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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 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

15000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Inny: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Prevalence and severity of menopause-related symptoms assessed by the Menopause-Specific Quality of Life Questionnaire
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Association between physical activity level and menopause-related symptom prevalence and severity
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Cuerpos Serranos S.L.

Współpracownicy

Universidad Politecnica de Madrid

Śledczy

  • Główny śledczy: María Ángeles García, PhD, Cuerpos Serranos S.L.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 kwietnia 2026

Zakończenie podstawowe (Szacowany)

1 września 2026

Ukończenie studiów (Szacowany)

1 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

5 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 maja 2026

Pierwszy wysłany (Rzeczywisty)

19 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ABPL-20260311

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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