Viewing Study NCT05505266


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Study NCT ID: NCT05505266
Status: COMPLETED
Last Update Posted: 2022-11-14
First Post: 2022-08-15
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Physical and Emotional Coping Variables in Climacteric Women
Sponsor: University of Valencia
Organization:

Study Overview

Official Title: Physical Activity, Quality of Life, Emotional State and Coping Strategies in Climacteric Women.
Status: COMPLETED
Status Verified Date: 2022-11
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: ClimWo
Brief Summary: Introduction: The transition to menopause entails several changes in the biopsychosocial sphere of climacteric women. Compared to other therapies, physical exercise has no side effects, is not costly and can have a positive influence on the symptoms reported by women at this stage. The emotional and physical state of climacteric women is affected by the alterations typical of menopause, deteriorating their quality of life. Likewise, physical exercise improves the associated symptomatology. The objective is to know how the study variables (symptomatology, quality of life, emotional state, physical exercise and level of coping) correlate.

Material and methods: Cross-sectional descriptive observational design with a study population made up of women in the climacteric stage carried out through an anonymous and voluntary survey.
Detailed Description: The climacteric is a progressive period, which lasts for years, before and after menopause, the latter being the physiological stage of aging characterized by the decrease in the follicular function of the ovaries that ends with the cessation of menstrual periods. permanent, a phenomenon associated with the decrease in the production of hormones, as well as the arrest by the ovaries in the release of ovules. Menopause most commonly occurs between the ages of 45 and 55. The climacteric is experienced by each woman in a different way, since it is also influenced by biopsychosocial factors, but the investigators can speak of a common symptomatology typical of the climacteric that groups together vasomotor symptoms such as hot flashes and palpitations, psychological symptoms such as changes in mood, depression, irritability and anxiety, alterations in sleep quality, cognitive symptoms such as memory loss, among others. Among the therapies to alleviate the symptoms associated with menopause, the investigators find estrogenic and non-estrogenic hormonal therapies, inhibitors and physical exercise.

Despite the lack of evidence to support physical exercise as a tool to eradicate symptoms linked to menopause, the investigators can affirm that it relieves both somatic and psychological symptoms, and vasomotor and sexual symptoms to a lesser extent, which is associated with an improvement overall quality of life. In addition, with regular physical activity the investigators will be able to strengthen the musculoskeletal system and improve the quality of life.

The investigators found a scarcity of studies that relate therapeutic exercise as a physiotherapeutic tool in relieving the symptomatology of climacteric women, for this reason the need to study the activity they carry out in this area and know its characteristics is raised, in order to guide future strategies in physiotherapy.

Objective: To know the physical exercise carried out by women in this period, to know the existence of levels of anxiety and depression, Coping level and quality of life.

Material and methods Subjects: Women between 40 and 60 years old. For the development of the study, a questionnaire is prepared, which consists of an initial section with basic questions about personal data and symptomatology referred to by each subject, to later move on to the rest of the sections that will include questions from other validated questionnaires: quality of life using the SF -12; For the emotional state, the Goldberg scale; For physical activity, the International Physical Activity Questionnaire (IPAQ); And for coping level, the Brief COPE inventory.

At the end, 2 questions are included about how often they go to a physical therapist to deal with musculoskeletal pain.

Once the questionnaire is closed, the results will be analyzed using SPSS, which will allow us to contrast hypotheses and generate new ones.

Study Oversight

Has Oversight DMC: False
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?: