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

2026年7月30日 更新者:University Medical Centre Ljubljana

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

84

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Nikolina Zaplatić Degač
  • 電話番号:+385989362968
  • メール:nzaplatic@unin.hr

研究場所

      • Varaždin、クロアチア、42000
        • Health Centers of Croatia
        • コンタクト:
          • Nikolina Zaplatić Degač
          • 電話番号:+385989362968
          • メール:nzaplatic@unin.hr
        • コンタクト:
        • 主任研究者:
          • Nikolina Zaplatić Degač

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in female sexual function
時間枠: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.
Baseline and after the 12-weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in physical activity
時間枠: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.
Baseline and after the 12-weeks
Change in fatigue
時間枠: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.
Baseline and after the 12-weeks
Change in depressive symptoms
時間枠: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.
Baseline and after the 12-weeks

協力者と研究者

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年8月31日

研究の完了 (推定)

2027年9月30日

試験登録日

最初に提出

2026年7月30日

QC基準を満たした最初の提出物

2026年7月30日

最初の投稿 (実際)

2026年8月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月5日

QC基準を満たした最後の更新が送信されました

2026年7月30日

最終確認日

2026年7月1日

詳しくは

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いいえ

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