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Postpartum PeriodPelviRecoverNCT07313683

Therapeutic Exercise for Postpartum Recovery

A study testing Therapeutic Education (TE), Pelvic Floor Exercises (PFMT) and Lumbopelvic Stabilization Exercises (LSE) in people with Postpartum Period and Pelvic Floor Disorders, run by University of Alcala at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Postpartum Period, Pelvic Floor Disorders
What is being tested?
Therapeutic Education (TE), Pelvic Floor Exercises (PFMT) and Lumbopelvic Stabilization Exercises (LSE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteSpain
Study dates
15 May 2026to Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Virginia Prieto Gómez, Dr. contact

+34 918 854 828

v.prieto@uah.es

Spain1 site, 1 recruiting
  • Faculty of Nursing and Physiotherapy, University of Alcalá

    Alcalá de Henares, Madrid, 28805

    Virginia Prieto Gómez, Dr., +34 918 854 828, v.prieto@uah.es

    Beatriz Navarro Brazález, Dr., +34 918 854 828, b.navarro@uah.es

    Recruiting

Other trials in Spain

About this study

Official title: Lumbopelvic Stabilization Exercises vs. Hypopressive Exercises for Postpartum Recovery: A Randomized Clinical Trial

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.

Read more

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.

Read the detailed description

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.

Being tested
Therapeutic Education (TE), Pelvic Floor Exercises (PFMT), Lumbopelvic Stabilization Exercises (LSE), Hypopressive Exercises (HE)
Keywords
Therapeutic exercise, Physical therapy, Intra-abdominal pressure, Pelvic floor, Postpartum period, Quality of life
Medical subject headings
Pelvic Floor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic Education (TE)Behavioural

    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.

  • Pelvic Floor Exercises (PFMT)Other

    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.

  • Lumbopelvic Stabilization Exercises (LSE)Other

    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.

  • Hypopressive Exercises (HE)Other

    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.

Study groups in NCT07313683
Study groupRoleWhat they receive
Experimental Group 2: Multimodal Physiotherapy (HE + PFMT + TE)ExperimentalHypopressive Exercises \& Pelvic Floor Exercises \& Therapeutic Education
Receives: Behavioral: Therapeutic Education (TE); Other: Pelvic Floor Exercises (PFMT); Other: Hypopressive Exercises (HE)
Experimental Group 1: Multimodal Physiotherapy (LSE + PFMT + TE)ExperimentalLumbopelvic Stabilization Exercises \& Pelvic Floor Exercises \& Therapeutic Education
Receives: Behavioral: Therapeutic Education (TE); Other: Pelvic Floor Exercises (PFMT); Other: Lumbopelvic Stabilization Exercises (LSE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-related quality of life (HRQoL)

    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).

    Measured: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.

Secondary outcomes (6)
  1. Sexual function

    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

    Measured: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.

  2. Physical activity level

    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.

    Measured: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.

  3. Urogenital hiatus distance

    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.

    Measured: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.

  4. Pelvic floor muscle tone and strength

    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.

    Measured: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.

  5. Perceived self-efficacy

    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.

    Measured: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.

  6. Functional capacity

    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.

    Measured: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2026
  2. Study start15 May 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07313683
Sponsor's protocol ID
CEIP/2025/3/069
Acronym
PelviRecover
Status last verified
Dec 2025
First submitted
17 Nov 2025
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Education (TE), Pelvic Floor Exercises (PFMT) and Lumbopelvic Stabilization Exercises (LSE) in people with Postpartum Period and Pelvic Floor Disorders, run by University of Alcala at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Virginia Prieto Gómez, Dr. (+34 918 854 828, v.prieto@uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (HRQoL) (time frame: Baseline (V0); immediately after completing the intervention (V1); 3 months (V2); 6 months (V3); and 12 months (V4) after intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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