Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000613808
Ethics application status
Approved
Date submitted
18/03/2021
Date registered
21/05/2021
Date last updated
22/06/2022
Date data sharing statement initially provided
21/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of three contrasting interventions on recovery of abdominal muscle separation after childbirth
Scientific title
A feasibility randomised controlled trial of three contrasting interventions for recovery of persistant post-natal diastasis of the rectus abdominis muscle
Secondary ID [1] 303732 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diastasis of the Rectus Abdominis Muscle 321187 0
Condition category
Condition code
Musculoskeletal 318980 318980 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be enrolled in the study prior to two weeks post-natal. The first baseline data (outcome measure) collection timepoint will take place at two weeks postnatal. Participants will be re-assessed at eight weeks post-natal and those that have persistent diastasis of the rectus abdominis muscle allocated to one of three groups for intervention (of 12 weeks duration):
1. Advice only
2. Abdominal support - these participants will be required to wear an abdominal support for 10-12 hours/day for 12 weeks. The abdominal support is an easily removable elasticised garment worn in a double layer extending from the pubic symphysis to the xiphoid process of the sternum. Instructions for wear and fitting will be provided by an experienced Women's Health Physiotherapist. Participants will be asked to complete a diary to monitor adherence to the intervention.
3. Abdominal exercise- these participants will be required to see a Physiotherapist for 7 sessions over 12 weeks for exercise prescription and progression and be asked to perform these exercises at home 5 times per week for 20 minutes. Exercises will commence with static activation of the transverses abdominis muscle in crook-lying, side-lying and 4-point-kneel position. These will be progressed to including arm and/or leg movements and further progressed to involve movement of the Thorax on the lumbar spine i.e. curl-up, Russian twist. Exercises are of a low-moderate intensity and will be performed until fatigue. This will be assessed via monitoring of posture, breathing and correct muscle activation patterns. Participants will be asked to complete an exercise diary to monitor adherence to the intervention.
Outcome measures will be reassessed at the end of the intervention i.e. at 20 weeks post-natal, with the final outcome measure data collection to take place 3 months following the end of the intervention i.e. when participants are 32 weeks post-natal.
Intervention code [1] 320050 0
Treatment: Other
Comparator / control treatment
The control group is the "Advice only" group. This group will receive one 30 minute advice session regarding movement optimisation and posture by an experience Women's Health Physiotherapist at 8-weeks post-natal.

Outcome measure data collection will take place at two weeks post-natal, eight weeks post-natal (at which point women with persistent DRAM will be allocated to an intervention group) and at the end of the 12 -week intervention i.e. at 20 weeks post-natal. The final outcome measure data collection to take place 3 months following the end of the intervention i.e. when participants are 32 weeks post-natal.
Control group
Active

Outcomes
Primary outcome [1] 326897 0
The primary outcome measure is the Linea alba distortion index.
Real-time Ultrasound Imaging will be used to image the abdominal muscle inter-rectii distance and the linea alba distortion index subsequently measured from this image.
Timepoint [1] 326897 0
12 weeks following commencement of intervention i.e. 20 weeks following baseline data measurement
Secondary outcome [1] 393040 0
Inter-rectii distance. This will be measured using real-time Ultrasound imaging.
Timepoint [1] 393040 0
At 3 months post completion fo the intervention i.e. 20 weeks following baseline data measurement
Secondary outcome [2] 395819 0
Roland Morris Questionnaire for low back pain
Timepoint [2] 395819 0
At 3 months post completion of the intervention i.e. 20 weeks following baseline data measurement
Secondary outcome [3] 395820 0
Pelvic Girdle Pain Questionnaire
Timepoint [3] 395820 0
At 3 months post completion of the intervention i.e. 20 weeks following baseline data measurement.
Secondary outcome [4] 395821 0
Pelvic Floor Distress Inventory
Timepoint [4] 395821 0
At 3 months post completion of the intervention i.e. 20 weeks following baseline data measurement
Secondary outcome [5] 395822 0
Body Quality of Life Questionnaire for Body Image
Timepoint [5] 395822 0
At 3 months post completion of the intervention i.e. 20 weeks following baseline data measurement
Secondary outcome [6] 395823 0
Exercise Diary
Timepoint [6] 395823 0
At 3 months post completion of the intervention i.e. 20 weeks following baseline data measurement
Secondary outcome [7] 395824 0
International Physical Activity Questionnaire
Timepoint [7] 395824 0
At 3 months post completion of the intervention i.e. 20 weeks following baseline data measurement

