Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06419972
Other study ID # UV_Menopause
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 30, 2024
Est. completion date February 28, 2025

Study information

Verified date May 2024
Source University of Valencia
Contact Laura Fuentes-Aparicio, PhD
Phone 669682391
Email laura.fuentes@uv.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 115
Est. completion date February 28, 2025
Est. primary completion date December 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 85 Years
Eligibility Inclusion Criteria: - Women aged =45 years - Women in climacteric period Exclusion Criteria: - 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.

Study Design


Intervention

Other:
multimodal physiotherapy programme
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.

Locations

Country Name City State
Spain Laura Fuentes Aparicio Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
Primary 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). 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
Primary 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). 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
Primary 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. 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
Primary 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. 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Primary 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) . 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Primary 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. 8 weeks (2 assesment times: T1(pre-intervention), T2 (Inmediately post-intervention) and T3 (3-months follow-up)
Primary 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. 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)
Primary 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. 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Secondary 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.
8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Secondary 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. 8 weeks (2 assessent times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Secondary 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. 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)
Secondary 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. 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
See also
  Status Clinical Trial Phase
Completed NCT04553029 - A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
Completed NCT03672513 - Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04210583 - RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Completed NCT05617287 - An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause N/A
Recruiting NCT05180266 - Therapeutic Touch and Music in The Menopausal Period N/A
Recruiting NCT04043520 - Bioenergetic Effects of Aging and Menopause (BEAM) Phase 4
Completed NCT03663075 - Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women N/A
Completed NCT03363997 - Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days Phase 1
Not yet recruiting NCT04724135 - Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
Not yet recruiting NCT04728126 - Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
Completed NCT02274571 - Raising Insulin Sensitivity in Post Menopause Early Phase 1
Completed NCT02253173 - Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Recruiting NCT01488903 - A Cohort Research of Genetic Susceptibility for Common Obesity in Women N/A
Terminated NCT01633814 - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women N/A
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A