Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001295538
Ethics application status
Approved
Date submitted
19/08/2024
Date registered
25/10/2024
Date last updated
25/10/2024
Date data sharing statement initially provided
25/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Physiotherapy management options for women who experience separation of their abdominal muscles in the first 6 months after giving birth
Scientific title
Is rectus abdominis training, or transversus abdominis training, or natural recovery, more effective for reducing the inter-recti distance in women with Diastasis of the Rectus Abdominis Muscles during the early postpartum period? A randomized controlled trial.
Secondary ID [1] 311060 0
None
Universal Trial Number (UTN)
Trial acronym
DRAM Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diastasis of the Rectus Abdominis Muscles 332183 0
Condition category
Condition code
Musculoskeletal 328899 328899 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 331595 331595 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two exercise intervention arms will be delivered via a consultation with a physiotherapist prior to discharge from hospital, with review sessions scheduled for 6 weeks, 12 weeks and 26 weeks post randomisation (all with a physiotherapist),

The two exercise intervention arms in the trial are:

1) Transversus Abdominus (TrA) training - between 1-10 repetitions held for 3-5 seconds of TrA activation in either a crook lying, side lying or 4-point kneeling position depending on patient-specific ability and technique to complete as measured by lateral slide and change in thickness of the TrA using ultrasound machine. The treating physiotherapist will cue and observe the exercise at the time of prescription to determine the optimal starting dosage, position and map out appropriate progressions for the first six weeks postpartum, given abdominal muscle function is likely to change significantly across this time.

2) Rectus Abdominus (RA) training - between 1-10 repetitions of a crunch movement held for 3-5 seconds each repetition. The patient will be cued to lift their head to a level they are able to control and tolerate well. This may be a head lift or up to a crunch movement where the shoulder blades leave the bed, dependent on patient ability. This is to best match what would typically be prescribed clinically and accounts well for both differences in abdominal muscle function across both vaginal and Caesarean Section deliveries. The dosage will once again be prescribed depending on each patient’s technique. The exercise will be completed and assessed in a crook lie position and exercise prescription based on the number of repetitions able to be completed with good technique and prior to the onset of doming or caving of the linea alba.

Dosage for both groups will be 1-2 sets per day, >5 days of the week with compliance measured electronically via Simple Set (exercise prescription software). Participants will then be asked to come in for re-assessment and progression of dosage and/or position (if appropriate) at 6 and 12 weeks postpartum. Initial contact with the physiotherapists is expected to last 30-45 minutes, with up to 30 minute review appointments, all being held as one on one , face-to-face appointments.

6-week progression of programs:
TrA
The dosage will remain between 1-10 repetitions prescribed, but progression will be determined by either increasing the length of the contraction, increasing the number of the repetitions (if originally prescribed less than 10) and/or progression from early training positions (crook lie, side lie and/or 4-point kneeling) to sitting, standing and/or walking (as would be used functionally throughout the day). This will once again be determined based on observed lateral displacement of the TrA muscle during contraction as measured on ultrasound and matches what a typical progression would clinically be.

RA
The dosage will also remain between 1-10 repetitions of the exercise. However, as RA is not typically used during functional tasks in the same way the TrA is, the position will not be altered. However, if a participant can achieve 10 repetitions of a 2 second crunch without doming or caving of the linea alba, they will be instructed to increase the range of the movement as a progression up to and including lifting the scapula off the bed depending on participant technique. Dosage will once again be based on the number of repetitions able to be achieved with good technique and no doming or caving of the linea alba.

In both active intervention groups, exercises will be taught in a mother-baby friendly way by incorporating either infant tummy time or encouraging 4-point kneeling over the supine infant to aid in adherence.

At 12 weeks participants will be advised they do not need to continue to adhere to their specific exercise program. A final re-assessment will then be completed 6 months postpartum.
Intervention code [1] 327506 0
Treatment: Other
Comparator / control treatment
No exercise group: a standard care post-childbirth consultation with a physiotherapist will be completed prior to discharge from the hospital. Review sessions will occur at 6 weeks, 12 weeks and 6 months postpartum (all with a physiotherapist).

All three groups will receive the standardised education delivered by a physiotherapist regarding pelvic floor muscle exercises, toileting following birth, return to movement and exercise and when to seek out physiotherapy input for concerns regarding pelvic floor or musculoskeletal health. All participants will be provided with South-West Healthcare’s post-childbirth information booklet which includes general information about DRAM without reference to any exercises.

