Therapeutische Übungen für die Genesung nach der Geburt (PelviRecover)
Lumbopelvische Stabilisierungsübungen vs. hypopressive Übungen für die postpartale Erholung: Eine randomisierte klinische Studie
Pelvic floor dysfunctions (PFDs) are common conditions that affect women, especially after vaginal childbirth. These disorders can cause urinary or fecal incontinence, pain during sexual activity, and prolapse of pelvic organs, leading to a significant decrease in quality of life. Current scientific evidence shows that early and specific physiotherapy-based interventions after childbirth may help reduce the risk of developing long-term PFDs.
Pelvic floor muscle training (PFMT) is currently the first-line conservative treatment for women with PFD, but in recent years other exercise methods, such as hypopressive exercises, have become increasingly popular, despite limited supporting evidence. At the same time, some women need to return early to physically demanding jobs or impact sports, but there are no clear guidelines on how to safely prepare the abdominopelvic region for progressive exposure to increased intra-abdominal pressure.
This study aims to compare two postpartum recovery exercise programs:
A program based on lumbopelvic stabilization exercises that progressively expose women to increases in intra-abdominal pressure and impact activities.
A program based on hypopressive exercises, which focus on avoiding intra-abdominal pressure.
The goal is to determine which approach is safer and more effective in improving pelvic floor recovery after childbirth and in supporting women in their gradual return to daily, work, and sports activities.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Pelvic floor dysfunctions (PFDs) are highly prevalent conditions that impose a substantial burden on women's health, particularly following vaginal childbirth. Vaginal delivery has been identified as a major risk factor due to potential trauma to the pelvic floor, including overstretching of muscles and nerves, damage to connective tissue supporting pelvic organs, and direct perineal injury. Obstetric interventions such as forceps or vacuum-assisted delivery, episiotomy, and epidural anesthesia may further exacerbate the risk of PFDs. Longitudinal studies indicate that a considerable proportion of women continue to experience urinary or fecal incontinence, dyspareunia, or prolapse for many years after childbirth, highlighting the chronic nature of these dysfunctions and the need for preventive strategies.
Physiotherapy-based interventions have demonstrated promise in reducing the incidence and severity of PFDs when applied early in the postpartum period. Pelvic floor muscle training (PFMT) is considered the gold standard conservative therapy, supported by randomized controlled trials and systematic reviews. PFMT effectively improves muscle strength and function, and its use is endorsed by international guidelines, such as those from the National Institute for Health and Care Excellence (NICE).
In recent years, hypopressive exercises (HE) have been promoted as an alternative or complementary approach to PFMT. HE were originally developed to restore abdominal wall function without provoking increases in intra-abdominal pressure, which is considered a risk factor for pelvic floor overload. Preliminary studies suggest potential benefits in muscle activation and patient satisfaction, yet the quality of evidence remains low, with most research limited to observational designs, small sample sizes, and short follow-up periods. Therefore, the effectiveness and safety of HE in postpartum populations remain uncertain.
Parallel to this, lumbopelvic stabilization exercises (LSE) have been proposed as a means to strengthen the transversus abdominis, multifidus, and pelvic floor muscles through a staged protocol beginning with isometric and coordinated contractions and progressing to integrated functional tasks. Importantly, LSE involve gradual exposure to increased intra-abdominal pressure and impact-related forces, which may facilitate safer return to occupational or athletic activities requiring lifting or high-impact loading. While these exercises have shown benefit in postpartum lumbopelvic pain, there is insufficient evidence on their role in pelvic floor recovery.
Given the growing number of women who resume physically demanding work or impact sports shortly after childbirth, the absence of clear, evidence-based guidelines for abdominopelvic conditioning represents a significant gap in postpartum care. The International Continence Society (ICS) has described PFDs as a "silent epidemic," underlining the urgent need for preventive and rehabilitative interventions supported by rigorous clinical trials.
The present randomized controlled trial is designed to address this gap by directly comparing two structured postpartum rehabilitation approaches: (1) a program of lumbopelvic stabilization exercises incorporating progressive exposure to intra-abdominal pressure and impact, and (2) a program of hypopressive exercises aimed at minimizing intra-abdominal pressure.
This study is expected to generate high-quality evidence regarding the comparative safety and efficacy of these two exercise-based strategies. The findings will provide valuable guidance for clinicians, physiotherapists, and policymakers, contributing to the development of standardized postpartum rehabilitation protocols. Ultimately, the trial seeks to improve long-term pelvic health outcomes and support women in safely returning to their daily, occupational, and athletic activities after childbirth.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Virginia Prieto Gómez, Dr.
- Telefonnummer: +34 918 854 828
- E-Mail: v.prieto@uah.es
Studienorte
-
-
Madrid
-
Alcalá de Henares, Madrid, Spanien, 28805
- Rekrutierung
- Faculty of Nursing and Physiotherapy, University of Alcalá
-
Kontakt:
- Virginia Prieto Gómez, Dr.
- Telefonnummer: +34 918 854 828
- E-Mail: v.prieto@uah.es
-
Kontakt:
- Beatriz Navarro Brazález, Dr.
- Telefonnummer: +34 918 854 828
- E-Mail: b.navarro@uah.es
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria
- Primiparous or multiparous women with an uncomplicated vaginal delivery.
- Women between 6 and 12 weeks postpartum.
- Women who have freely read, understood, and signed the informed consent form.
Exclusion Criteria
- Cesarean delivery.
- Pelvic or perineal pain greater than 4/10 during physical examination.
- Clinical diagnosis of pelvic floor myofascial pain syndrome.
- Evidence of levator ani muscle avulsion.
- Third- or fourth-degree perineal tears.
- History of pelvic surgery.
- History of pelvic fractures and/or pelvic neoplasms.
- Current pregnancy.
- Neurological disorders.
- Active vaginal or urinary tract infections.
- Cognitive, auditory, or visual impairments that limit comprehension, questionnaire completion, consent, or participation in the study.
- Individuals under 18 years of age.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Experimental Group 2: Multimodal Physiotherapy (HE + PFMT + TE)
Hypopressive Exercises & Pelvic Floor Exercises & Therapeutic Education |
The participants will receive Therapeutic Education supported by audiovisual materials covering abdominopelvic anatomy and physiology, common dysfunctions, risk factors, and protective strategies, delivered through 4 face-to-face sessions of 20 minutes over the 8-week intervention period. The participants will attend 8 weekly 45-minute sessions (4 in person at the Research Group laboratory and 4 online via Physitrack®). They will undergo Pelvic Floor Muscle Training guided intravaginally using manometry biofeedback to improve proprioception, strength, endurance, and relaxation, and will perform the exercises at home at least four times per week. Participants will attend 8 weekly 45-minute sessions (4 in person at the Research Group laboratory and 4 online via Physitrack®). They will perform hypopressive exercises under transabdominal ultrasound guidance following the Caufriez method, without voluntary abdominal or pelvic floor contraction, and will perform the exercises at home at least four times per week. |
|
Experimental: Experimental Group 1: Multimodal Physiotherapy (LSE + PFMT + TE)
Lumbopelvic Stabilization Exercises & Pelvic Floor Exercises & Therapeutic Education |
The participants will receive Therapeutic Education supported by audiovisual materials covering abdominopelvic anatomy and physiology, common dysfunctions, risk factors, and protective strategies, delivered through 4 face-to-face sessions of 20 minutes over the 8-week intervention period. The participants will attend 8 weekly 45-minute sessions (4 in person at the Research Group laboratory and 4 online via Physitrack®). They will undergo Pelvic Floor Muscle Training guided intravaginally using manometry biofeedback to improve proprioception, strength, endurance, and relaxation, and will perform the exercises at home at least four times per week. Participants will attend 8 weekly 45-minute sessions (4 in person at the Research Group laboratory and 4 online via Physitrack®). They will perform lumbopelvic stabilization exercises guided by transabdominal ultrasound to ensure correct activation of trunk stabilizing muscles, primarily the transversus abdominis and pelvic floor muscles. Exercises will emphasize coordination of the lumbar multifidus, transversus abdominis, and pelvic floor across different positions, progressing to dynamic tasks involving additional lumbopelvic muscles, light weight lifting, and controlled impact activities such as jump squats. Participants perform the exercises at home at least four times per week. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Health-related quality of life (HRQoL)
Zeitfenster: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
Self-administration of the PFDI-20 questionnaire, which evaluates urogenital, anorectal, and prolapse-related symptoms. Each subscale ranges from 0 to 100, with lower scores indicating better quality of life (less symptom distress). |
Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sexual function
Zeitfenster: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
Self-administration of the Female Sexual Function Index (FSFI), which assesses sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total score ranges from 2 to 36. A cutoff score of <27 is commonly used to indicate sexual dysfunction |
Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
|
Physical activity level
Zeitfenster: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
Self-administration of the International Physical Activity Questionnaire (IPAQ). This instrument estimates weekly physical activity based on energy expenditure expressed in MET·min/week, taking into account the frequency, duration, and intensity of the activities performed. It classifies individuals into three categories: low (inactive), moderate, or high. |
Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
|
Urogenital hiatus distance
Zeitfenster: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
2D transperineal ultrasound (Mindray M7, Shenzhen, China): sagittal plane, measuring the distance between the inferior margin of the pubic symphysis and the anorectal angle. Measurements will be obtained at rest and during maximal pelvic floor muscle contraction. |
Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
|
Pelvic floor muscle tone and strength
Zeitfenster: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
Vaginal dynamometry (Pelvimetre, Phenix Vivaltis, Montpellier, France): in the lithotomy position, resting tone will be recorded as the lowest value obtained with the pelvic floor muscles relaxed, and strength will be determined as the mean of three maximal voluntary contractions. |
Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
|
Perceived self-efficacy
Zeitfenster: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
Self-administration of the Broome Pelvic Muscle Self-Efficacy Scale: this instrument evaluates self-efficacy expectations regarding the performance of specific pelvic floor muscle exercises and the anticipated outcomes. The maximum score is 100, indicating high self-efficacy, while scores below 33 reflect low self-efficacy. |
Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
|
Functional capacity
Zeitfenster: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
30-Second Sit-to-Stand Test: records the total number of complete repetitions of standing up from and sitting down on a standard armless chair, with the arms crossed over the chest, performed within a 30-second interval. |
Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Treatment safety
Zeitfenster: After each weekly session during the 8-week intervention (Weeks 1-8); immediately post-intervention (V1, Week 8); 3 months (V2), 6 months (V3), and 12 months (V4) post-intervention.
|
All adverse events occurring during the intervention period will be recorded, including the onset of pain, medical consultations related to the treatment, medication use, postponement of sessions due to treatment-related issues, or withdrawal from the intervention. |
After each weekly session during the 8-week intervention (Weeks 1-8); immediately post-intervention (V1, Week 8); 3 months (V2), 6 months (V3), and 12 months (V4) post-intervention.
|
|
Satisfaction level
Zeitfenster: Immediately after completing the intervention (V1)
|
Verbal numerical scale ranging from 0 to 10, where 0 indicates complete dissatisfaction with the treatment and 10 represents excellent satisfaction. |
Immediately after completing the intervention (V1)
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CEIP/2025/3/069
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Individual participant data will not be made available due to privacy and ethical restrictions. Aggregated study results will be published in peer-reviewed journals and may be shared upon reasonable request.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .