Adapted Physical Activity Based On Trunk Stabilization And Pelvic Floor Education For Female Pelvic Floor Disorders

Effect Of An Intervention Combining Adapted Physical Activity Based On Trunk Stabilization And Pelvic Floor Education For Female Pelvic Floor Disorders

Pelvic floor disorders affect a substantial proportion of women worldwide and represent a significant public health concern due to their impact on physical function, quality of life, and psychosocial well-being. Growing interest has emerged in physical activity programs for pelvic floor disorders as a noninvasive and accessible intervention strategy.

This study aims to evaluate the effect of an intervention combining a weekly Adapted Physical Activity (APA) session focused on trunk stabilization and a monthly pelvic floor education session over a three-month period to improve self-reported pelvic floor symptoms. The secondary objectives are to investigate the effects of this intervention on quality of life, pelvic floor knowledge, stigma, care-seeking behavior, and physical activity behavior.

Participants will be randomly assigned to one of two groups for 3 months: (1) intervention APA + education or (2) waitlist. Participants in the waitlist group will receive the intervention three months after the program's launch.

This study could help provide additional data to improve education of the pelvic floor and care seeking, as well as to better understand the effect of physical activity for pelvic floor disorders.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Floor Disorder
• Intervention / Treatment: Behavioral: Adapted Physical Activity and education

Detailed Description

This study will include women who reported having a pelvic floor disorder. The study will be a randomized controlled trial with three measurement time points, before and after the intervention (immediate post-test and delayed post-test at 3 months), and two groups. One group will receive Adapted Physical Activity (APA) + education intervention, and the control group will be placed on a waiting list for 3 months. Participants in the control group may then follow the program if they wish.

We hypothesize that APA program based on trunk stabilization combined with an educational intervention improves self-reported symptoms of pelvic floor disorders, knowledge, and care-seeking behavior (including physical activity) compared to a group that receives no intervention. We expect these effects to appear immediately after the intervention (immediate post-test) and to persist over time (delayed post-test at 3 months).

APA refers both to tailored exercise or sports interventions designed to promote health among people with chronic diseases, health conditions, or disabilities and to a scientific discipline that designs and studies interventions for health and educational purposes. APA provides a framework for implementing the principles of trunk stabilization in the context of pelvic floor disorders, notably through learning diaphragmatic breathing and the co-activation of the pelvic floor and the transversus abdominis, specific training to strengthen the core muscles, and incorporating dynamic exercises with light to moderate impact (jumps, side steps, etc.).

Adapted physical activity sessions based on the trunk stabilization principle will last 60 minutes and will include 15-minute warm-up (body and joint mobilizations from head to toe, and breathing exercise) followed by 30-minute main continuous session (trunk stabilization and strengthening exercises), and 15-minute cooldown for stretching and mobility exercises. The programme will be organized in three phases, to be implemented progressively: (1) learning the diaphragmatic breathing pattern, the co-activation of the pelvic floor and the transversus abdominis muscles in standing, sitting, and lying positions; (2) specifically working the engagement of the transversus abdominis muscles in static, dynamic, and balance exercises while strengthening the core muscles; (3) integrating dynamic exercises with light to moderate impact (jumping, side steps, etc.). Exercise instructions will include posture, pelvic floor engagement, and respiratory instructions on effort.

The educational sessions will last between 60 to 90 minutes. The first session will focus on the prevalence and common beliefs surrounding the pelvic floor, providing a brief introduction to common risk factors. The functioning (anatomy, function, and biomechanics) of the pelvic floor will then be presented using educational anatomical videos. In the second session, lifestyle-related risk factors and preventive measures will be discussed through a group workshop (e.g. urinary and defecatory physiologies, the impact of sport, posture, overweight and obesity, and hygiene and dietary recommendations for constipation). Participants will be invited to consider how to plan their physical activity in anticipation of the end of the program and any obstacles they may need to overcome. The final session will cover the care pathways available for pelvic floor disorders; participants will then be invited to consider how to plan for a potential future appointment with a healthcare professional and any barriers they may need to overcome.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Anne Jean; Phone Number: +33 6 43 03 62 44; Email: ma.jean@unistra.fr

