Therapeutic Exercise for Postpartum Recovery

NCT07313683 | Not Yet Recruiting

• 1 other identifier: CEIP/2025/3/069
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postpartum Period; Pelvic Floor Disorders

Keywords

Therapeutic exercise; Physical therapy; Intra-abdominal pressure; Pelvic floor; Postpartum period; Quality of life

Outcome Measures

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).

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

Secondary Outcomes (6)

• Sexual function

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

• Physical activity level

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

• Urogenital hiatus distance

  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

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

• Perceived self-efficacy

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

Other Outcomes (2)

• Treatment safety

  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

  Immediately after completing the intervention (V1)

Study Arms (2)

Experimental Group 2: Multimodal Physiotherapy (HE + PFMT + TE)

EXPERIMENTAL

Hypopressive Exercises \& Pelvic Floor Exercises \& Therapeutic Education

Behavioral: Therapeutic Education (TE); Other: Pelvic Floor Exercises (PFMT); Other: Hypopressive Exercises (HE)

Experimental Group 1: Multimodal Physiotherapy (LSE + PFMT + TE)

EXPERIMENTAL

Lumbopelvic Stabilization Exercises \& Pelvic Floor Exercises \& Therapeutic Education

Behavioral: Therapeutic Education (TE); Other: Pelvic Floor Exercises (PFMT); Other: Lumbopelvic Stabilization Exercises (LSE)

Interventions

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.

Experimental Group 1: Multimodal Physiotherapy (LSE + PFMT + TE); Experimental Group 2: Multimodal Physiotherapy (HE + PFMT + TE)

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.

Experimental Group 1: Multimodal Physiotherapy (LSE + PFMT + TE); Experimental Group 2: Multimodal Physiotherapy (HE + PFMT + TE)

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.

Experimental Group 1: Multimodal Physiotherapy (LSE + PFMT + TE)

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.

Experimental Group 2: Multimodal Physiotherapy (HE + PFMT + TE)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals whose biological sex is female are eligible to participate, as the study involves postpartum women. Eligibility is based on having experienced childbirth, regardless of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Faculty of Nursing and Physiotherapy, University of Alcalá

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

Virginia Prieto Gómez, Dr.

CONTACT

+34 918 854 828; v.prieto@uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator responsible for participant randomization and the statistician performing the data analysis will be masked to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 2, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)