Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT07186504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adapted Physical Activity and Pelvic Floor Function for Pelvic Girdle Pain During Pregnancy
Sponsor:
Haute Ecole de Santé Vaud
Organization:
Study Overview
Official Title:
Impact of Adapted Physical Activity Combined With Pelvic Floor Functionality on Pelvic Girdle Pain During Pregnancy: A Randomized Controlled Exploratory Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Background and Rationale
Pregnancy induces substantial morphological, hormonal, and biomechanical changes that increase the risk of musculoskeletal pain, particularly pelvic girdle pain (PGP). Up to 63% of pregnant women experience PGP, which may significantly affect mobility, quality of life, and psychological well-being. Although international guidelines, including those of the American College of Obstetricians and Gynecologists (ACOG), recommend physical activity during pregnancy, few interventions specifically target PGP, and the role of pelvic floor function has been largely overlooked.
The pelvic floor contributes to lumbopelvic stability through myofascial connections and motor control. Dysfunction of the pelvic floor muscles is frequently observed in women with PGP, with symptoms such as hypertonicity, poor endurance, and ineffective contractions. Evidence suggests an association between pelvic floor dysfunction and pelvic pain, but no trial to date has combined adapted physical activity with targeted pelvic floor rehabilitation in pregnant women with PGP.
Objectives
The primary objective of this exploratory randomized controlled trial is to evaluate the effect of a combined intervention (adapted physical activity with optional individualized pelvic floor rehabilitation) on pain intensity and functional impact of PGP during pregnancy.
Secondary objectives include:
* To assess the effect of the intervention on pelvic symptoms and pelvic floor functionality.
* To explore the relationship between pelvic floor dysfunction and the course of PGP.
* To evaluate adherence and acceptability of the intervention program.
Study Design
This is a monocentric, randomized, controlled, open-label exploratory trial conducted at Hospital La Tour in Geneva, Switzerland. Forty pregnant women with clinically confirmed PGP will be randomly assigned (1:1) to an intervention group or a control group. Randomization will be stratified by gestational age and baseline pain intensity.
Intervention group: Weekly adapted physical activity sessions in group format (minimum 9 sessions, 60 minutes each), from enrollment until 36-38 weeks of gestation. Sessions alternate between land and pool settings and include lumbopelvic stabilization, core and multifidus strengthening, mobility, and cardiorespiratory training. Women identified with pelvic floor dysfunction at baseline (via the Pelvic Floor Distress Inventory, PFDI-20) will also be offered up to 9 sessions of individualized pelvic floor rehabilitation.
Control group: Standard prenatal follow-up and a flyer with evidence-based recommendations on safe physical activity during pregnancy. No supervised sessions are provided.
Study Population
Eligible participants are pregnant women ≤27 weeks of gestation with clinically confirmed PGP of moderate to severe intensity (VAS ≥3/10). Diagnosis requires typical pain localization and at least 3 positive clinical tests (e.g., P4 test, Patrick FABER, Menell, ASLR). Exclusion criteria include isolated low back pain without pelvic involvement or any medical contraindication to exercise during pregnancy.
Outcomes
1. Primary outcomes:
* Pain intensity measured by the Visual Analog Scale (VAS, 0-10 cm).
* Functional impact of PGP measured by the Pelvic Girdle Questionnaire (PGQ, 25 items, score 0-100).
2. Secondary outcomes:
* Physical activity (Pregnancy Physical Activity Questionnaire, PPAQ).
* Pelvic symptoms (Pelvic Floor Distress Inventory, PFDI-20).
* Pelvic floor function (PERFECT scheme by digital palpation).
* Adherence to intervention (≥75% of sessions attended).
* Acceptability (post-intervention questionnaire with Likert scales).
Assessments occur at baseline (≤27 weeks), late pregnancy (36-38 weeks), and 3 months postpartum.
Sample Size and Statistical Considerations
Sample size (n=40, 20 per group) was determined based on detecting a clinically meaningful reduction in VAS pain scores, with α=0.05, 95% power, and an expected large effect size (d=0.8). Data will be analyzed on an intention-to-treat basis using descriptive statistics, parametric or non-parametric tests as appropriate, and mixed linear models including relevant covariates (e.g., parity, baseline scores).
Duration and Timeline
The project will last 27 months in total. Enrollment will begin in September 2025 and end in December 2026. The last postpartum follow-up will occur in March 2027, and the study will close in October 2027. Individual participation lasts approximately 6-8 months.
Ethical Considerations
The study is categorized as minimal risk (Category A under Swiss ClinO). All interventions are non-invasive, adapted to pregnancy, and consistent with international standards for prenatal physiotherapy. Approval will be obtained from the Commission Cantonale d'Éthique de la Recherche sur l'être humain (CCER), affiliated with swissethics. Participation is voluntary, and women may withdraw at any time without affecting their standard care. Data will be managed securely in REDCap with strict confidentiality measures.