Study Locations

• France
  • Alsace
    • Mulhouse, Alsace, France, 68 100
      • Université de Strasbourg
      • Contact: Marie-Anne Jean; Phone Number: +33669246464; Email: ma.jean@unistra.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women over 18 years old
• At least one symptom associated with a pelvic floor disorder (urinary or faecal incontinence, a feeling of heaviness or bulging in the genital area, difficulty passing stools) which causes bother (ranging from mild to severe)
• Not already undergoing pelvic floor rehabilitation with a professional (physiotherapist or midwife)
• No major mobility limitations such as being unable to get up from a supine to standing position unassisted
• Proficient in reading, writing and speaking French
• Not pregnant
• BMI below 40
• Regardless of hormonal status (natural cycle, contraceptive pill, menopause)

Exclusion Criteria:

• Scheduled surgery during the study
• Postpartum (less than 3 months)
• Pelvic surgery in the past 3 months
• Current urinary tract infection or haematuria
• Current pelvic cancer or radiation, Interstitial cystitis
• Congenital defect leading to pelvic floor disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention APA + education; This group will participate in a program combining a weekly session of adapted physical activity focused on trunk stabilization and a monthly session on pelvic floor education, over a three-month period.	Behavioral: Adapted Physical Activity and education; Intervention combining a weekly session of adapted physical activity focused on trunk stabilization and a monthly pelvic floor education session, over a three-month period; Other Names: Adapted Physical Activity; Pelvic floor education
No Intervention: Waiting list; The waiting list will not receive the intervention for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported pelvic floor symptoms: Pelvic Floor Distress Inventory short-form questionnaire (PFDI-20)	The PFDI-20 has a total of 20 questions and 3 scales: Urinary Distress Inventory (UDI-6, questions 1 to 6), Pelvic Organ Prolapse Distress Inventory (POPDI-6, questions 7 to 14), and the Colorectal-Anal Distress Inventory (CRADI-8, questions 15 to 20). Each of the 3 scales of the PFDI-20 has a score range from 0 (least distress) to 100 (greatest distress) and is calculated based on the mean score of the questions (values ranging from 0 to 4), multiplied by 25. The total PFDI-20 score is obtained by summing the scores for each scale (ranging from 0 to 300).	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Floor impact on Quality-of-life short form questionnaire (PFIQ-7)	This questionnaire consists of a table with 7 questions in lines and each of 3 scales in columns for the Urinary Impact Questionnaire (UIQ), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ), and the Colorectal-Anal Impact Questionnaire (CRAIQ). Each of the 3 scales is scored from 0 (no impact) to 100 (greatest adverse impact) and is calculated based on the mean score of the questions (a value between 0 and 3) and then multiplied by 100/3 to derive the scale score (ranging from 0 to 100). The total PFIQ-7 score is obtained by summing the scores for each scale (ranging from 0 to 300).	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Knoledge of the pelvic floor: Antwerp Pelvic Floor Knowledge Questionnaire (APFK-Q)	Knowledge of the pelvic floor will be assessed with the APFK-Q. This questionnaire contains 33 items, and 31 items assess women's knowledge of the structure and function of the pelvic floor, urinary and defecatory physiology, the main pelvic floor disorders, risk factors, and management of pelvic floor disorders. Two items were dedicated to the perception of the level of self-knowledge of the participant concerning the pelvic floor (item 1) and care pathway (item 33). No scoring method is provided for this questionnaire; therefore, a percentage of total correct answers can be calculated across the knowledge assessment items.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Stigma related to pelvic floor disorders: Stigma Scale for Chronic Illnesses 8-Item Version (SSCI-8)	Enacted and internalized stigma related to pelvic floor disorders will be assessed with the SSCI-8 adapted for pelvic floor disorders. Each of the 8 items is rated from 1 (Never) to 5 (Always). The total score ranges from 8 to 40, calculated by summing all the items. This tool has already been used in a population with pelvic floor disorders.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Social support: Sarason's Social Support Questionnaire (SSQ6)	This questionnaire is a 12-item measure comprising two questions per item that assess perceived social support availability and satisfaction. For each of the six situations, respondents indicate the people they could count on (up to a maximum of nine people) and rate their satisfaction with the available support on a 6-point scale, from 1 (very dissatisfied) to 6 (very satisfied). Two separate total scores are calculated: an availability score (N), corresponding to the total number of people listed across the six situations and ranging from 0 to 54, and a satisfaction score and a satisfaction score (S), obtained by summing the six satisfaction ratings and ranging from 6 to 36. Higher N scores indicate greater perceived availability of social support, while higher S scores indicate greater satisfaction with the available support.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Physical activity behavior: International Physical Activity Questionnaire short-form (IPAQ)	For each type of physical activity, the MET-minutes per week are calculated by multiplying the number of minutes spent on the activity per day by the number of days per week on which the activity is performed and by the corresponding MET value. An average MET score has been established for each type of activity. Total physical activity is then calculated by summing the MET-minutes per week for walking, moderate-intensity physical activity, and vigorous-intensity physical activity.