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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversité de Strasbourg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Scheduled surgery during the study

Postpartum (less than 3 months)

Pelvic surgery in the past 3 months

Current urinary tract infection or haematuria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adapted Physical Activity and education

    Behavioral

    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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Intervention APA + educationExperimental treatment 1 intervention
Group B: Waiting listNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
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 outcomes

1

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).

Time frame
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)
2

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.

Time frame
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)
3

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.

Time frame
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)
4

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.

Time frame
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 outcomes

1

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.

Time frame
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)
2

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.

Time frame
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)
3

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.

Time frame
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)
4

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.

Time frame
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)

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