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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001237471
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/07/2025
Date registered
Help: Date registered
6/11/2025
Date last updated
Help: Date last updated
6/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
6/11/2025
Type of registration
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Prospectively registered

Titles & IDs
Public title
The impact of training using the Bebo® method and assisted by the Winner Flow v2.0 whistle in women after vaginal delivery on pelvic floor muscle function and diastasis recti
Scientific title
The Impact of Bebo® Method Training Combined with Winner Flow v2.0 Assistance on Pelvic Floor Muscle Function and Rectus Abdominis Diastasis in Postpartum Women Following Vaginal Delivery
Additional trial identifiers [1] 314875 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Pelvic floor dysfunction 338153 0
diastasis recti abdominis 338154 0
Urinary incontinence 338155 0
Condition category
Condition code
Reproductive Health and Childbirth 334437 334437 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure

The study will include 60 women aged 25 to 35 years who are 6 to 7 weeks postpartum following their first vaginal delivery. To assess the effectiveness of the intervention, all participants will undergo a comprehensive evaluation before and after the 4-week intervention period.

The assessments will include:

Completion of the UDI-6 (Urogenital Distress Inventory) to evaluate urinary continence status,

Measurement of pelvic floor neuromuscular activity using surface electromyography (EMG),

Evaluation of rectus abdominis diastasis using ultrasound imaging (USG),

Assessment of balance and plantar pressure distribution using the FreeMed Base pedobarographic platform,

Analysis of pelvic alignment with the Duometr OP-1/P inclinometer, and

Measurement of spinal and hip joint mobility using a goniometer.

Participants
A total of 60 women, aged 25 to 35 years, will be enrolled. All participants must be 6–7 weeks postpartum following their first vaginal delivery, and provide a medical clearance certificate confirming no contraindications to physical activity or study participation.

Group Allocation and Intervention
Participants will be randomly assigned into one of three study arms using a computer-generated random number sequence:

Group 1: BeBo® Training Group
Participants will undergo a 4-week individualized pelvic floor training program based on the BeBo® concept. Sessions will be conducted twice per week, under the supervision of a qualified physiotherapist.

Group 2: BeBo® + Winner Flow Group
This group will receive the same individualized 4-week BeBo® training program, with each session supported by the use of the Winner Flow v2.0 breathing device. Training sessions will also take place twice weekly, under the supervision of a trained therapist.

The Winner Flow v2.0 is designed to promote controlled exhalation and intra-abdominal pressure modulation, thereby facilitating optimal pelvic floor muscle activation during exercise.

BeBo® Training Protocol
Each training session will consist of a 10-minute theoretical component and a 50-minute practical component. The program is classified as low-intensity according to the Borg scale. Each participant will maintain an exercise diary; more than one absence will result in exclusion from the program.

The practical component will include:

awareness, strengthening, and mobilization exercises,

relaxation exercises aimed at restoring autonomic balance and reducing stress,

integration of pelvic floor muscles into daily activities through posture correction, breathing, and balance training.

Exercises will be performed in various starting positions (standing, quadruped, knee–elbow, sitting, supine, side-lying, prone) with the use of simple equipment (large and small exercise balls, sensorimotor disk, foam roller, tennis ball, cherry pit bags).

BeBo® Training with the Winner Flow v2.0
The modification consists of exhalation during deep muscle activation exercises through the Winner Flow v2.0 resistance device. Each participant places the mouthpiece in the mouth and exhales against resistance individually adjusted during the first session. Inhalation is performed through the nose, while exhalation is performed through the mouth.

Procedure for Adjusting Resistance with the Winner Flow v2.0
In accordance with the device protocol, resistance is individually adjusted for each participant. While in a supine position with hips flexed at 45°, the participant performs a 10-second exhalation through the mouthpiece, initially set at level “1.” If exhalation lasts less than 4–5 seconds, resistance is reduced; if the target duration is easily achieved, resistance is increased. The resistance level is considered appropriate when a regular 10-second exhalation is achieved without excessive isometric contraction of the abdominal wall.

As part of monitoring adherence to the intervention, an attendance list will be maintained and checked at each session. One absence during the entire cycle will be permitted. If this limit is exceeded, the participant will not be able to continue in the project
Intervention code [1] 331479 0
Treatment: Other
Intervention code [2] 331824 0
Rehabilitation
Description of the comparator or control
Participants in this group (n = 20) will not receive any therapeutic intervention during the 4-week period and will serve as a non-intervention control. They will undergo only a follow-up assessment 4 weeks after the baseline evaluation.
Control group
Active

