Viewing Study NCT06419972



Ignite Creation Date: 2024-05-19 @ 5:33 PM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06419972
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-20
First Post: 2024-05-07

Brief Title: Multimodal Program for Climacteric Women
Sponsor: University of Valencia
Organization: University of Valencia

Study Overview

Official Title: Effectiveness of a Combined Education and Exercise Program on the Physical Functional and Psychological Status of Climacteric Women
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 womens 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 womans 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 skineye 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None