Clinical trial NCT06419972: Multimodal Program for Climacteric Women
Official title: Effectiveness of a Combined Education and Exercise Program on the Physical, Functional and Psychological Status of Climacteric Women.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Climacteric Syndrome
Postmenopausal Symptoms
Menopause
Perimenopausal Disorder
Keywords: perimenopause
climacteric
Postmenopause
women's health
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 115
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Upper limb muscle strength
timeFrame: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
measure: Lower limb muscle strength
timeFrame: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
measure: Trunk flexor isometric strength
timeFrame: 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
measure: Abdominopelvic muscle function
timeFrame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
measure: Abdominal ultrasound image
timeFrame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
measure: Pelvic floor muscle ultrasound image
timeFrame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
measure: 30s chair-stand test
timeFrame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Inmediately post-intervention) and T3 (3-months follow-up)
measure: Pelvic floor muscles strength
timeFrame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)
measure: Pelvic floor muscles Dynamometry
timeFrame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Secondary outcomes:
measure: Menopause symptoms
timeFrame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
measure: Psychologic condition
timeFrame: 8 weeks (2 assessent times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
measure: Urinary symptoms
timeFrame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)
measure: Pelvic floor health knowledge
timeFrame: 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Department of Physiotherapy. University of Valencia
city: Valencia
country: Spain
facility: Laura Fuentes Aparicio
Study officials:
References: