POSH-Ex: Physiotherapist-Led Telerehabilitation Exercise Programme for Postpartum Sexual Health (POSH-Ex)
POSH-Ex: Randomized Controlled Trial Evaluating a Standardized Physiotherapist-Led Telerehabilitation Programme for Postpartum Sexual Health
Postpartum women frequently experience impairments in sexual function, pelvic floor dysfunction, fatigue, and depressive symptoms, all of which may adversely affect their quality of life during the postpartum period. Although pelvic floor muscle training is recommended as part of postpartum rehabilitation, evidence regarding comprehensive physiotherapist-led exercise programmes specifically targeting postpartum sexual health remains limited. Furthermore, no standardized telerehabilitation programme has yet been evaluated using a randomized controlled trial design.
The aim of this randomized controlled trial is to evaluate the effectiveness of the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized 12-week physiotherapist-led telerehabilitation intervention designed to improve female sexual function and overall postpartum health after childbirth. Secondary objectives are to evaluate its effects on pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition.
A total of 84 postpartum women will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will complete supervised online exercise sessions twice weekly for 12 weeks, while participants in the control group will receive usual postpartum care. Outcome assessments will be performed at baseline and immediately after completion of the intervention.
The primary outcome is female sexual function assessed using the Female Sexual Function Index (FSFI). Secondary outcomes include pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. The findings are expected to provide high-quality evidence regarding the effectiveness of a standardized telerehabilitation programme for postpartum rehabilitation and may contribute to the development of evidence-based postpartum rehabilitation programmes and future clinical practice guidelines.
Study Overview
Status
Intervention / Treatment
Detailed Description
Postpartum sexual health is an important yet frequently neglected component of maternal health. During the postpartum period, women undergo substantial physiological, musculoskeletal, hormonal, and psychosocial changes that may negatively affect sexual function, pelvic floor function, physical activity, psychological well-being, and overall quality of life. Female sexual dysfunction following childbirth is common and is influenced by multiple interrelated factors, including pelvic floor muscle impairment, perineal trauma, fatigue, depressive symptoms, breastfeeding, and reduced physical activity. Despite its high prevalence, postpartum sexual health remains insufficiently addressed within routine postpartum care.
Pelvic floor muscle training is widely recommended for postpartum rehabilitation and has demonstrated beneficial effects on pelvic floor function and urinary continence. However, existing exercise interventions have primarily focused on isolated pelvic floor muscle exercises or single treatment components, while comprehensive physiotherapist-led exercise programmes specifically targeting postpartum sexual health remain scarce. Furthermore, the increasing availability of digital health technologies has highlighted the potential of telerehabilitation to improve accessibility and continuity of postpartum physiotherapy services. To the best of our knowledge, no standardized physiotherapist-led telerehabilitation programme specifically developed to improve postpartum sexual health has previously been evaluated in a randomized controlled trial.
The present study will evaluate the effectiveness of the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized physiotherapist-led telerehabilitation intervention developed to improve female sexual function and overall postpartum health. The programme integrates pelvic floor muscle training with breathing control, deep core muscle activation, functional strengthening exercises, balance training, mobility exercises, and progressive whole-body exercise performed under physiotherapist supervision using an online platform. The intervention has been designed to provide a structured, progressive, and clinically applicable rehabilitation programme suitable for postpartum women.
This study is designed as a parallel-group randomized controlled trial. A total of 84 postpartum women meeting the predefined eligibility criteria will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants allocated to the intervention group will participate in the 12-week POSH-Ex programme consisting of two supervised online exercise sessions per week (60 minutes per session), while participants allocated to the control group will receive usual postpartum care without the structured exercise programme. Participant recruitment will continue until the planned sample size has been achieved and, if necessary, the intervention will be delivered in consecutive cohorts while maintaining identical eligibility criteria, randomization procedures, intervention protocol, supervision procedures, outcome assessment schedule, and data collection methods for all participants.
The primary objective is to determine whether participation in the POSH-Ex programme improves female sexual function compared with usual postpartum care. Female sexual function will be assessed using the Female Sexual Function Index (FSFI). Secondary objectives are to evaluate the effects of the intervention on pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. Outcome assessments will be performed at baseline before randomization and immediately following completion of the 12-week intervention.
