Climacteric SyndromeNCT06419972
Multimodal Program for Climacteric Women
A study testing multimodal physiotherapy programme in people with Climacteric Syndrome and Postmenopausal Symptoms, run by University of Valencia at 2 sites in Spain.
Trial summary
Your study seems to aim at emphasizing the significance of non-pharmacological and non-hormonal approaches in managing menopausal symptoms, particularly focusing on muscle training and education. Read more about this study
- Who is it for?
- Ages 45 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Climacteric Syndrome, Postmenopausal Symptoms, Menopause
- What is being tested?
- multimodal physiotherapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesSpain
- Study dates
- 30 May 2024to 28 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged ≥45 years
- Women in climacteric period
Who cannot join
- Musculoskeletal, cognitive, infectious, neurological, or cardiorespiratory pathology impairing assessment or program completion.
- Surgical intervention in lumbopelvic or gynecological region within the last 6 months.
- Undergoing oncological treatment.
- Also included women with stable hormone replacement therapy for at least the last 6 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Department of Physiotherapy. University of Valencia
Valencia, 46010
Laura Fuentes Aparicio, PhD, 669682391, laura.fuentes@uv.es
Laura Fuentes Aparicio, PhD
- Not yet recruiting
Laura Fuentes Aparicio
Valencia, 46010
Laura Fuentes-Aparicio, PT PhD, 669682391, laura.fuentes@uv.es
About this study
Official title: Effectiveness of a Combined Education and Exercise Program on the Physical, Functional and Psychological Status of Climacteric Women.
Your study seems to aim at emphasizing the significance of non-pharmacological and non-hormonal approaches in managing menopausal symptoms, particularly focusing on muscle training and education. This holistic approach acknowledges the importance of physical well-being, psychological support, and education to enhance women's quality of life during the menopausal transition.
Read the detailed description
Climacteric is a time of great transition for all women physically, mentally, and emotionally . This transition involves a host of physical, endocrine, and psychological changes that are influenced by ethnic, psychological, and sociocultural factors . Each woman's experience of the menopausal transition is unique; therefore, a one-size-fits-all approach to symptom management is not sufficient .
Menopause is a retrospective diagnosis and is said to occur when menstrual activity has ceased for at least 12 consecutive months with no other physiologic or pathologic explanation for it . It marks the end of reproductive life and ovarian follicular activity by the onset of an estrogen deficiency that triggers various symptoms .
The main symptoms aggregated according to the Menopause Rating Score MRS include somatic symptoms [vasomotor symptoms (hot flashes and night sweats), sleeping difficulties, fatigue, palpitations, joint pain, worsening muscle ability and function, skin/eye dryness, and skin and hair changes], psychological [mental confusion, mood swings, increased anxiety, irritability], and urogenital [genitourinary syndrome symptoms (vaginal dryness, dyspareunia, irritation, itching, sexual dysfunction), bladder symptoms (altered frequency, level of urgency and incontinence).
Focusing on the musculature and ligaments, we must also think about the tissues of the pelvic floor muscle (PFM), which are affected by the drop in estrogen levels, due to the existence of estrogen receptors in ligaments, musculature and pelvic support structures. The pelvic floor as a whole has an important role in supporting the organs of the pelvic cavity and is involved in the closing and opening mechanisms of the urethral, vaginal and anal tract . Taking this into account, what can be worked on voluntarily is the musculature.
This estrogenic variation is also responsible for the onset of cardiovascular disease during the menopausal period, which is characterized by variations in the lipid profile and the predominant accumulation of abdominal fat.
Treatments to treat menopausal symptoms include hormonal preparations, non-hormonal medications and non-pharmacological therapies. The latter two, non-pharmacological and non-hormonal therapies are generally the least studied.
On genitourinary and urinary syndrome symptoms, the musculature has a fundamental role, and working on it will produce improvements in these factors. By training the pelvic floor muscle (PFM) there is a greater blood supply, which this will lead to a relaxation of the tissues and an increase in elasticity that will help in the genitourinary syndrome; and on the other hand, its training, increasing strength, will improve the control and efficacy of the closing and opening of the urethral, vaginal and anal tracts .
