Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000539831
Ethics application status
Approved
Date submitted
10/03/2021
Date registered
7/05/2021
Date last updated
7/05/2021
Date data sharing statement initially provided
7/05/2021
Date results provided
7/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of core muscle training vs. outer abdominal muscle training during the first three months postpartum on the size of the gap in abdominal muscles after birth in patients with diastasis of the rectus abdominis muscles
Scientific title
The effect of early post-partum rectus abdominis training vs. transversus abdominis training on the inter-recti distance in patients with diastasis of the rectus abdominis muscles: a pilot study
Secondary ID [1] 303657 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 (DRAM) 321050 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318852 318852 0 0
Physiotherapy
Musculoskeletal 319228 319228 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.
Those in the experimental intervention group will be asked to complete the following protocol:
Between 1-10 x 1 second crunch (head lift) with dosage prescribed once again 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 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 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 are expected to run for 15 minutes each.

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 created for the study 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] 319959 0
Treatment: Other
Comparator / control treatment
Standard treatment/Transversus Abdomins (TrA) group will be asked to complete the following protocol:
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 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 are expected to run for 15 minutes each.

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 created for the study 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] 326797 0
% change in inter-recti distance 2cm above the level of the umbilicus measured via the mean of three measurements using digital calipers
Timepoint [1] 326797 0
Baseline, 6 weeks and 12 weeks (primary timepoint)
Primary outcome [2] 326798 0
% change in inter-recti distance at the level of the umbilicus measured via the mean of three measurements using digital calipers
Timepoint [2] 326798 0
Baseline, 6 weeks, 12 weeks (primary timepoint)
Primary outcome [3] 326799 0
% change in inter-recti distance 2cm below the level of the umbilicus measured via the mean of three measurements using digital calipers
Timepoint [3] 326799 0
Baseline, 6 weeks, 12 weeks (primary timepoint)
Secondary outcome [1] 392707 0
Changes in patient reported pelvic floor function measured via the validated Australian Pelvic Floor Questionnaire (APFQ)
Timepoint [1] 392707 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
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)
Allocation schedule completed prior to enrollment and stored in a password protected excel spreadsheet accessible only by PI. Allocation details provided only after enrollment to treating physiotherapist only (who was blinded to assessment outcomes)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Independent sample t-tests in SPSS software used to calculated between-group differences. Mann-Whitney U tests to calculate differences in APFQ scores between groups

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/11/2019
Date of last participant enrolment
Anticipated
Actual
31/01/2020
Date of last data collection
Anticipated
Actual
30/03/2020
Sample size
Target
50
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 33388 0
3280 - Warrnambool

Funding & Sponsors
Funding source category [1] 308282 0
Hospital
Name [1] 308282 0
South West Healthcare
Country [1] 308282 0
Australia
Primary sponsor type
Individual
Name
Eloise Simpson
Address
Physiotherapy department
South West Healthcare
25 Ryot st
Warrnambool
VIC 3280
Country
Australia
Secondary sponsor category [1] 308813 0
Hospital
Name [1] 308813 0
South West Healthcare
Address [1] 308813 0
25 Ryot st
Warrnambool
VIC 3280
Country [1] 308813 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308065 0
South West Healthcare
Ethics committee address [1] 308065 0
Ethics committee country [1] 308065 0
Australia
Date submitted for ethics approval [1] 308065 0
23/09/2019
Approval date [1] 308065 0
14/10/2019
Ethics approval number [1] 308065 0
LNR/57439/SWH-2019-188540(v1)

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

Contacts
Principal investigator
Name 109402 0
Ms Eloise Simpson
Address 109402 0
Physiotherapy department
South West Healthcare
25 Ryot st
Warrnambool
VIC 3280
Country 109402 0
Australia
Phone 109402 0
+61459325310
Fax 109402 0
Email 109402 0
[email protected]
Contact person for public queries
Name 109403 0
Eloise Simpson
Address 109403 0
Physiotherapy department
South West Healthcare
25 Ryot st
Warrnambool
VIC 3280
Country 109403 0
Australia
Phone 109403 0
+61459325310
Fax 109403 0
Email 109403 0
[email protected]
Contact person for scientific queries
Name 109404 0
Eloise Simpson
Address 109404 0
Physiotherapy department
South West Healthcare
25 Ryot st
Warrnambool
VIC 3280
Country 109404 0
Australia
Phone 109404 0
+61459325310
Fax 109404 0
Email 109404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Was not included in the informed consent document that participants signed


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.