Outcomes
Primary outcome [1] 342132 0
pelvic floor muscles
Timepoint [1] 342132 0
The procedure will be conducted for the first time at patient enrolment (i.e., 6 -7 weeks postpartum) and repeated 4 weeks after the initial assessment. At each visit, pelvic floor muscles will be evaluated as the first outcome measure.
Primary outcome [2] 342133 0
Symptoms of urinary incontinence using the Urinary Distress Inventory, Short Form (UDI-6)
Timepoint [2] 342133 0
The procedure will be conducted for the first time at patient enrolment (i.e., 6 -7 weeks postpartum) and repeated 4 weeks after the initial assessment. Following the EMG assessment, the participant will complete a brief (approximately 2-minute) questionnaire regarding urinary incontinence.
Secondary outcome [1] 449718 0
Rectus abdominis diastasis
Timepoint [1] 449718 0
The procedure will be conducted for the first time at patient enrolment (i.e., 6-7 weeks postpartum) and repeated 4 weeks after the initial assessment. Following the completion of a brief (approximately 2-minute) questionnaire on urinary incontinence, an ultrasound examination of the rectus abdominis diastasis will be performed.
Secondary outcome [2] 449719 0
Range of motion (ROM) of the hip joints
Timepoint [2] 449719 0
The procedure will be conducted for the first time at patient enrolment (i.e., 6-7 weeks postpartum) and repeated 4 weeks after the initial assessment. Following the ultrasound examination of rectus abdominis diastasis, an assessment of hip joint mobility will be performed.
Secondary outcome [3] 449720 0
Range of motion (AROM) of the lumbar spine
Timepoint [3] 449720 0
The procedure will be conducted for the first time at patient enrolment (i.e., 6-7 weeks postpartum) and repeated 4 weeks after the initial assessment. The examination will be performed following the assessment of hip joint mobility.
Secondary outcome [4] 449721 0
Pelvic tilt angle in the sagittal and frontal planes
Timepoint [4] 449721 0
The procedure will be conducted for the first time at patient enrolment (i.e., 6-7 weeks postpartum) and repeated 4 weeks after the initial assessment. The examination will be performed following the assessment of spinal mobility.
Secondary outcome [5] 449722 0
Assessment of Balance
Timepoint [5] 449722 0
The procedure will be conducted for the first time at patient enrolment (i.e., 6-7 weeks postpartum) and repeated 4 weeks after the initial assessment. The examination will be performed following the assessment of pelvic alignment.
Secondary outcome [6] 453689 0
Load Distribution
Timepoint [6] 453689 0
The procedure will be conducted for the first time at patient enrolment (i.e., 6–7 weeks postpartum) and repeated 4 weeks after the initial assessment. The examination will be performed following the assessment of balance.

Eligibility
Key inclusion criteria

Female sex,
Age between 25 and 35 years,
Primiparous (first childbirth),
Singleton pregnancy,
Physiological (uncomplicated) course of pregnancy,
Qualification for the study between the 6th and 7th week postpartum following vaginal delivery,
Written informed consent to participate in the study free of charge,
Medical certificate confirming no contraindications to participate in the assessment procedures.
Minimum age
25 Years
Maximum age
35 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Lack of a medical certificate authorizing participation in the study,
Absence of written informed consent,
Multiple pregnancy,
History of more than one childbirth,
Postpartum complications such as: separation of the pubic symphysis or sacroiliac joints, thrombophlebitis, third- or fourth-degree perineal tear, prior abdominal or gynecological surgery,
Orthopedic conditions (e.g., spinal surgery, fractures in the pelvic or spinal region),
Pelvic organ prolapse grade III or IV,
Lower urinary tract or vaginal infections,
Sensory disturbances in the perineal region,
Endometriosis,
Other health conditions including: thyroid disorders, diabetes, overweight or obesity, cancer, rheumatic diseases, respiratory diseases, neurological disorders, cognitive impairments that prevent cooperation, psychiatric disorders, depression, or other neurological conditions.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 27205 0
Poland
State/province [1] 27205 0
malopolska

Funding & Sponsors
Funding source category [1] 319431 0
University
Name [1] 319431 0
University of Physical Education in Krakow
Country [1] 319431 0
Poland
Primary sponsor type
Individual
Name
Ph.D. Paulina Handzlik-Waszkiewicz, Academy of Physical Culture (AKF)
Address
Country
Poland
Secondary sponsor category [1] 321921 0
Individual
Name [1] 321921 0
Prof. Agnieszka Suder, Academy of Physical Culture (AKF)
Address [1] 321921 0
Country [1] 321921 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318002 0
The Ethical Committee of Regional Medical Chamber in Krakow, Poland
Ethics committee address [1] 318002 0
Ethics committee country [1] 318002 0
Poland
Date submitted for ethics approval [1] 318002 0
Approval date [1] 318002 0
20/05/2025
Ethics approval number [1] 318002 0

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

Contacts
Principal investigator
Name 142842 0
Dr Paulina Handzlik-Waszkiewicz
Address 142842 0
University of Physical Education in Kraków al. Jana Pawla II 78, 31-571 Kraków, Kraków, Poland
Country 142842 0
Poland
Phone 142842 0
+48512803119
Fax 142842 0
Email 142842 0
[email protected]
Contact person for public queries
Name 142843 0
Paulina Handzlik-Waszkiewicz
Address 142843 0
University of Physical Education in Kraków al. Jana Pawla II 78, 31-571 Kraków, Kraków, Poland
Country 142843 0
Poland
Phone 142843 0
+48512803119
Fax 142843 0
Email 142843 0
[email protected]
Contact person for scientific queries
Name 142844 0
Paulina Handzlik-Waszkiewicz
Address 142844 0
University of Physical Education in Kraków al. Jana Pawla II 78, 31-571 Kraków, Kraków, Poland
Country 142844 0
Poland
Phone 142844 0
+48512803119
Fax 142844 0
Email 142844 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: It is forbidden due to country law



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.