MenopauseNCT05722821
Effects of Hypopressive Abdominal Gymnastics in Urinary Incontinence
A study testing Hypopressive intervention in people with Menopause and Older Adults, run by University of Jaén at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Menopause, Older Adults
- What is being tested?
- Hypopressive intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2023to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hypopressive Abdominal Gymnastics (GAH) in Spanish Postmenopausal Women With Urinary Incontinence: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Menopause, Older Adults
- Being tested
- Hypopressive intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypopressive interventionOther
Hypopressive abdominal gymnastics is based on a basic level hypopressive exercise program that will be:
- A duration of 12 weeks with a frequency of 2 sessions a week and lasting 45 minutes each. Hypopressive abdominal exercises will be performed individually adapted to the capacity of the participant.
- There will be an initial anatomical training of the muscles involved in carrying out the exercise and practice in the respiratory technique for a duration of 15 minutes. Afterwards, hypopressive exercises will begin for 20-30 minutes, changing positions if possible.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | An experimental group (GE): that after an initial evaluation will be subjected to a hypopressive abdominal gymnastics program, for 12 weeks with 2 weekly sessions (Tuesday and Thursday, controlling adherence to the sessions through attendance), with a duration of 45 min per session. Once the intervention is finished, you will be subjected to a final evaluation to see if there is a difference or not with the results obtained at the beginning. Receives: Other: Hypopressive intervention |
| Control group | No intervention | A control group (CG): that will not be subjected to treatment, which will be evaluated in the pre and post phase of the study, and a follow-up by telephone contact of adherence to physical activity. The participants assigned to this group will receive general advice on the positive effects of the regular practice of physical activity aimed at preventing urinary incontinence, and they will be given the guide of recommendations for the promotion of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consulation on Incontinence Short Quality of Life Questionnaire
Is a brief questionnaire aimed at measuring the perception of UI symptoms and the patient's quality of life. The scores of the questions 1+2+3 are added.
Any score greater than zero is considered a diagnosis of UI.
Measured: Up to twelve weeks
PSQI (Pittsburgh Sleep Quality Index)
A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.
Measured: Up to twelve weeks
Pelvic organ prolapse/urinary incontinence sexual function questionnaire-12
It is an instrument with adequate psychometric characteristics to assess sexual function in women with pelvic floor problems in Spain. The score is made by adding the scores of each item, (from 0=always to 4=never), inverting this score for items 1, 2, 3, and 4.
Measured: Up to twelve weeks
Prolapse quality of life questionnaire
The P-QoL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health (1 item), prolapse impact (1 item), role limitations (2 items), physical limitations (2 items), social limitations (3 items), personal relationships (2 items), emotions (3 items), sleep/energy (2 items) and severity measures (4 items). Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life. Additionally, there are 18 questions regarding urinary, bowel, and prolapse/vaginal symptoms, which do not have an assigned score. Response options are on a Likert scale with ranges between 1 and 4, except for the first question, that ranges between 1 and 5. Symptoms questions and personal relationships domains offer the option Not applicable.
Measured: Up to twelve weeks
Handgrip Strength
Dynamometer will be employed to assess hand grip strength.
Measured: Up to twelve weeks
TUG test (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function.
Measured: Up to twelve weeks
Chair sit and reach test.
To test low back and hamstring flexibility.
Measured: Up to twelve weeks
Back scratch test.
To measure general shoulder range of motion.
Measured: Up to twelve weeks
Secondary outcomes (4)
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Measured: Up to twelve weeks
Waist circumference.
Is used to assess central fat distribution and degree of abdominal obesity.
Measured: Up to twelve weeks
Hip circumference
It is the greatest circumference of hip.
Measured: Up to twelve weeks
Waist-to-hip ratio.
Is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start13 Mar 2023
- Primary completion2 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722821
- Sponsor's protocol ID
- - University of Jaén.
- Status last verified
- May 2025
- First submitted
- 1 Feb 2023
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypopressive Abdominal Gymnastics (GAH) in Spanish Postmenopausal Women With Urinary Incontinence: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05722821
- Acronym / sponsor ID
- - University of Jaén.
- Conditions
- Menopause, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Hypopressive interventionAn experimental group (GE): that after an initial evaluation will be subjected to a hypopressive abdominal gymnastics program, for 12 weeks with 2 weekly sessions (Tuesday and Thursday, controlling adherence to the sessions through attendance), with a duration of 45 min per session. Once the intervention is finished, you will be subjected to a final evaluation to see if there is a difference or not with the results obtained at the beginning. |
| Control group | No intervention | –A control group (CG): that will not be subjected to treatment, which will be evaluated in the pre and post phase of the study, and a follow-up by telephone contact of adherence to physical activity. The participants assigned to this group will receive general advice on the positive effects of the regular practice of physical activity aimed at preventing urinary incontinence, and they will be given the guide of recommendations for the promotion of physical activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypopressive interventionHypopressive abdominal gymnastics is based on a basic level hypopressive exercise program that will be: * A duration of 12 weeks with a frequency of 2 sessions a week and lasting 45 minutes each. Hypopressive abdominal exercises will be performed individually adapted to the capacity of the participant. * There will be an initial anatomical training of the muscles involved in carrying out the exercise and practice in the respiratory technique for a duration of 15 minutes. Afterwards, hypopressive exercises will begin for 20-30 minutes, changing positions if possible. | Other | Experimental group |
Primary outcome
International Consulation on Incontinence Short Quality of Life Questionnaire
Time frame: Up to twelve weeks
Is a brief questionnaire aimed at measuring the perception of UI symptoms and the patient's quality of life. The scores of the questions 1+2+3 are added. Any score greater than zero is considered a diagnosis of UI.
PSQI (Pittsburgh Sleep Quality Index)
Time frame: Up to twelve weeks
A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.
Pelvic organ prolapse/urinary incontinence sexual function questionnaire-12
Time frame: Up to twelve weeks
It is an instrument with adequate psychometric characteristics to assess sexual function in women with pelvic floor problems in Spain. The score is made by adding the scores of each item, (from 0=always to 4=never), inverting this score for items 1, 2, 3, and 4.
Prolapse quality of life questionnaire
Time frame: Up to twelve weeks
The P-QoL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health (1 item), prolapse impact (1 item), role limitations (2 items), physical limitations (2 items), social limitations (3 items), personal relationships (2 items), emotions (3 items), sleep/energy (2 items) and severity measures (4 items). Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life. Additionally, there are 18 questions regarding urinary, bowel, and prolapse/vaginal symptoms, which do not have an assigned score. Response options are on a Likert scale with ranges between 1 and 4, except for the first question, that ranges between 1 and 5. Symptoms questions and personal relationships domains offer the option Not applicable.
Handgrip Strength
Time frame: Up to twelve weeks
Dynamometer will be employed to assess hand grip strength.
TUG test (Timed Up and Go test)
Time frame: Up to twelve weeks
Is a simple test used to assess a person's mobility and physical function.
Chair sit and reach test.
Time frame: Up to twelve weeks
To test low back and hamstring flexibility.
Back scratch test.
Time frame: Up to twelve weeks
To measure general shoulder range of motion.
4 secondary outcomes
BMI (Body Mass Index)
Time frame: Up to twelve weeks
Waist circumference.
Time frame: Up to twelve weeks
Hip circumference
Time frame: Up to twelve weeks
Waist-to-hip ratio.
Time frame: Up to twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypopressive intervention in people with Menopause and Older Adults, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consulation on Incontinence Short Quality of Life Questionnaire (time frame: Up to twelve weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.