Therapeutic Exercise for Postpartum Recovery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alcala

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Therapeutic Education (TE)

    Behavioral

    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 intervention

    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 intervention

    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 intervention

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Experimental Group 2: Multimodal Physiotherapy (HE + PFMT + TE)Experimental treatment 3 interventions
Group B: Experimental Group 1: Multimodal Physiotherapy (LSE + PFMT + TE)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

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).

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

Secondary outcomes

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

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

1

Treatment safety

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.

Time frame
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.
2

Satisfaction level

Verbal numerical scale ranging from 0 to 10, where 0 indicates complete dissatisfaction with the treatment and 10 represents excellent satisfaction.

Time frame
Immediately after completing the intervention (V1)

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