Initial contact with the physiotherapists is expected to last 30-45 minutes, with up to 30 minute review appointments, all being held as one on one , face-to-face appointments.
Control group
Active

Outcomes
Primary outcome [1] 336711 0
Inter-recti distance at the level of the superior border of the umbilicus
Timepoint [1] 336711 0
12-weeks postpartum
Secondary outcome [1] 429390 0
Inter-recti distance at the level of the superior border of the umbilicus
Timepoint [1] 429390 0
Baseline, 6-weeks postpartum, 6-months postpartum
Secondary outcome [2] 429392 0
Inter-recti distance 2cm above the umbilicus
Timepoint [2] 429392 0
Baseline, 6-weeks post partum, 12-weeks postpartum, 6-months postpartum
Secondary outcome [3] 429398 0
Pelvic floor dysfunction
Timepoint [3] 429398 0
Baseline, 6-weeks postpartum, 12-weeks postpartum and 6-months postpartum
Secondary outcome [4] 429399 0
Body satisfaction
Timepoint [4] 429399 0
Baseline, 6-weeks postpartum, 12-weeks postpartum and 6-months postpartum
Secondary outcome [5] 429400 0
Anterior abdominal wall force transfer
Timepoint [5] 429400 0
Baseline, 6-weeks postpartum, 12-weeks postpartum and 6-months postpartum
Secondary outcome [6] 429401 0
Pelvic Girdle Pain
Timepoint [6] 429401 0
Baseline, 6-weeks postpartum, 12-weeks postpartum and 6-months postpartum
Secondary outcome [7] 429402 0
Low back pain
Timepoint [7] 429402 0
Baseline, 6-weeks postpartum, 12-weeks postpartum and 6-months postpartum
Secondary outcome [8] 429403 0
Abdominal pain and/or discomfort. This will be assessed as a composite outcome.
Timepoint [8] 429403 0
Baseline, 6-weeks postpartum, 12-weeks postpartum and 6-months postpartum
Secondary outcome [9] 429404 0
Quality of life
Timepoint [9] 429404 0
Baseline, 6-weeks postpartum, 12-weeks postpartum and 6-months postpartum
Secondary outcome [10] 429405 0
Automatic contraction of the transversus abdominis muscle
Timepoint [10] 429405 0
Baseline, 6-weeks postpartum, 12-weeks postpartum and 6-months postpartum
Secondary outcome [11] 429406 0
Patient-reported satisfaction with outcome
Timepoint [11] 429406 0
Baseline, 6-weeks postpartum, 12-weeks postpartum and 6-months postpartum
Secondary outcome [12] 432256 0
Automatic contraction percentage of the transversus abdominis muscle from rest to activation
Timepoint [12] 432256 0
Baseline, 6 weeks postpartum, 12 weeks postpartum and 6 months postpartum

Eligibility
Key inclusion criteria
-Women who have delivered a baby at or after 37 weeks gestation within past 72 hours
-Age greater than or equal to 18 years
-Presence of diastasis of the rectus abdominis muscle (DRAM) of greater than or equal to 28mm at the level of the superior border of the umbilicus when measured with ultrasound at rest in supine position.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- delivered >72 hours prior to assessment,
- < 18 years of age have been excluded due to high vulnerability,
- presence of serious disease/pathology or impaired cognition contraindicating involvement in an exercise program.
- Resides greater than 20km from South West Healthcare’s Warrnambool campus, to maximise feasibility of return visits and due to the inability to offer home-based re-assessment with a senior physiotherapist outside of this radius because of the excessive travel time required.

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)
Prior to the recruitment of the first participant, an offsite researcher will use a computer-generated randomisation schedule to generate individual sealed opaque envelopes which will be labelled only with the stratification category and a sequential participant number. The envelopes will be opened on-site only after enrolment of a participant by the treating physiotherapist to reveal that participant’s group allocation, and only the treating physiotherapist will see the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher at La Trobe University who will have no contact with any potential or actual participants will prepare the randomisation schedule and sealed opaque labelled envelopes offsite. Randomisation will be stratified based on two factors to include even distribution of participants between the three groups with relation to vaginal vs caesarean delivery method, and mild/moderate vs severe DRAM (>50mm) at the level of the umbilicus. Block randomisation with random block sizes will be used to facilitate balanced group sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Data will be analyzed using SPSS. Linear mixed models will be used to evaluate between-group effects on primary and secondary outcomes, accounting for the repeated measures design and adjusting for baseline scores. Missing data will be managed via maximum likelihood estimation within the linear mixed models, allowing data from all participants to contribute to outcome modelling in their randomized groups even when lost to follow-up, thus satisfying intention to treat analysis principles.