On the other hand, physical activity will help in weight loss and improve body composition parameters .
It should be noted that the information provided to women influences the understanding and how menopause and its symptoms are faced, being relevant to provide knowledge and education by the general practitioner or a qualified health personnel.
Therefore, this study seeks to expand the information on non-pharmacological and non-hormonal therapies, such as active training of the pelvic floor muscle, generic muscle training and education, due to their potential efficacy.
- Being tested
- multimodal physiotherapy programme
- Keywords
- perimenopause, climacteric, Postmenopause, women's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal physiotherapy programmeOther
The intervention to which the climacteric women will be subjected will consist of a combined program of education and general strength and pelvic floor muscles exercises of 8 weeks duration, at a rate of 2 sessions/week. Each of the sessions will last 60 min, except for the first one, which will be 90 min.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | They will receive multimodal physiotherapy programme, which will combine therapeutic exercise based in general strength exercise combined with a pelvic floor education program. Receives: Other: multimodal physiotherapy programme |
| Control | No intervention | They will not receive any type of intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb muscle strength
For performed the upper limb muscle strength (kg) evaluation will use different dynamometry test
Dynamometry of Upper limb muscle: using the Hand grip strength (stable position - elbow 90º and arm in contact with the trunk , hold dynamometer with the hand and perform maximum grip force for 5seconds.
Measured: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
Lower limb muscle strength
The quadriceps dynamometry test (Lafayette Instrument) will be used to evaluate the muscular strength of the lower extremities, the unit of measure will be. The Lafayette measuring range is 0-300 lbs (136.1 kg/1335 N).
Measured: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
Trunk flexor isometric strength
For the isometric strength of the trunk flexors, the central dynamometry test (Lafayette Instrument) will be used: the patient will be in the supine position with the knees straight, the hips flexed at 30° and the trunk at 30°; placing the dynamometer on the sternum, below the suprasternal notch, the participants should place their hands on the opposite acromion processes.The Lafayette measuring range is 0-300 lbs (136.1 kg/1335 N).
Measured: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
Abdominopelvic muscle function
The Supine Bridge Test involves lying on a mat with knees and hips flexed, lifting the pelvis off the floor for alignment. The Prone Bridge requires lying face down on elbows, lifting the pelvis so only forearms and toes touch the floor. In the Side Bridge, one lies on their side, supporting the body with elbow, forearm, and feet while lifting the hips. Participants hold each position as long as possible to assess core strength and stability.
Measured: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
Abdominal ultrasound image
Will be measure abdominal wall thickness at rest and during a draw-in maneuver for Transversus abdominis (TrA), obliquus internus (IO), and obliquus externus (EO) on the dominant side. Subjects will lie supine with hips and knees flexed. Using a 5.3-10 MegaHertz (MHz) linear probe, the transducer will be centered transversely just above the iliac crest at the umbilical level and aligned with the axillary midline. Three measurements will be taken at each point, averaged for analysis, with the M-line set to the midline for precise measurements. Changes in muscle thickness (cm) reflecting muscle activation will be observed.
Measured: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Pelvic floor muscle ultrasound image
Transabdominal ultrasound will be used, for this purpose convex probe will be place at suprapubic level in B-mode will be used (3.5-5MegaHertz (Mhz). Three measurements at each point and use the mean of the 3 for subsequent analyses. Changes in muscle thickness refected by muscle activation will be calculated as the thickness during contraction minus the resting thickness (cm) .
Measured: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
30s chair-stand test
Women will start from a seated position with feet flat on the floor and arms crossed, rise completely with hips and knees extended, then sit back down touching the seat, repeat for 30 seconds. Chair leaning against a wall, usual footwear. If unable to stand, hands can be placed on legs or mobility aids can be used, scored as adapted test. It is recommended to practice 2-3 slow repetitions for comprehension. Scoring: Count the total number of complete bipedestation (up and down) in a test. If at least one bipedestation is completed in 30 seconds, it is counted. If unable to stand, the score is zero. Record the adapted score if applicable.
