Effect of Hypopressive Gymnastics Associated or Not With... | NCT04339010

Status Module

Oversight Module

Description Module

Detailed Description

This was a single-blind randomized controlled trial comparing the effect of AHT versus AHT associated with PFM contraction in incontinent women. The study was approved by the Research Ethics of Santa Catarina State University (number 3.712.850) and each participating provided the written informed consent signed. Women were randomly assigned to either an AHT group or the AHT associated with PFM contraction (AHT + PFMC) group. The first group underwent a hypopressive exercise program that does not stimulate the PFM contraction, while the other group receives the AHT associated with PFM contraction stimulated by the physiotherapist during the sessions. Following eligibility screening by the research, the women were allocated in an of the two groups. Group allocation results were concealed by opaque, sealed envelopes with serial numbers, and the participants were assigned at the second visit by opening envelops in a sequential manner, after their eligibility was assessed at the first visit. Study investigators were blinded to treatment allocation. Participants underwent a five weeks intervention after the first evaluation, and the final evaluation occurred one week later on a date according to the participant availability.

The first three sessions were designated to learn how to perform the exercises and your variations correctly were part of the five weeks intervention. The intervention was performed in a forty-minute training session in two-week meetings during five consecutive weeks. All women included in this trial, independently of the group, received standardized lifestyle advice including, when appropriate, instructions about weight loss, constipation, hydration and the avoidance of heavy lifting. It is very important to emphasize that the time dedicated to performing the daily exercises was similar. The therapist applying the protocol was appropriately trained especially for the trial and it was not the same professional who conducted the evaluations.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypopressive	Experimental	st session: the meetings were provided by a physiotherapist, who also discussed the location and function of the pelvic organs, PFM, and the transversus abdominis (TrA) muscles. The participants learned how to activate TrA muscles. The training was performed during full expiration, the physiotherapist check and coordinate the group to maintain the Tra contraction. The women were also trained to inhale through the nose and exhale through the mouth maintaining an apical breathing pattern. nd session: The contractions were executed during six different positions the ones which they will keep following through the whole treatment. rd session: The patients were exposed to all the six positions (supplementary material) and their three variations (positions 1, 3, 5 and 6 ). Every meeting obeyed the same schedule through the five weeks of treatment and was accompanied by two physiotherapists.	Other: Hypopressive exercise
Hypopressive + PFMC	Active Comparator	This group receives the same protocol than the Hypopressive group, but with a verbal command to realize the PFM contraction during the activation of the deep abdominal muscle.	Other: Hypopressive exercise Other: Pelvic floor muscle contraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypopressive exercise	Other	The hypopressive exercise is performed mainly via transversus abdominis (Tra) activation. The exercise relaxes the diaphragm, decreases intra-abdominal pressure and may activate the abdominal and PFM simultaneously.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary incontinence symptoms	Will be assessed by evaluating the ICIQ-SF questionnaire that assesses the frequency, severity, and impact on the quality of life of urinary incontinence (UI). The three scored items of the ICIQ-UI SF are: [1] ''How often do you leak urine?'' (0 ''Never" 1 ''About once a week or less often,'' 2 ''Two or three times a week,'' 3 ''About once a day,'' 4 ''Several times a day,'' 5 ''All the time''), [2] ''How much urine do you usually leak?'' (0 ''None,'' 2 ''A small amount,'' 4 ''A moderate amount,'' and 6 ''A large amount''), and [3] ''Overall, how much does leaking urine interfere with your everyday life?'' (Visual analog scale ranging from 0 ''Not at all'' to 10 ''A great deal''). The answers result in a sum, with a minimum score of 0, and a maximum score of 21. Preliminary cut-off scores were set to 0 as ''continent status'' and 1 or more as ''incontinence status".	Pre intervention and 1 week post intervention

Secondary Outcomes

Measure	Description	Time Frame
Maximal voluntary contraction	Peritron 9300® manometer will be used to assess the maximum voluntary contraction (MVC). An MVC of PFM will be asked to the participant and the peak value was recorded, this process was repeated 3 times. The mean value of these three pressure peaks corresponded to MVC of the PFM.	Pre intervention and 1 week post intervention

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Center for Health and Sport Sciences		Florianópolis	Santa Catarina	88080-350	Brazil

ID	Term
D014549	Urinary Incontinence
D059952	Pelvic Floor Disorders

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D059411	Lower Urinary Tract Symptoms
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011248	Pregnancy Complications