Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001182583
Ethics application status
Approved
Date submitted
2/09/2024
Date registered
27/09/2024
Date last updated
27/09/2024
Date data sharing statement initially provided
27/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
POSTFIT: Postpartum Optimised Strength Training and Fitness - A testing battery and exercise intervention for postpartum women
Scientific title
POSTFIT: Postpartum Optimised Strength Training and Fitness - A testing battery and exercise intervention for postpartum women
Secondary ID [1] 312866 0
Nil known
Universal Trial Number (UTN)
Trial acronym
POSTFIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum 335005 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331519 331519 0 0
Other physical medicine / rehabilitation
Musculoskeletal 331520 331520 0 0
Other muscular and skeletal disorders
Reproductive Health and Childbirth 331605 331605 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Procedure
This study consists of four phases addressing separate research questions and aims. Participants will be recruited at baseline and will progress sequentially through each phase of the larger study as detailed below.

Phase 1
Pre-intervention assessments and baseline testing (completed by Groups 1 & 2)
Phase 2
Week one to 12 of a 12 week supervised exercise intervention (Group 1 only)
Phase 3
Post-intervention assessments (Groups 1 & 2)
Phase 4
One year followup consisting of several questionnaires which will be electronically sent to participants (Groups 1 & 2)

Assessment and baseline testing:
Once enrolled, the participant will complete various physical assessments and questionnaires.

The assessments will be conducted prior to the exercise intervention to screen for common postpartum musculoskeletal injuries and to assess baseline strength and function, and we envisage that they will take approximately 60 – 90 minutes per participant. The proposed outcome measures are routinely used in clinical practice by Exercise Physiologists, and they are considered safe and straightforward to conduct (by the Exercise Physiologist) and complete (by the participant). Additionally, the Exercise and Sports Science Australia (ESSA) scope of practice and professional standards outlines that Exercise physiologists can screen, assess, and measure capacity and function to inform interventions and improve health outcomes https://www.essa.org.au/Public/Public/Professional_Standards/ESSA_Scope_of_Practice_documents.aspx.

Test order
Tests will be conducted in a specified order so that participants are provided enough rest between tests and to ensure that results from the previous test do not affect subsequent tests. For example, provocation tests will be alternated with strength tests and participants fatigue and RPE will be monitored throughout.

Group one Supervised Exercise Intervention
All participants in the supervised exercise group will then complete a 12-week individualized exercise program which will be undertaken in one of the exercise clinics listed below (depending on which are the participant was recruited from) under the supervision of an Accredited Exercise Physiologist (AEP). The participants will undergo further testing mid intervention (week six), post intervention (week 12) and at a one-year follow-up (questionnaires only) to identify any changes.

1. ACU Strathfield Exercise Lifestyle Clinic
2. ACU North Sydney ACU Active
3. ACU Blacktown BEST

Simple randomisation with stratification will be implemented after phase 1 (initial baseline testing). This will account for potential confounders such as length of time after delivery (6-16 weeks postpartum), mode of delivery and perineal trauma. Research has shown that the above mentioned variables have significant effects on pelvic floor strength and function.

The exercise intervention will consist of progressive individualized programs for each participant, based off the data collected in their initial assessment. The goals of the exercise program are to.
1. Increase pelvic floor and core strength with Pilates style exercises (e.g. Tzone activation, supine kegels, leg slides, mini crunch, kneeling planks, bird dog, glute bridge)
2. Increase lumbopelvic stability with body weight strength exercises (e.g. reformer feet in straps, crunch in table top, standing kegels, oblique crunch, side plank, scooter on reformer, single leg glute bridge)
3. Progressively increase whole body functional strength with the use of body weight, resistance bands, free weights, and weight machines. (single leg V up, oblique curl on reformer, dead bug, dynamic plank, elevated bird dog, hip thrust, barbell squat and deadlift)
(Please note the above mentioned examples are based off an exercise library developed for this research project and as the exercise prescription is individualised we can not specify exact exercises)

Note: Exercises will only be progressed once the participant is able to perform the required sets and repetitions with the correct form, and report a low RPE (borg 6 - 20 scale). High intensity exercises will not be prescribed until >12 weeks postpartum and you have completed high impact screening exercises.