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Care-seeking behavior	Care seeking is assessed using three questions. (1) related to consultation, (2) related to initiation of pelvic floor rehabilitation with a professional (physiotherapist or midwife), and (3) related to discontinuation of the planned pelvic floor rehabilitation. The results will be presented in four categories: (1) did not seek care, (2) consulted a healthcare professional, (3) began supervised pelvic floor rehabilitation (physiotherapist or midwife), and (4) discontinued pelvic floor rehabilitation prematurely. The outcome analyzed will be a binary measure of engagement in the process of care seeking. Individuals who sought care will be counted in care-seeking behavior and compared with those who did not initiate the process.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation for physical activity in a health context	Physical Activity in a Health Context [Echelle de Motivation envers l'Activité Physique dans un context de Santé] is a scale based on self-determination theory and assesses six forms of motivation, each with its own score: intrinsic (item 1, 6,11), integrated (item 7, 10, 13), identified (item 4, 12, 16), introjected (item 3, 14, 18), external regulation (item 9, 15, 17), and amotivation (2, 5, 8). The scores are calculated by averaging the three scores associated with each form of motivation.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Motivational and volitional stage assessment (care-seeking and physical activity behavior)	These variables are a part of the Health Action Process Approach model. The motivational and volitional stage assessment related to physical activity behavior and related to care-seeking behavior evaluates the participant's intention and action related to the behavior and corresponds to a scale ranging from 0 (no action and no intention) to 5 (action continuing) for each behavior.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Outcome expectancies (care-seeking and physical activity behavior)	These variables are a part of the Health Action Process Approach model. Outcome expectancies (positive and negative separately) related to physical activity behavior and related to care-seeking behavior consist of 5 positive and 5 negative statements for each scale (care seeking and physical activity) regarding pelvic floor disorders. The participant rates their level of agreement with each statement on a scale from 1 (strongly disagree) to 7 (strongly agree). The final score is the average of the scores for positive expectations and negative expectations separately.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Action self-efficacy related to care-seeking	This variable is a part of the Health Action Process Approach model. Action self-efficacy related to care-seeking will be measured using 2 statements where the participant rates their level of agreement on a scale from 1 (strongly disagree) to 7 (strongly agree). The final score is the average of the 2 statement scores. A high score indicates a high level of action self-efficacy.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Maintenance self-efficacy related to physical activity behavior	This variable is a part of the Health Action Process Approach model. Maintenance self-efficacy related to physical activity behavior will be measured using 2 statements where the participant rates their level of agreement on a scale from 1 (strongly disagree) to 7 (strongly agree). The final score is the average of the 2 statement scores. A high score indicates a high level of maintenance self-efficacy.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Recovery self-efficacy related to physical activity behavior	This variable is a part of the Health Action Process Approach model. Recovery self-efficacy related to physical activity behavior will be measured using 3 statements where the participant rates their level of agreement on a scale from 0 (strongly disagree) to 7 (strongly agree). The final score is the average of the 3 statement scores. A high score indicates a high level of recovery self-efficacy.	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Action control related to physical activity behavior	This variable is a part of the Health Action Process Approach model. Action control related to physical activity behavior will be measured using 3 statements where the participant rates their level of agreement on a scale from 0 (strongly disagree) to 7 (strongly agree).	Before the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)
Pelvic Floor Muscle Control Score	About ten volunteer participants will be able to receive a perineal probe. They will be free to use it or not. Participants will be able to submit data on the duration of use and their pelvic floor muscle control score, which is based on a series of different types of contractions: endurance, speed, and repetition.	At the start of the intervention (T0), at the end of the intervention (T1, 3 months) and at follow-up (T2, 3 months post-intervention)

Collaborators and Investigators

• Sponsor: Université de Strasbourg
• Investigators: Study Director: Maria Popa-Roch, Université de Strasbourg; Study Director: Géraldine Escriva-Boulley, University of Nimes

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: women's health; exercise intervention; behaviour change; care seeking
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Pelvic Floor Disorders; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: Unistra/CER/2025-91; 202407417 (Other Grant/Funding Number: Agence Régionale de Santé Grand-Est); 25E0015642825-DOC-031 (Other Grant/Funding Number: Région Grand Est)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No