Significance
This trial will generate new evidence on a comprehensive approach integrating adapted physical activity with pelvic floor rehabilitation for managing pelvic girdle pain in pregnancy. If effective, it could inform physiotherapy practice and contribute to international guidelines, ultimately improving maternal health and quality of life.
Pregnancy induces substantial morphological, hormonal, and biomechanical changes that increase the risk of musculoskeletal pain, particularly pelvic girdle pain (PGP). Up to 63% of pregnant women experience PGP, which may significantly affect mobility, quality of life, and psychological well-being. Although international guidelines, including those of the American College of Obstetricians and Gynecologists (ACOG), recommend physical activity during pregnancy, few interventions specifically target PGP, and the role of pelvic floor function has been largely overlooked.
The pelvic floor contributes to lumbopelvic stability through myofascial connections and motor control. Dysfunction of the pelvic floor muscles is frequently observed in women with PGP, with symptoms such as hypertonicity, poor endurance, and ineffective contractions. Evidence suggests an association between pelvic floor dysfunction and pelvic pain, but no trial to date has combined adapted physical activity with targeted pelvic floor rehabilitation in pregnant women with PGP.
Objectives
The primary objective of this exploratory randomized controlled trial is to evaluate the effect of a combined intervention (adapted physical activity with optional individualized pelvic floor rehabilitation) on pain intensity and functional impact of PGP during pregnancy.
Secondary objectives include:
* To assess the effect of the intervention on pelvic symptoms and pelvic floor functionality.
* To explore the relationship between pelvic floor dysfunction and the course of PGP.
* To evaluate adherence and acceptability of the intervention program.
Study Design
This is a monocentric, randomized, controlled, open-label exploratory trial conducted at Hospital La Tour in Geneva, Switzerland. Forty pregnant women with clinically confirmed PGP will be randomly assigned (1:1) to an intervention group or a control group. Randomization will be stratified by gestational age and baseline pain intensity.
Intervention group: Weekly adapted physical activity sessions in group format (minimum 9 sessions, 60 minutes each), from enrollment until 36-38 weeks of gestation. Sessions alternate between land and pool settings and include lumbopelvic stabilization, core and multifidus strengthening, mobility, and cardiorespiratory training. Women identified with pelvic floor dysfunction at baseline (via the Pelvic Floor Distress Inventory, PFDI-20) will also be offered up to 9 sessions of individualized pelvic floor rehabilitation.
Control group: Standard prenatal follow-up and a flyer with evidence-based recommendations on safe physical activity during pregnancy. No supervised sessions are provided.
Study Population
Eligible participants are pregnant women ≤27 weeks of gestation with clinically confirmed PGP of moderate to severe intensity (VAS ≥3/10). Diagnosis requires typical pain localization and at least 3 positive clinical tests (e.g., P4 test, Patrick FABER, Menell, ASLR). Exclusion criteria include isolated low back pain without pelvic involvement or any medical contraindication to exercise during pregnancy.
Outcomes
1. Primary outcomes:
* Pain intensity measured by the Visual Analog Scale (VAS, 0-10 cm).
* Functional impact of PGP measured by the Pelvic Girdle Questionnaire (PGQ, 25 items, score 0-100).
2. Secondary outcomes:
* Physical activity (Pregnancy Physical Activity Questionnaire, PPAQ).
* Pelvic symptoms (Pelvic Floor Distress Inventory, PFDI-20).
* Pelvic floor function (PERFECT scheme by digital palpation).
* Adherence to intervention (≥75% of sessions attended).
* Acceptability (post-intervention questionnaire with Likert scales).
Assessments occur at baseline (≤27 weeks), late pregnancy (36-38 weeks), and 3 months postpartum.
Sample Size and Statistical Considerations
Sample size (n=40, 20 per group) was determined based on detecting a clinically meaningful reduction in VAS pain scores, with α=0.05, 95% power, and an expected large effect size (d=0.8). Data will be analyzed on an intention-to-treat basis using descriptive statistics, parametric or non-parametric tests as appropriate, and mixed linear models including relevant covariates (e.g., parity, baseline scores).
Duration and Timeline
The project will last 27 months in total. Enrollment will begin in September 2025 and end in December 2026. The last postpartum follow-up will occur in March 2027, and the study will close in October 2027. Individual participation lasts approximately 6-8 months.
Ethical Considerations
The study is categorized as minimal risk (Category A under Swiss ClinO). All interventions are non-invasive, adapted to pregnancy, and consistent with international standards for prenatal physiotherapy. Approval will be obtained from the Commission Cantonale d'Éthique de la Recherche sur l'être humain (CCER), affiliated with swissethics. Participation is voluntary, and women may withdraw at any time without affecting their standard care. Data will be managed securely in REDCap with strict confidentiality measures.
Significance
This trial will generate new evidence on a comprehensive approach integrating adapted physical activity with pelvic floor rehabilitation for managing pelvic girdle pain in pregnancy. If effective, it could inform physiotherapy practice and contribute to international guidelines, ultimately improving maternal health and quality of life.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: