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

NCT07747285 | Not Yet Recruiting

• 1 other identifier: POSH-EX-2026-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Depression; Fatigue; Physical Activity; Postpartum Sexual Dysfunction

Keywords

postpartum; Postpartum rehabilitation; Postpartum sexual health; Female sexual function; Pelvic floor muscle training; Telerehabilitation; Exercise; POSH-Ex

Outcome Measures

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.

  Baseline and after the 12-weeks

Secondary Outcomes (3)

• Change in physical activity

  Baseline and after the 12-weeks

• Change in fatigue

  Baseline and after the 12-weeks

• Change in depressive symptoms

  Baseline and after the 12-weeks

Study Arms (2)

POSH-Ex (Postpartum Sexual Health Exercise)

EXPERIMENTAL

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.

Behavioral: POSH-Ex (Postpartum Sexual Health Exercise)

Control Arm POSH-Ex

NO INTERVENTION

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.

Interventions

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.

POSH-Ex (Postpartum Sexual Health Exercise)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Health Centers of Croatia

Varaždin, 42000, Croatia

Location

MeSH Terms

Conditions

Depression, Postpartum; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Nikolina Zaplatić Degač

CONTACT

+385989362968; nzaplatic@unin.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, blinding of participants and the treating physiotherapist is not feasible. To minimize potential bias, randomization will be performed only after completion of all baseline assessments using a computer-generated allocation sequence prepared by third person not related to the study. Outcome assessors will be blinded to participants allocation. Outcome measures consist of standardized validated self-administered questionnaires completed electronically according to predefined procedures. Statistical analyses will be performed by an independent statistician using anonymized datasets with coded treatment groups in accordance with the predefined statistical analysis plan.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the experimental group receiving the POSH-Ex (Postpartum Sexual Health Exercise) programme or the control group receiving usual postpartum care. The study uses a parallel-group design in which participants remain in their allocated group throughout the 12-week intervention period. Outcome assessments will be performed at baseline and immediately after completion of the intervention. If necessary, participant recruitment and intervention delivery will be conducted in consecutive cohorts while maintaining identical eligibility criteria, randomization procedures, intervention protocols, outcome assessment schedules, and data collection methods across all cohorts.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Locations

CR (1)