Measured: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Inmediately post-intervention) and T3 (3-months follow-up)
Pelvic floor muscles strength
Vaginal palpation will be done using the Modified Oxford Scale, which comprises 6 levels. It demonstrates good interobserver reliability and serves as a subjective scale for clinical rather than research purposes. To gauge sensitivity to change, each point was supplemented with a +/-, expanding the scale to include 15 degrees.
Measured: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)
Pelvic floor muscles Dynamometry
A commercially available instrumented plastic dynamometric speculum (Pelvimeter, Phenix, Montpellier, France) was utilized to measure pelvic floor muscle (PFM) tone and maximum intravaginal pelvic floor muscle (PFM) strength generated through maximal voluntary contraction the measure will be reported in grams. All numerical values of pelvic floor muscle (PFM) dynamometry tone are presented as raw values, including the ambient pressure value (170 g). Latex or polyethylene protective covers were used, and the dynamometer was comfortably aligned in the participant's vaginal canal throughout the experiment. Pelvic floor muscle strength was calculated as the mean of three maximum voluntary contractions.
Measured: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Secondary outcomes (4)
Menopause symptoms
The Menopause Rating Scale (MRS) is a widely used tool for assessing symptoms related to menopause.
The scoring scheme increases point by point with increasing subjectively perceived symptom severity for each of the 11 items (severity 0 [no complaint] to 4 score points [very severe symptoms]). The composite score for each of the dimensions (subscales) is based on the sum of the scores for each item of the respective dimensions. The composite score (total score) is the sum of the dimension scores.
Measured: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Psychologic condition
The Beck Depression Inventory (BDI) is a widely used self-report inventory for measuring the severity of depression symptoms. It consists of 21 multiple-choice questions, each assessing a different symptom of depression such as sadness, pessimism, guilt, and suicidal thoughts. Respondents rate the severity of each symptom over the past two weeks. Scores are summed to yield a total score, with higher scores indicating more severe depressive symptoms. The BDI is frequently used in clinical and research settings to assess depression severity and monitor treatment progress.
Measured: 8 weeks (2 assessent times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Urinary symptoms
The Pelvic Floor Distress Inventory-20 (PFDI-20) is a recommended questionnaire for evaluating pelvic floor disorder (PFD) symptoms and measuring their impact on women's quality of life. This questionnaire is validated in Spanish. The PFDI-20 reflects different perspectives, thus including 20 questions divided into three symptom scales: pelvic organ prolapse symptoms (POP-DI) (questions 1 to 6); colorectal-anal symptoms (CRADI) (questions 7-14); and urinary symptoms (UDI) (questions 15-20). The questions in the CRADI scale are about fecal incontinence (FI), except for question 11, which addresses flatulence incontinence; whereas the UDI scale addresses urinary symptoms specifically. Question 16 pertains to urgency urinary incontinence (UUI), and question 17 pertains to stress urinary incontinence (SUI). Each question can be answered on four levels of dysfunction: none, mild, moderate, and severe.
Measured: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)
Pelvic floor health knowledge
Pelvic Floor Impact Questionnaire (PIKQ)It is a tool used to assess the impact of pelvic floor disorders, such as urinary incontinence, colorectal-anal symptoms, and genital prolapse, on various aspects of a person's life, including activities, relationships, and emotions. The questionnaire consists of seven questions for each symptom category (urine, colorectal-anal, and genital prolapse), with responses rated on a scale of none, mild, moderate, or severe. The total score is calculated by summing the scores from each category, with a maximum possible score of 300.
Measured: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start30 May 2024
- Primary completion25 Oct 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climacteric SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Fuentes Aparicio, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419972
- Sponsor's protocol ID
- UV_Menopause
- Status last verified
- May 2026
- First submitted
- 7 May 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Education and Exercise Program on the Physical, Functional and Psychological Status of Climacteric Women.
- ClinicalTrials.gov ID
- NCT06419972
- Acronym / sponsor ID
- UV_Menopause
- Keywords
- perimenopause, climacteric, Postmenopause, women's health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 17 May 2024 (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.
Your study seems to aim at emphasizing the significance of non-pharmacological and non-hormonal approaches in managing menopausal symptoms, particularly focusing on muscle training and education. This holistic approach acknowledges the importance of physical well-being, psychological support, and education to enhance women's quality of life during the menopausal transition.
