POSH-Ex: Physiotherapist-Led Telerehabilitation Exercise Programme for Postpartum Sexual Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity Medical Centre Ljubljana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • POSH-Ex (Postpartum Sexual Health Exercise)

    Behavioral

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: POSH-Ex (Postpartum Sexual Health Exercise)Experimental treatment 1 intervention
Group B: Control Arm POSH-ExNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in female sexual function

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

Secondary outcomes

1

Change in physical activity

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
2

Change in fatigue

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
3

Change in depressive symptoms

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.

Time frame
Baseline and after the 12-weeks

Other outcomes

Sponsors and contacts

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