the standardised assessment position from baseline measures (flat supine lie with extended legs) using ultrasound to measure 2cm above/below and at the level of the umbilicus. This is the measurement technique which will also be used at baseline on the ward. Progression will not occur at the 12 week appointment as this will be the conclusion of the participant's program. Follow up appointments will have the option of being held at the hospital or as a home-based appointment and will be expected to be approximately 15 minutes in duration.

All participants will receive a modified version of the hospital's standard physiotherapy postpartum education material which will be edited to remove the current advice regarding DRAM to avoid confusion. A seperate education sheet including details of the prescribed exercise will be provided. All education and prescription will be completed face to face by a senior physiotherapist. Participants will be encouraged to return their exercise diary at each follow up appointment to monitor compliance.
Intervention code [1] 319860 0
Treatment: Other
Comparator / control treatment
The comparator treatment is the standard treatment/Transversus Abdomins (TrA) group who will be asked to complete between 1-10 x 5 second repetitions of TrA activation depending on patient’s ability and technique to complete. A senior physiotherapist will cue and observe the exercise at the time of prescription and prescribe between 1-10 repetitions as appropriate based on participant technique.

As per the experimental group, dosage will be 1-2 x a day, at least 5 days of the week with a tick-box exercise diary provided for data on compliance. Verbal and written education will be provided at the time of exercise prescription about some exercise being better than none, and to continue even if not meeting prescribed dosages. Participants will also be taught about being able to make the exercises “Mother-baby friendly” to better fit them into their routine by encouraging baby to be completing tummy time on her chest during completion. The participants will be provided with a written home exercise program designed specifically for this study with the same information.

They will then be asked to come in for re-assessment and progression (if appropriate) at 6 and 12 weeks postpartum. Progression will include re-assessment of exercise technique and prescription of a new dosage between 1-20 repetitions of the prescribed exercise as appropriate at the week 6 review. Re-assessment will involve the standardised assessment position from baseline measures (flat supine lie with extended legs) using ultrasound to measure 2cm above/below and at the level of the umbilicus. This is the measurement technique which will also be used at baseline on the ward. Progression will not occur at the 12 week appointment as this will be the conclusion of the participant's program. Follow up appointments will have the option of being held at the hospital or as a home-based appointment and will be expected to be approximately 15 minutes in duration.

All participants will receive a modified version of the hospital's standard physiotherapy postpartum education material which will be edited to remove the current advice regarding DRAM to avoid confusion. A seperate education sheet including details of the prescribed exercise will be provided. All education and prescription will be completed face to face by a senior physiotherapist. Participants will be encouraged to return their exercise diary at each follow up appointment to monitor compliance.
Control group
Active

Outcomes
Primary outcome [1] 326694 0
% change in inter-recti distance 2cm above the level of the umbilicus via ultrsound
Timepoint [1] 326694 0
Baseline, 6 weeks postpartum and 12 weeks postpartum (primary timepoint)
Primary outcome [2] 326695 0
% change in inter-recti distance at the level of the umbilicus measured via ultrasound
Timepoint [2] 326695 0
Baseline, 6 weeks postpartum and 12 weeks postpartum (primary timepoint)
Primary outcome [3] 326696 0
% change in inter-recti distance 2cm below the level of the umbilicus measured via ultrasound
Timepoint [3] 326696 0
Baseline, 6 weeks postpartum and 12 weeks postpartum (primary timepoint)
Secondary outcome [1] 392384 0
Changes in patient reported pelvic floor function measured via the validated Australian Pelvic Floor Questionnaire (APFQ)
Timepoint [1] 392384 0
Baseline, 6 weeks postpartum and 12 weeks postpartum
Secondary outcome [2] 392704 0
Changes in patient reported pelvic floor function measured via the validated Multidimensional Body Self-Relations Questionnaire - Appearance Subscale (MBSRQ)
Timepoint [2] 392704 0
Baseline, 6 weeks, 12 weeks

Eligibility
Key inclusion criteria
DRAM of >30mm at one or more of the measurement points of 2cm above/below/at the level of the umbilicus.
Delivered vaginally after 37 weeks gestation
Delivered within past 72 hours
Age 18 years and over
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Caesarean section delivery,
Delivered >72 hours prior to assessment,
< 18 years of age,
Presence of serious disease/pathology or impaired cognition contraindicating involvement in an exercise program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes containing allocation labelled with only participant I.D. number assigned once enrolled in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Completed by third party using computer generated block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2021
Actual
Date of last participant enrolment
Anticipated
25/02/2022
Actual
Date of last data collection
Anticipated
3/06/2022
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 33387 0
3280 - Warrnambool

Funding & Sponsors
Funding source category [1] 307994 0
Other Collaborative groups
Name [1] 307994 0
Western Alliance
Country [1] 307994 0
Australia
Primary sponsor type
Individual
Name
Eloise Simpson
Address
Physiotherapy Depertment
South West Healthcare
25 Ryot st
Warrnambool
VIC 3280
Country
Australia
Secondary sponsor category [1] 308714 0
Hospital
Name [1] 308714 0
South West Healthcare
Address [1] 308714 0
Physiotherapy Depertment South West Healthcare 25 Ryot st Warrnambool VIC 3280
Country [1] 308714 0
Australia
Other collaborator category [1] 281685 0
Individual
Name [1] 281685 0
Chloe Burger
Address [1] 281685 0
Physiotherapy Depertment South West Healthcare 25 Ryot st Warrnambool VIC 3280
Country [1] 281685 0
Australia
Other collaborator category [2] 281686 0
Individual
Name [2] 281686 0
Bridie Ontronen
Address [2] 281686 0
Physiotherapy Depertment South West Healthcare 25 Ryot st Warrnambool VIC 3280
Country [2] 281686 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307987 0
South West Healthcare - South West human research ethics committee
Ethics committee address [1] 307987 0
Ethics committee country [1] 307987 0
Australia
Date submitted for ethics approval [1] 307987 0
22/03/2021
Approval date [1] 307987 0
Ethics approval number [1] 307987 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109142 0
Ms Eloise Simpson
Address 109142 0
Physiotherapy Depertment South West Healthcare 25 Ryot st Warrnambool VIC 3280
Country 109142 0
Australia
Phone 109142 0
+61459325310
Fax 109142 0
Email 109142 0
[email protected]
Contact person for public queries
Name 109143 0
Eloise Simpson
Address 109143 0
Physiotherapy Depertment South West Healthcare 25 Ryot st Warrnambool VIC 3280
Country 109143 0
Australia
Phone 109143 0
+61459325310
Fax 109143 0
Email 109143 0
[email protected]
Contact person for scientific queries
Name 109144 0
Eloise Simpson
Address 109144 0
Physiotherapy Depertment South West Healthcare 25 Ryot st Warrnambool VIC 3280
Country 109144 0
Australia
Phone 109144 0
+61459325310
Fax 109144 0
Email 109144 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept SWH's conditions for access

Conditions for requesting access:
• -

What individual participant data might be shared?
• Beginning 5 years following analysis and article publication, individual participant data that underlie the result reported in this article after de-identification (text, tables, figures and appendices) will be made available long-term for use.

What types of analyses could be done with individual participant data?
• meta-analysis

When can requests for individual participant data be made (start and end dates)?
From:
The data will become available 5 years from publication indefinitely

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Contacting the PI via email ([email protected]) who will liase with the SWH HIS department

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.