The study has been designed in accordance with current methodological recommendations for randomized controlled trials. Randomization procedures, participant safety monitoring, adverse event reporting, data management, and statistical analyses have been prospectively defined within the study protocol to ensure methodological rigor, transparency, and reproducibility.
The findings of this trial are expected to provide high-quality evidence regarding the effectiveness of a standardized physiotherapist-led telerehabilitation programme for postpartum rehabilitation. If effective, the POSH-Ex programme may contribute to improving evidence-based physiotherapy practice, facilitate wider implementation of telerehabilitation in postpartum care, and support the development of future clinical guidelines for postpartum rehabilitation and women's health.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nikolina Zaplatić Degač
- Phone Number: +385989362968
- Email: nzaplatic@unin.hr
Study Locations
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Varaždin, Croatia, 42000
- Health Centers of Croatia
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Contact:
- Nikolina Zaplatić Degač
- Phone Number: +385989362968
- Email: nzaplatic@unin.hr
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Contact:
- Email: nzaplatic@unin.hr
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Principal Investigator:
- Nikolina Zaplatić Degač
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18 to 45 years.
- Between 10 and 12 weeks postpartum at the time of enrolment.
- Singleton live birth.
- Ability to understand and communicate in the Croatian language.
- Ability to participate safely in moderate-intensity exercise.
- Access to a computer, tablet, or smartphone with a stable internet connection for participation in online exercise sessions.
- Willingness to comply with the study protocol and attend supervised exercise sessions.
- Provision of written informed consent.
Exclusion Criteria:
• Medical contraindications to exercise according to current clinical recommendations.
- Pregnancy during the study period.
- Severe musculoskeletal, neurological, cardiovascular, or other medical conditions preventing safe participation in exercise.
- Current participation in another structured postpartum rehabilitation or exercise programme.
- Severe psychiatric disorder requiring immediate specialist treatment.
- Positive response to Item 10 of the Edinburgh Postnatal Depression Scale indicating current thoughts of self-harm. Such participants will be referred for appropriate clinical assessment before potential study participation.
- Inability to complete study questionnaires or follow study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: POSH-Ex (Postpartum Sexual Health Exercise)
Participants allocated to the intervention group will receive the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized physiotherapist-led telerehabilitation intervention delivered over 12 weeks.
The programme consists of two supervised online exercise sessions per week (approximately 60 minutes per session) conducted according to a predefined standardized protocol.
Participants will additionally receive weekly written exercise materials supporting independent practice between supervised sessions.
|
POSH-Ex is a standardized physiotherapist-led telerehabilitation programme designed to improve female sexual function and overall postpartum health.
The intervention integrates pelvic floor muscle training, breathing control, deep core activation, functional strengthening, balance training, mobility exercises, and progressive whole-body exercises delivered through live online sessions.
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No Intervention: Control Arm POSH-Ex
Participants allocated to the control group will receive usual postpartum care routinely available within the Croatian healthcare system.
They will not receive the structured POSH-Ex exercise programme during the study period.
Outcome assessments will be performed according to the same schedule as in the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in female sexual function
Time Frame: Baseline and after the 12-weeks
|
Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated 19-item self-administered questionnaire evaluating six domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Total scores range from 2 to 36, with higher scores indicating better sexual function.
The primary outcome will be the change in the total FSFI score from baseline to the end of the 12-week intervention.
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Baseline and after the 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical activity
Time Frame: Baseline and after the 12-weeks
|
Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Total physical activity and activity by intensity level will be calculated according to the official IPAQ scoring protocol and expressed as MET-minutes per week.
The secondary outcome will be the change in physical activity from baseline to the end of the intervention.
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Baseline and after the 12-weeks
|
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Change in fatigue
Time Frame: Baseline and after the 12-weeks
|
Fatigue will be assessed using the Fatigue Assessment Scale (FAS), a validated 10-item questionnaire measuring physical and mental fatigue.
Total scores range from 10 to 50, with higher scores indicating greater fatigue.
The secondary outcome will be the change in fatigue scores from baseline to the end of the intervention.
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Baseline and after the 12-weeks
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Change in depressive symptoms
Time Frame: Baseline and after the 12-weeks
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Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a validated 10-item questionnaire designed to screen for postpartum depressive symptoms.
Higher scores indicate greater severity of depressive symptoms.
The secondary outcome will be the change in EPDS scores from baseline to the end of the intervention.
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Baseline and after the 12-weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- POSH-EX-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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