Adapted Physical Activity and Pelvic Floor Function for Pelvic Girdle Pain During Pregnancy

NCT07186504 | Not Yet Recruiting

• 1 other identifier: 2025-01561
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pelvic girdle pain (PGP) is a common condition during pregnancy, affecting up to two-thirds of women. It can cause significant discomfort, limit daily activities, and reduce quality of life. Current treatment options are limited, and many women continue to experience pain throughout pregnancy and even after childbirth. This study will evaluate whether a structured program of adapted physical activity, with additional individualized pelvic floor rehabilitation when needed, can reduce pelvic girdle pain and improve function during pregnancy. The intervention consists of weekly 60-minute sessions of adapted physical activity, led by a pelvic health physiotherapist, from inclusion until 36-38 weeks of gestation. The exercises focus on lumbopelvic stability, mobility, strengthening, and safe aerobic activity. If a participant presents with pelvic floor dysfunction, individualized rehabilitation may be added in parallel. Participants will be randomly assigned to either the intervention group (adapted physical activity ± pelvic floor rehabilitation) or a control group. The control group will receive standard pregnancy follow-up care plus a validated flyer with international recommendations on physical activity during pregnancy but without supervised sessions. The primary outcomes are pain intensity and functional impact of PGP, measured using the Visual Analog Scale (VAS) and the Pelvic Girdle Questionnaire (PGQ). Secondary outcomes include self-reported physical activity, pelvic symptoms, pelvic floor function, adherence to the intervention, and acceptability of the program. A total of 40 pregnant women will be enrolled at Hospital La Tour in Geneva, Switzerland. Assessments will take place at three time points: inclusion (≤27 weeks of gestation), late pregnancy (36-38 weeks), and 3 months after delivery. The study is expected to provide new evidence on the benefits of integrating pelvic floor functionality into physical activity programs for pregnant women with PGP. If effective, this approach could inform clinical practice and improve care for women during pregnancy

Conditions

Pelvic Girdle Pain; Pregnancy; Pelvic Floor Dysfunctions

Keywords

Pregnancy-related pelvic girdle pain; Prenatal pelvic pain; Pelvic floor function; Pelvic floor rehabilitation; Adapted physical activity; Prenatal exercise; Physiotherapy in pregnancy; Prenatal musculoskeletal pain; Maternal health; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Pain Intensity (Visual Analog Scale, VAS)

  Pain intensity related to pelvic girdle pain measured on a 10 cm Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).

  Baseline (≤27 weeks gestation), 36-38 weeks gestation and 3 months postpartum.

• Functional Impact of Pelvic Girdle Pain (Pelvic Girdle Questionnaire, PGQ)

  Functional disability and symptoms assessed with the 25-item Pelvic Girdle Questionnaire (PGQ, score range 0-100; higher scores indicate greater disability).

  Baseline, Gestational Weeks 36-38 and 3 months postpartum.

Secondary Outcomes (5)

• Physical Activity (Pregnancy Physical Activity Questionnaire, PPAQ)

  Baseline, Gestational Weeks 36-38 and 3 months postpartum.

• Pelvic Symptoms (Pelvic Floor Distress Inventory, PFDI-20)

  Baseline, Gestational Weeks 36-38 and 3 months postpartum.

• Pelvic Floor Function (PERFECT Scheme)

  Baseline and Gestational Weeks 36-38

• Adherence to Intervention

  During pregnancy until 36-38 weeks gestation.

• Acceptability of Intervention

  At 36-38 weeks gestation.

Study Arms (2)

Adapted Physical Activity with or without Pelvic Floor Rehabilitation

EXPERIMENTAL

Participants attend weekly 60-minute sessions of adapted physical activity, from enrollment (≤27 weeks gestation) until 36-38 weeks of pregnancy. Sessions alternate between land and aquatic settings and include mobility, lumbopelvic stabilization, core and multifidus strengthening, and safe aerobic training. If pelvic floor dysfunction is identified at baseline using the Pelvic Floor Distress Inventory (PFDI-20), participants will also receive individualized pelvic floor rehabilitation (up to 9 sessions) focusing on pelvic floor muscle relaxation, strengthening, and coordination.

Behavioral: Adapted Physical Activity; Behavioral: Pelvic Floor Rehabilitation

Standard Care and Educational Flyer

ACTIVE COMPARATOR

Participants receive standard prenatal care as provided by their healthcare providers. In addition, they are given a validated flyer containing international recommendations for safe physical activity during pregnancy. No supervised physiotherapy or structured exercise sessions are provided.

Other: Standard Care (in control arm); Other: Educational Flyer

Interventions

Adapted Physical Activity BEHAVIORAL

Group-based, weekly supervised 60-minute sessions including mobility, stability, strengthening, and aerobic exercises adapted for pregnancy and pelvic girdle pain.

Adapted Physical Activity with or without Pelvic Floor Rehabilitation

Pelvic Floor Rehabilitation BEHAVIORAL

Individual physiotherapy sessions using the PERFECT scheme to assess and retrain pelvic floor muscle function, including education, manual therapy, relaxation, and strengthening

Adapted Physical Activity with or without Pelvic Floor Rehabilitation

Standard Care (in control arm) OTHER

Usual prenatal care provided by obstetricians or midwives according to local practice.

Standard Care and Educational Flyer

Educational Flyer OTHER

Written information with evidence-based international guidelines on physical activity during pregnancy.

Standard Care and Educational Flyer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women aged ≥18 years
• Gestational age ≤27 weeks at enrollment
• Clinically confirmed pelvic girdle pain, defined as:
• Pain localized between the posterior iliac crest and the gluteal fold, particularly around the sacroiliac joints and/or pubic symphysis, Pain intensity ≥3/10 on Visual Analog Scale (VAS), At least 3 positive clinical tests among: Posterior Pelvic Pain Provocation (P4) test, Patrick's FABER, Menell's test, Active Straight Leg Raise (ASLR), and palpation of long dorsal sacroiliac ligament or symphysis pubis
• Ability to understand and provide written informed consent

You may not qualify if:

• Isolated low back pain without pelvic involvement
• Contraindications to exercise during pregnancy (e.g., severe preeclampsia, placenta previa after 26 weeks, risk of preterm labor, ruptured membranes, significant cardiac or pulmonary disease)
• Neurological, rheumatologic, or orthopedic conditions that may interfere with participation
• Insufficient French language proficiency to understand questionnaires and instructions
• Participation in another interventional study that could affect outcomes

Sponsors & Collaborators

• Haute Ecole de Santé Vaud: lead
• La Tour Hospital: collaborator

MeSH Terms

Conditions

Pelvic Girdle Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jeanne BERTUIT, Associate Professor

CONTACT

+41 21 316 81 33; jeanne.bertuit@hesav.ch

Tara REMAN, Assistant Professor

CONTACT

+41 21 556 64 54; tara.reman@hesav.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Neither participants nor investigators are blinded to group assignment due to the nature of the intervention (supervised physical activity and rehabilitation). Outcome assessments are self-reported or clinician-administered and not masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a monocentric, randomized, controlled, open-label exploratory trial with two parallel arms. Forty pregnant women with clinically confirmed pelvic girdle pain will be randomized (1:1) to an intervention group or a control group. The intervention group will participate in weekly sessions of adapted physical activity, specifically designed for pregnant women with pelvic girdle pain, until 36-38 weeks of gestation. If pelvic floor dysfunction is identified, individualized pelvic floor rehabilitation will be added. The control group will receive standard prenatal care and a flyer with international recommendations on safe physical activity during pregnancy. Outcomes will be assessed at baseline (≤27 weeks of gestation), late pregnancy (36-38 weeks), and 3 months postpartum.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 22, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09