María
Alcalá de Henares, Madrid, 28005, Spain
NCT Number: NCT04336150
The purpose of this randomized controlled trial is to compare the effectiveness of different modalities of hypopressive exercise in women with pelvic floor dysfunction. The study evaluates the effects of performing the hypopressive manoeuvre with or without the specific postural programme traditionally used in hypopressive exercise and with or without the addition of voluntary pelvic floor muscle contraction. Transabdominal ultrasound biofeedback is incorporated into the groups performing the hypopressive manoeuvre without the specific postural programme.
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Notify Me18 year–65 year
Female
Interventional
Not applicable
Alcalá de Henares, Madrid, 28005, Spain
This is a four-arm, parallel-group randomized controlled trial conducted in women with pelvic floor dysfunction. Participants are randomly allocated to one of four intervention groups combining different components of hypopressive exercise: the hypopressive manoeuvre performed within the specific postural programme traditionally used in hypopressive exercise, with or without voluntary pelvic floor muscle contraction; or the hypopressive manoeuvre performed without the specific postural programme, with or without voluntary pelvic floor muscle contraction.
All interventions are delivered individually under physiotherapist supervision and include an educational component addressing the anatomy and physiology of the abdominopelvic cavity and pelvic floor, together with hygienic and behavioural recommendations for the prevention and management of pelvic floor dysfunction.
The hypopressive manoeuvre consists of expiration followed by expiratory apnoea and active rib-cage expansion without inhalation, accompanied by inward and cranial displacement of the abdominal wall. In the groups using the specific hypopressive postural programme, the manoeuvre is incorporated into a sequence of postures performed in different body positions according to the principles of Hypopressive Abdominal Gymnastics.
In the groups performing the hypopressive manoeuvre without the specific postural programme, real-time transabdominal ultrasound imaging is used as visual biofeedback to facilitate motor learning and contraction of the transversus abdominis muscle during performance of the manoeuvre.
Interventions are performed twice weekly in individually supervised 45-minute sessions. Participants following the specific hypopressive postural programme receive 16 sessions over 8 weeks, whereas participants performing the hypopressive manoeuvre without the specific postural programme receive 12 sessions over 6 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See information included in arm/group descriptions.
See information included in arm/group descriptions.
See information included in arm/group descriptions.
See information included in arm/group descriptions.
Time frame: 4 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 month and 6 months after the intervention.
It will be assessed by the PFIQ-7 Spanish version. The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).
Time frame: 4 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months and 6 months after the intervention.
It will be assessed by PFDI-20 that is both a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse quality of life. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms.
Time frame: 4 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months and 6 months after the intervention.
It will be measured by dynamometry (measured in GRAMS).
Time frame: 4 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months and 6 months after the intervention.
It will be measured by dinamometry (measured in GRAMS)
University of Alcala
Other
Effects of Voluntary Pelvic Floor Muscle Contraction During Different Modalities of Hypopressive Exercise in Women With Pelvic Floor Dysfunction: A Randomized Controlled Trial
Acronym: HIPOSPFD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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