Eligibility
Key inclusion criteria
• aged > 18 years;
• <2 weeks postnatal at time of enrolment into study;
• Primiparous (first pregnancy or first pregnancy beyond 20 weeks’ gestation);
• Willing/able to travel to follow up appointments at site of data collection
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Obstetric anal sphincter injury;
• Caesarean section;
• BMI > 30;
• Any major medical condition that precludes performance of an exercise program;
• History of musculoskeletal pain sufficient to limit function in the 3 years prior to
conception;
• Provision of Physiotherapy management for pregnancy related musculoskeletal or pelvic
floor function in the past 6 months;
• Urinary incontinence prior to conception;
• Pre-existing pelvic organ prolapse (if known);
• History of spinal/pelvic fractures or lumbar spine surgery;
• Neurological or neuromuscular conditions;
• Chronic Respiratory conditions;
• Inability to read/understand English.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/06/2021
Actual
11/06/2021
Date of last participant enrolment
Anticipated
30/01/2023
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
100
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 308139 0
Hospital
Name [1] 308139 0
Metro South Health Hospital Service
Country [1] 308139 0
Australia
Primary sponsor type
Individual
Name
Dr Tanja Miokovic
Address
Physiotherapy Department- Redland Hospital
Weippin Street,
Cleveland,
QLD, 4163
Country
Australia
Secondary sponsor category [1] 308902 0
None
Name [1] 308902 0
Address [1] 308902 0
Country [1] 308902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308125 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 308125 0
Royal Brisbane and Women's Hospital
Butterfield St, Herston,
QLD, 4029
Ethics committee country [1] 308125 0
Australia
Date submitted for ethics approval [1] 308125 0
22/02/2021
Approval date [1] 308125 0
16/03/2021
Ethics approval number [1] 308125 0

Summary
Brief summary
This aim of this pilot trial is to assess the best management approach to rehabilitation of postnatal Diastasis of the Rectus Abdominis Muscle (DRAM), commonly referred to as abdominal muscle separation, 100 first-time mothers will be recruited for this study. Participants with DRAM at 6-8 weeks postnatal will be allocated to one of three intervention groups: advice only; abdominal binder; back and abdominal muscle exercise.

Ultrasound imaging will be used to collect images of the abdominal muscles for the linea alba distortion index (primary outcome measure) and inter-rectii distance. Additional outcome measures include- low back pain, pelvic girdle pain, stress urinary incontinence and body image.

It is hypothesised that: 1) the linea alba tension rather than the inter-rectii distance will have more of an impact on functional outcomes of low back and pelvic girdle pain, body image and pelvic floor function; and 2) the exercise group will demonstrate significantly less linea alba distortion than the control or abdominal binder groups.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109626 0
Dr Tanja Miokovic
Address 109626 0
Physiotherapy Department,
Redland Hospital,
Weippin Street,
Cleveland, QLD,
4163
Country 109626 0
Australia
Phone 109626 0
+61 7 3488 3222
Fax 109626 0
Email 109626 0
[email protected]
Contact person for public queries
Name 109627 0
Dr Tanja Miokovic
Address 109627 0
Physiotherapy Department,
Redland Hospital,
Weippin Street,
Cleveland, QLD,
4163
Country 109627 0
Australia
Phone 109627 0
+61 7 3488 3222
Fax 109627 0
Email 109627 0
[email protected]
Contact person for scientific queries
Name 109628 0
Dr Tanja Miokovic
Address 109628 0
Physiotherapy Department,
Redland Hospital,
Weippin Street,
Cleveland, QLD,
4163
Country 109628 0
Australia
Phone 109628 0
+61 7 3488 3222
Fax 109628 0
Email 109628 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


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.