Detailed description
Climacteric is a time of great transition for all women physically, mentally, and emotionally . This transition involves a host of physical, endocrine, and psychological changes that are influenced by ethnic, psychological, and sociocultural factors . Each woman's experience of the menopausal transition is unique; therefore, a one-size-fits-all approach to symptom management is not sufficient .
Menopause is a retrospective diagnosis and is said to occur when menstrual activity has ceased for at least 12 consecutive months with no other physiologic or pathologic explanation for it . It marks the end of reproductive life and ovarian follicular activity by the onset of an estrogen deficiency that triggers various symptoms .
The main symptoms aggregated according to the Menopause Rating Score MRS include somatic symptoms [vasomotor symptoms (hot flashes and night sweats), sleeping difficulties, fatigue, palpitations, joint pain, worsening muscle ability and function, skin/eye dryness, and skin and hair changes], psychological [mental confusion, mood swings, increased anxiety, irritability], and urogenital [genitourinary syndrome symptoms (vaginal dryness, dyspareunia, irritation, itching, sexual dysfunction), bladder symptoms (altered frequency, level of urgency and incontinence).
Focusing on the musculature and ligaments, we must also think about the tissues of the pelvic floor muscle (PFM), which are affected by the drop in estrogen levels, due to the existence of estrogen receptors in ligaments, musculature and pelvic support structures. The pelvic floor as a whole has an important role in supporting the organs of the pelvic cavity and is involved in the closing and opening mechanisms of the urethral, vaginal and anal tract . Taking this into account, what can be worked on voluntarily is the musculature.
This estrogenic variation is also responsible for the onset of cardiovascular disease during the menopausal period, which is characterized by variations in the lipid profile and the predominant accumulation of abdominal fat.
Treatments to treat menopausal symptoms include hormonal preparations, non-hormonal medications and non-pharmacological therapies. The latter two, non-pharmacological and non-hormonal therapies are generally the least studied.
On genitourinary and urinary syndrome symptoms, the musculature has a fundamental role, and working on it will produce improvements in these factors. By training the pelvic floor muscle (PFM) there is a greater blood supply, which this will lead to a relaxation of the tissues and an increase in elasticity that will help in the genitourinary syndrome; and on the other hand, its training, increasing strength, will improve the control and efficacy of the closing and opening of the urethral, vaginal and anal tracts .
On the other hand, physical activity will help in weight loss and improve body composition parameters .
It should be noted that the information provided to women influences the understanding and how menopause and its symptoms are faced, being relevant to provide knowledge and education by the general practitioner or a qualified health personnel.
Therefore, this study seeks to expand the information on non-pharmacological and non-hormonal therapies, such as active training of the pelvic floor muscle, generic muscle training and education, due to their potential efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: multimodal physiotherapy programmeThey will receive multimodal physiotherapy programme, which will combine therapeutic exercise based in general strength exercise combined with a pelvic floor education program. |
| Control | No intervention | –They will not receive any type of intervention |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged ≥45 years
- Women in climacteric period
Key exclusion criteria (4 listed)
- Musculoskeletal, cognitive, infectious, neurological, or cardiorespiratory pathology impairing assessment or program completion.
- Surgical intervention in lumbopelvic or gynecological region within the last 6 months.
- Undergoing oncological treatment.
- Also included women with stable hormone replacement therapy for at least the last 6 months.
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 |
|---|---|---|
| multimodal physiotherapy programmeThe intervention to which the climacteric women will be subjected will consist of a combined program of education and general strength and pelvic floor muscles exercises of 8 weeks duration, at a rate of 2 sessions/week. Each of the sessions will last 60 min, except for the first one, which will be 90 min. | Other | Experimental |
Primary outcome
Upper limb muscle strength
Time frame: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
For performed the upper limb muscle strength (kg) evaluation will use different dynamometry test Dynamometry of Upper limb muscle: using the Hand grip strength (stable position - elbow 90º and arm in contact with the trunk , hold dynamometer with the hand and perform maximum grip force for 5seconds.