Evidence based exercises are prescribed by an accredited exercise physiologist that has extensive experience working with the postpartum population. The participants will complete three sessions per week (consisting of 60 minutes each), two will be one to one and face to face in the clinic, and one will consist of a home exercise program delivered via Physitrack. Adherence will be monitored face to face and via physitrack. Participants will also fill out a weekly physical activity questionnaire.
Intervention code [1] 329406 0
Treatment: Other
Comparator / control treatment
Group two – Usual care home exercise
Participants in the control group will not receive the structured 12-week postpartum exercise intervention. Instead, they will receive what is considered "usual care." Usual care involves standard postpartum healthcare practices and advice provided by medical healthcare professionals during routine postnatal care e.g regular health check-ups, education and assessments as provided by your main medical health care provider.
Participants will also be asked to complete a digital physical activity questionnaire every week for 12 weeks via REDcap.
Control group
Active

Outcomes
Primary outcome [1] 339264 0
Symptoms of pelvic floor dysfunction
Timepoint [1] 339264 0
1. Measured pre-intervention (week 1)
2. Measured post - intervention (week 13)
3. Measured at 12 month followup (questionnaire only)
Primary outcome [2] 339265 0
Change in core stabilisation
Timepoint [2] 339265 0
1. Measured pre-intervention (week 1)
2. Measured post- intervention (week 13)
Primary outcome [3] 339266 0
Core strength
Timepoint [3] 339266 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
Secondary outcome [1] 439300 0
Postpartum depression and anxiety
Timepoint [1] 439300 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
3. Measured at 12 month followup
Secondary outcome [2] 439301 0
Lower back pain
Timepoint [2] 439301 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
3. Measured at 12 month followup
Secondary outcome [3] 439302 0
Pelvic girdle pain
Timepoint [3] 439302 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
3. Measured at 12 month followup
Secondary outcome [4] 439776 0
Diastasis recti abdominis muscle (DRAM)
Timepoint [4] 439776 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
Secondary outcome [5] 439777 0
Pelvic floor muscle activity
Timepoint [5] 439777 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
Secondary outcome [6] 439848 0
Lower body strength
Timepoint [6] 439848 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
Secondary outcome [7] 439849 0
Lower body strength
Timepoint [7] 439849 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
Secondary outcome [8] 439850 0
Hip isometric muscle strength
Timepoint [8] 439850 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
Secondary outcome [9] 439851 0
Hip pain
Timepoint [9] 439851 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
Secondary outcome [10] 439852 0
Hip Pain
Timepoint [10] 439852 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
Secondary outcome [11] 439853 0
Hip Pain
Timepoint [11] 439853 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)
Secondary outcome [12] 440163 0
Cardiovascular fitness
Timepoint [12] 440163 0
1. Measured pre-intervention (week 1)
2. Measured post-intervention (week 13)

Eligibility
Key inclusion criteria
Aged over 18 years
Understand written and verbal commands provided in English.
Childbirth in the last 6 to 16 weeks
Attended their 6 week GP or obstetrician maternal health check
Meet the Covid 19 vaccination requirements of ACU and be willing to adhere to all public health orders regarding testing (if still required at the time of the intervention)
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- currently pregnant
- Uncontrolled pulmonary, metabolic, and/or orthopedic conditions that prohibit exercise training

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 an online random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with stratification will be implemented.
This will account for potential confounders such as length of time after delivery (6-16 weeks postpartum), mode of delivery and perineal trauma.
Research has shown that the above-mentioned variables have significant effects on pelvic floor strength and function
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
Demographic data will be tested for normality and presented as mean and standard deviations, medians and interquartile range and percentages where appropriate.
Repeated Measures ANOVA with an effect of time and pairwise comparisons will be used to establish the effect of exercise training on the primary and secondary outcome measures.
One Way Repeated Measures ANOVAs will be used for functional assessment data.
Significance will be taken at p less than 0.05.
Repeated measures analysis of covariance examined Group x Time changes in outcome measures listed above at six weeks, 12 weeks and one year follow up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317311 0
University
Name [1] 317311 0
Australian Catholic University
Country [1] 317311 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 319662 0
None
Name [1] 319662 0
Address [1] 319662 0
Country [1] 319662 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316042 0
ACU Human Research Ethics Committee
Ethics committee address [1] 316042 0
Ethics committee country [1] 316042 0
Australia
Date submitted for ethics approval [1] 316042 0
26/10/2023
Approval date [1] 316042 0
04/12/2023
Ethics approval number [1] 316042 0
2023-3329HC

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

Contacts
Principal investigator
Name 136594 0
Mrs Samantha Jane Walsh
Address 136594 0
The Australian Catholic University, Level 1, 163-167 Albert Rd, Strathfield, NSW 2135
Country 136594 0
Australia
Phone 136594 0
+61 0403128696
Fax 136594 0
Email 136594 0
[email protected]
Contact person for public queries
Name 136595 0
Samantha Jane Walsh
Address 136595 0
The Australian Catholic University. Level 1, 163-167 Albert Rd, Strathfield, NSW 2135
Country 136595 0
Australia
Phone 136595 0
+61 0403128696
Fax 136595 0
Email 136595 0
[email protected]
Contact person for scientific queries
Name 136596 0
Samantha Jane Walsh
Address 136596 0
The Australian Catholic University. Level 1, 163-167 Albert Rd, Strathfield, NSW 2135
Country 136596 0
Australia
Phone 136596 0
+61 0403128696
Fax 136596 0
Email 136596 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
This is a small sample size and we don't want the data to be potentially re-identifiable.
The aggregate data may be made available upon request to the Principle Investigator.


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.