Health Centers of Croatia
Varaždin, 42000, Croatia
Location contact
Nikolina Zaplatić Degač
CONTACT
Nikolina Zaplatić Degač
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07747285
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
Varaždin, 42000, Croatia
Nikolina Zaplatić Degač
CONTACT
Nikolina Zaplatić Degač
PRINCIPAL_INVESTIGATOR
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Baseline and after the 12-weeks
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.
Contact information is provided by the study sponsor or research team.
University Medical Centre Ljubljana
Other
POSH-Ex: Randomized Controlled Trial Evaluating a Standardized Physiotherapist-Led Telerehabilitation Programme for Postpartum Sexual Health
Acronym: POSH-Ex
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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