Lower limb muscle strength
Time frame: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
The quadriceps dynamometry test (Lafayette Instrument) will be used to evaluate the muscular strength of the lower extremities, the unit of measure will be. The Lafayette measuring range is 0-300 lbs (136.1 kg/1335 N).
Trunk flexor isometric strength
Time frame: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
For the isometric strength of the trunk flexors, the central dynamometry test (Lafayette Instrument) will be used: the patient will be in the supine position with the knees straight, the hips flexed at 30° and the trunk at 30°; placing the dynamometer on the sternum, below the suprasternal notch, the participants should place their hands on the opposite acromion processes.The Lafayette measuring range is 0-300 lbs (136.1 kg/1335 N).
Abdominopelvic muscle function
Time frame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
The Supine Bridge Test involves lying on a mat with knees and hips flexed, lifting the pelvis off the floor for alignment. The Prone Bridge requires lying face down on elbows, lifting the pelvis so only forearms and toes touch the floor. In the Side Bridge, one lies on their side, supporting the body with elbow, forearm, and feet while lifting the hips. Participants hold each position as long as possible to assess core strength and stability.
Abdominal ultrasound image
Time frame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Will be measure abdominal wall thickness at rest and during a draw-in maneuver for Transversus abdominis (TrA), obliquus internus (IO), and obliquus externus (EO) on the dominant side. Subjects will lie supine with hips and knees flexed. Using a 5.3-10 MegaHertz (MHz) linear probe, the transducer will be centered transversely just above the iliac crest at the umbilical level and aligned with the axillary midline. Three measurements will be taken at each point, averaged for analysis, with the M-line set to the midline for precise measurements. Changes in muscle thickness (cm) reflecting muscle activation will be observed.
Pelvic floor muscle ultrasound image
Time frame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Transabdominal ultrasound will be used, for this purpose convex probe will be place at suprapubic level in B-mode will be used (3.5-5MegaHertz (Mhz). Three measurements at each point and use the mean of the 3 for subsequent analyses. Changes in muscle thickness refected by muscle activation will be calculated as the thickness during contraction minus the resting thickness (cm) .
30s chair-stand test
Time frame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Inmediately post-intervention) and T3 (3-months follow-up)
Women will start from a seated position with feet flat on the floor and arms crossed, rise completely with hips and knees extended, then sit back down touching the seat, repeat for 30 seconds. Chair leaning against a wall, usual footwear. If unable to stand, hands can be placed on legs or mobility aids can be used, scored as adapted test. It is recommended to practice 2-3 slow repetitions for comprehension. Scoring: Count the total number of complete bipedestation (up and down) in a test. If at least one bipedestation is completed in 30 seconds, it is counted. If unable to stand, the score is zero. Record the adapted score if applicable.
Pelvic floor muscles strength
Time frame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)
Vaginal palpation will be done using the Modified Oxford Scale, which comprises 6 levels. It demonstrates good interobserver reliability and serves as a subjective scale for clinical rather than research purposes. To gauge sensitivity to change, each point was supplemented with a +/-, expanding the scale to include 15 degrees.
Pelvic floor muscles Dynamometry
Time frame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
A commercially available instrumented plastic dynamometric speculum (Pelvimeter, Phenix, Montpellier, France) was utilized to measure pelvic floor muscle (PFM) tone and maximum intravaginal pelvic floor muscle (PFM) strength generated through maximal voluntary contraction the measure will be reported in grams. All numerical values of pelvic floor muscle (PFM) dynamometry tone are presented as raw values, including the ambient pressure value (170 g). Latex or polyethylene protective covers were used, and the dynamometer was comfortably aligned in the participant's vaginal canal throughout the experiment. Pelvic floor muscle strength was calculated as the mean of three maximum voluntary contractions.
4 secondary outcomes
Menopause symptoms
Time frame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Psychologic condition
Time frame: 8 weeks (2 assessent times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Urinary symptoms
Time frame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)
Pelvic floor health knowledge
Time frame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal physiotherapy programme in people with Climacteric Syndrome and Postmenopausal Symptoms, run by University of Valencia at 2 sites 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Fuentes-Aparicio, PhD (669682391 ext. 51227, laura.fuentes@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb muscle strength (time frame: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)). The study lists 9 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 19 May 2026.