Prevalence of Menopause-associated Symptoms Throughout the Menopausal Transition in Women Aged 40 to 70 Residing in Spain and Its Relationship With Physical Activity - MdH Study

Официальное название

Prevalence of Menopause-associated Symptoms Throughout the Menopausal Transition in Women Aged 40 to 70 Residing in Spain and Its Relationship With Physical Activity.

Обзор

The goal of this observational study is to learn about menopause-related symptoms in women aged 40 to 70 years who live in Spain. The study will also look at whether physical activity, body weight, health history, social factors, and risk of osteoporotic fracture are linked to these symptoms. Menopause-related symptoms can affect daily life, sleep, mood, sexual health, and physical well-being. These symptoms may be different depending on whether a woman is in premenopause, perimenopause, or postmenopause. This study aims to better understand these symptoms in women living in Spain and to explore whether women who are more physically active report fewer or less bothersome symptoms. The main questions this study aims to answer are: How common are menopause-related symptoms in women aged 40 to 70 years who live in Spain? Do symptoms differ between women in premenopause, perimenopause, and postmenopause? Are women with higher levels of physical activity less likely to report bothersome menopause-related symptoms? Are body weight, age, health history, social factors, or osteoporotic fracture risk linked to more bothersome symptoms? Can the study identify groups of women who may be more likely to have a higher symptom burden? Participants will complete an online survey one time. The survey will take about 15 to 25 minutes. Participants will answer questions about: Age, place of residence, education, work situation, and other personal information Weight and height Menstrual history and reproductive history Current menopause stage Health history and current treatments Tobacco and alcohol use Type, amount, and setting of physical activity Time spent sitting Menopause-related symptoms during the last month Factors related to osteoporotic fracture risk, such as previous fractures, family history of hip fracture, smoking, alcohol use, use of corticosteroids, rheumatoid arthritis, and other health conditions The survey will include three standard questionnaires. The Menopause-Specific Quality of Life Questionnaire will ask about symptoms in four areas: hot flashes and sweating, mood and social well-being, physical symptoms, and sexual health. The International Physical Activity Questionnaire will ask about physical activity during the last 7 days, including activity at work, transport, household tasks, leisure time, and time spent sitting. The Fracture Risk Assessment Tool will estimate the risk of osteoporotic fracture using clinical risk factors. This is an observational study. Researchers will not assign participants to any treatment, exercise program, or medical care. The study will collect information through online questionnaires and will analyze links between menopause-related symptoms, physical activity, fracture risk, and other participant characteristics.

Вмешательства

• Другое Reproductive stage
  Participants will be classified according to the Stages of Reproductive Aging Workshop + 10 criteria. Based on self-reported menstrual history and reproductive information, participants will be classified as being in premenopause, early perimenopause, late perimenopause, early postmenopause, or late postmenopause. Reproductive stage will be analyzed as an exposure of interest in relation to menopause-related symptoms, physical activity, and osteoporotic fracture risk.
• Поведенческое Physical Activity Level
  Physical activity will not be assigned by the researchers. Participants will report their usual physical activity during the last 7 days using the International Physical Activity Questionnaire (long version). Physical activity will be analyzed as an exposure of interest in relation to menopause-related symptoms.

Первичные конечные точки

• Prevalence and severity of menopause-related symptoms assessed by the Menopause-Specific Quality of Life Questionnaire [Срок оценки: At baseline, through one online survey]

Вторичные конечные точки (2)

• Association between physical activity level and menopause-related symptom prevalence and severity [Срок оценки: At baseline, through one online survey]
• Association between exercise type and frequency and menopause-related symptom prevalence and severity [Срок оценки: At baseline, through one online survey]

Критерии участия

Критерии включения

• Female sex.
• Age 40 to 70 years.
• Residence in Spain.
• Ability to understand and complete the online questionnaire.

Критерии исключения

• Failure to provide electronic informed consent.
• Inability to understand the study information or complete the online questionnaire in Spanish.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 2 центра

• Cuerpos Serranos S.L. — Madrid
• Universidad Politécnica de Madrid — Madrid

Идентификаторы

NCT: NCT07596069 · ABPL-20260311

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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