Moderating and mediating factors will also be explored as outlined below:
Determine whether any of the following variables moderate the between-group treatment effect at 6 weeks, 12 weeks or 6 months):
- Breastfeeding
- Delivery method (cesarean or vaginal)
- DRAM severity

Determine whether any of the following variables mediate the effect of treatment on IRD, pelvic floor dysfunction and/or pain, body image, quality of life, low back pain, or satisfaction with outcome, at 6 weeks, 12 weeks or 6 months:
1. Change in TrA activation as measured on ultrasound as millimetres of lateral displacement during single full leg lift in a supine position
2. Change in TrA activation as measured on ultrasound as contraction thickness percentage during single full leg lift in a supine position
3. Adherence to treatment (for active intervention groups)
4. Linea alba distortion


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2024
Actual
Date of last participant enrolment
Anticipated
24/11/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25896 0
South West Healthcare - Warrnambool - Warrnambool
Recruitment postcode(s) [1] 41731 0
3280 - Warrnambool

Funding & Sponsors
Funding source category [1] 315318 0
Other Collaborative groups
Name [1] 315318 0
Western Alliance
Country [1] 315318 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
25 Ryot st, Warrnambool, Victoria
Country
Australia
Secondary sponsor category [1] 317371 0
None
Name [1] 317371 0
Address [1] 317371 0
Country [1] 317371 0
Other collaborator category [1] 282886 0
Hospital
Name [1] 282886 0
South West Healthcare
Address [1] 282886 0
Plenty rd, Bundoora, Victoria
Country [1] 282886 0
Australia
Other collaborator category [2] 282999 0
University
Name [2] 282999 0
Norwegian School of Sports Sciences
Address [2] 282999 0
Country [2] 282999 0
Norway

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314239 0
South West Healthcare - South West Human Research Ethics Committee
Ethics committee address [1] 314239 0
Ethics committee country [1] 314239 0
Australia
Date submitted for ethics approval [1] 314239 0
14/09/2023
Approval date [1] 314239 0
20/12/2023
Ethics approval number [1] 314239 0
HREC/102454/SWH-2023-406892(v5)
Ethics committee name [2] 314240 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 314240 0
Ethics committee country [2] 314240 0
Australia
Date submitted for ethics approval [2] 314240 0
06/12/2023
Approval date [2] 314240 0
03/01/2024
Ethics approval number [2] 314240 0
HREC/102454/SWH-2023-406892(v5)

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

Contacts
Principal investigator
Name 130906 0
Ms Eloise Simpson
Address 130906 0
Physiotherapy Department, South West Healthcare, 25 Ryot st, Warrnambool, Victoria 3280
Country 130906 0
Australia
Phone 130906 0
+61 3 5563 1528
Fax 130906 0
Email 130906 0
esimpson@swh.net.au
Contact person for public queries
Name 130907 0
Eloise Simpson
Address 130907 0
Physiotherapy Department, South West Healthcare, 25 Ryot st, Warrnambool, Victoria 3280
Country 130907 0
Australia
Phone 130907 0
+61 3 5563 1528
Fax 130907 0
Email 130907 0
esimpson@swh.net.au
Contact person for scientific queries
Name 130908 0
Eloise Simpson
Address 130908 0
Physiotherapy Department, South West Healthcare, 25 Ryot st, Warrnambool, Victoria 3280
Country 130908 0
Australia
Phone 130908 0
+61 3 5563 1528
Fax 130908 0
Email 130908 0
esimpson@swh.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data after de-identification (text, tables, figures and appendices)
When will data be available (start and end dates)?
Following analysis and article publication. No end date for availability
Available to whom?
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 which includes permission of the chief investigator.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Request for access can be directed to the Research Department at South West Healthcare SWHResearch@swh.net.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22155Study protocol    Manuscript in preparation
22156Statistical analysis plan    Will be published with the trial protocol
22157Informed consent form  SWHResearch@swh.net.au Available from the South West Healthcare Research ... [More Details]
22158Ethical approval  SWHResearch@wh.net.au HREC/102454/SWH-2023-406892



Results publications and other study-related documents

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