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临床试验/NCT07747285
NCT07747285尚未招募不适用

POSH-Ex: Randomized Controlled Trial Evaluating a Standardized Physiotherapist-Led Telerehabilitation Programme for Postpartum Sexual Health

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
84
试验地点
1
主要终点
Change in female sexual function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • • 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.

研究组 & 干预措施

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.

干预措施: POSH-Ex (Postpartum Sexual Health Exercise) (Behavioral)

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.

结局指标

主要结局

Change in female sexual function

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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