Clinical trial NCT05722821: Effects of Hypopressive Abdominal Gymnastics in Urinary Incontinence
Official title: Effects of Hypopressive Abdominal Gymnastics (GAH) in Spanish Postmenopausal Women With Urinary Incontinence: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Older Adults
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 112
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The increase in the age of the population is a problem that affects both Spain and the rest of the world. Life expectancy increases, and this will influence the quality of life that older people will have. The quality of life is related to the health of the population. Women live longer than men and have diseases such as urinary incontinence that are more frequent in them. This is related to childbirth, increasing age, and menopause due to the hormonal level. Therefore, there are a series of problems related to both physical and mental health associated both with increasing age and with the situation of hormonal change that occurs after the onset of menopause. All of this will influence deficient pelvic musculature, sexual function, sleep quality, and depression/anxiety. Conservative treatment using hypopressive abdominal exercises has been shown to be beneficial at the level of health in female populations with urinary incontinence. The challenge lies in designing exercise programs that, in addition to achieving these benefits, are attractive with acceptance and adherence. The objective of this doctoral thesis is to study the effects of hypopressive abdominal exercises for 12 weeks on quality of life related to urinary incontinence in women, sleep quality, anxiety and depression, and female sexual function in women. Spanish postmenopausal women.

Detailed description: Society is facing a longer life expectancy due to improvements in medicine, which leads to an increase in the aging population. According to the National Institute of Statistics (INE), the population over 65 years of age has been increasing from 2001 to 2020, assuming a growth of 14.6% in Europe and 13.6% in Spain. Demographic indicators indicate a greater increase in life expectancy in women (from 82.7-85.1 years) than in men (75.9-79.6 years).

Currently, women present more specific health problems than men due to their physiological conditions, such as the menopausal transition. At the vasomotor level, hot flashes or hot flashes form the most distinctive element of this stage at the sexual level, such as the lack of lubrication, discomfort or pain, and altered function; on a psychological level, anxiety and depression, which is a syndrome linked to disorders such as sadness and its impact on menopause, is quite significant; and the affectation of sleep that are one of the main complaints of women at this stage. All these symptoms affect the quality of life of women both physically and mentally.

With aging and the incidence of menopause, a series of changes in women's health take place, constituting a natural and inevitable process; which can cause unwanted events, such as urinary incontinence. UI is defined as the involuntary loss of urine, within urinary incontinence the most prevalent is stress urinary incontinence (SUI) in 10-30% in most studies, and compared to men 75% of women are more affected than men. This condition can cause disorders in the quality of life, and among the main risk factors are increasing age, parity, family history of prolapse, obesity, lifting heavy objects and constipation also influences. Women with prolapses may present with vaginal, bladder, bowel, back, abdominal, and sexual symptoms. Women frequently suffer from UI due to atrophic changes in the urogenital tract. Therefore, a conservative treatment where the evaluation of the pelvic floor strength and the functional use of pelvic floor muscle training are previously carried out is recommended to achieve health benefits and therefore quality of life.

Recent studies have shown that women with pelvic floor dysfunctions who perform pelvic floor muscle training through hypopressive abdominal exercises improve the pelvic muscles and quality of life of postmenopausal women with UI and prolapses. The hypopressive abdominal exercises (AHT) technique can be classified as a breathing exercise. It was developed by Dr. Marcel Caufriez, a physical therapist in 1980. This inventor theorized that the decrease in abdominal pressure obtained with AHT may produce reflex activation of the abdominal wall and pelvic floor muscles, thus reducing UI and prolapses. The AHT, in summary, involves diaphragmatic breathing, total air breathing, and gradual contraction of the transverse abdominis and intercostal muscles with rise in the diaphragm and apnea. This conservative treatment technique is adaptable to the mind (since you have to concentrate on breathing) and body integration exercise that can be worked on anywhere and anytime, without the need for special equipment.

The directors of this doctoral thesis have experience in this field, with several works published in journals located in the first tercile and quartile of their categories according to the JCR index.

Eligibility criteria: Inclusion Criteria:

* Women with urinary incontinence with cessation of menstrual activity for 12 months or more and who are able to understand the instructions and exercise protocols of this project.

Exclusion Criteria:

* Contraindications for physical tests, cancer or serious illness, musculoskeletal and neurological diseases (Parkinson's disease, multiple sclerosis, diabetic neuropathy, cerebrovascular accident, etc.).
* Taking drugs that affect the central nervous system or antidepressants, or lack of willingness to participate in the study.
* People who have previously carried out pelvic floor reeducation programs.

Primary outcomes:
measure: International Consulation on Incontinence Short Quality of Life Questionnaire
timeFrame: Up to twelve weeks
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: Up to twelve weeks
measure: Pelvic organ prolapse/urinary incontinence sexual function questionnaire-12
timeFrame: Up to twelve weeks
measure: Prolapse quality of life questionnaire
timeFrame: Up to twelve weeks
measure: Handgrip Strength
timeFrame: Up to twelve weeks
measure: TUG test (Timed Up and Go test)
timeFrame: Up to twelve weeks
measure: Chair sit and reach test.
timeFrame: Up to twelve weeks
measure: Back scratch test.
timeFrame: Up to twelve weeks
Secondary outcomes:
measure: BMI (Body Mass Index)
timeFrame: Up to twelve weeks
measure: Waist circumference.
timeFrame: Up to twelve weeks
measure: Hip circumference
timeFrame: Up to twelve weeks
measure: Waist-to-hip ratio.
timeFrame: Up to twelve weeks
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Center for the Elderly "Gallur"
Study officials:
References: