ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

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]

Inter-recti distance at the level of the superior border of the umbilicus

Timepoint [1]

12-weeks postpartum

Secondary outcome [1]

Inter-recti distance at the level of the superior border of the umbilicus

Timepoint [1]

Baseline, 6-weeks postpartum, 6-months postpartum

Secondary outcome [2]

Inter-recti distance 2cm above the umbilicus

Timepoint [2]

Baseline, 6-weeks post partum, 12-weeks postpartum, 6-months postpartum

Secondary outcome [3]

Pelvic floor dysfunction

Timepoint [3]