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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

27 de julho de 2026 atualizado por: Cuerpos Serranos S.L.

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

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Observacional

Inscrição (Estimado)

15000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

The study population will include women aged 40 to 70 years who live in Spain. Participants will be recruited from the community through online dissemination channels, including institutional websites, social media, digital communication channels, press announcements, links, and QR codes. Interested women will access the study website, review the study information, provide electronic informed consent, and complete the online questionnaire.

Participants will be classified by reproductive stage using the Stages of Reproductive Aging Workshop + 10 criteria, based on self-reported menstrual and reproductive information collected in the questionnaire. Categories will include premenopause, early perimenopause, late perimenopause, early postmenopause, and late postmenopause.

Some participants may not be classifiable into a reproductive stage based only on questionnaire data. This may occur when the available self-reported information is not sufficient to apply STRAW+10.

Descrição

Inclusion Criteria:

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

Exclusion Criteria:

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Women aged 40 to 70 years living in Spain
Participants will complete one online survey about menopause-related symptoms, physical activity, reproductive and menstrual history, health history, anthropometric information, lifestyle factors, and osteoporotic fracture risk. For the primary outcome analysis, participants will be classified into five reproductive stage groups using the Stages of Reproductive Aging Workshop + 10 criteria: premenopause, early perimenopause, late perimenopause, early postmenopause, and late postmenopause.
Outro: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Prevalence and severity of menopause-related symptoms assessed by the Menopause-Specific Quality of Life Questionnaire
Prazo: At baseline, through one online survey
Menopause-related symptoms will be assessed using the Menopause-Specific Quality of Life Questionnaire. This questionnaire evaluates symptoms across four domains: vasomotor, psychosocial, physical, and sexual. For each domain, researchers will describe symptom prevalence, defined as the proportion of participants reporting one or more symptoms, and symptom severity, based on the level of bother reported by participants for each symptom. Domain scores will be analyzed separately, and an overall symptom score may also be analyzed when appropriate.
At baseline, through one online survey

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Association between physical activity level and menopause-related symptom prevalence and severity
Prazo: At baseline, through one online survey
The association between physical activity level and menopause-related symptom prevalence and severity will be assessed using the International Physical Activity Questionnaire and the Menopause-Specific Quality of Life Questionnaire. Physical activity will be measured during the last 7 days and expressed as metabolic equivalent task minutes per week. Participants will also be classified as having low, moderate, or high physical activity according to International Physical Activity Questionnaire scoring rules. This outcome will assess whether menopause-related symptom prevalence and severity differ according to overall physical activity level.
At baseline, through one online survey
Association between exercise type and frequency and menopause-related symptom prevalence and severity
Prazo: At baseline, through one online survey
The association between exercise type and frequency and menopause-related symptom prevalence and severity will be assessed using self-reported exercise questions and the Menopause-Specific Quality of Life Questionnaire. Participants will report whether they perform regular exercise, the main type of exercise they do, and the number of days per week they perform aerobic exercise and/or strength exercise. Exercise type will be classified as no regular exercise, mainly aerobic exercise, mainly strength exercise, or combined aerobic and strength exercise. This outcome will assess whether menopause-related symptom prevalence and severity differ according to exercise type and weekly exercise frequency.
At baseline, through one online survey

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cuerpos Serranos S.L.

Colaboradores

Universidad Politecnica de Madrid

Investigadores

  • Investigador principal: María Ángeles García, PhD, Cuerpos Serranos S.L.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de abril de 2026

Conclusão Primária (Estimado)

1 de setembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

5 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2026

Primeira postagem (Real)

19 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ABPL-20260311

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be made publicly available because the study collects sensitive health, reproductive, and lifestyle information. Study results will be shared in aggregate and anonymized form through scientific publications and presentations.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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