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

NCT07596069 | Recruiting

• 1 other identifier: ABPL-20260311
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Menopausal Symptoms; Physical Activity and Sedentary Behavior

Keywords

Menopausal Symptoms; Women Reproductive Stages; Menopause; Perimenopause; Women's health; Spanish Women; Physical activity; Menopause transition; Vasomotor symptoms; Mood symptoms; Osteoporotic fracture risk; IPAQ; MENQOL; FRAX; Exercise habits

Outcome Measures

Primary Outcomes (1)

• Prevalence and severity of menopause-related symptoms assessed by the Menopause-Specific Quality of Life Questionnaire

  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

Secondary Outcomes (2)

• Association between physical activity level and menopause-related symptom prevalence and severity

  At baseline, through one online survey

• Association between exercise type and frequency and menopause-related symptom prevalence and severity

  At baseline, through one online survey

Study Arms (1)

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.

Other: Reproductive stage; Behavioral: Physical Activity Level

Interventions

Reproductive stage OTHER

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.

Women aged 40 to 70 years living in Spain

Physical Activity Level BEHAVIORAL

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.

Women aged 40 to 70 years living in Spain

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 the Stages of Reproductive Agi

You may qualify if:

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

You may not qualify if:

• Residence outside Spain.
• Age below 40 years or above 70 years.
• Difficulty understanding the study information or questionnaire.

Sponsors & Collaborators

• Cuerpos Serranos S.L.: lead
• Universidad Politecnica de Madrid: collaborator

Study Sites (2)

Cuerpos Serranos S.L.

Madrid, Spain

RECRUITING

Universidad Politécnica de Madrid

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• María Ángeles García, PhD

  Cuerpos Serranos S.L.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Belén Peinado, PhD

CONTACT

910677988; anabelen.peinado@upm.es

Javier Butragueño, PhD

CONTACT

648785150; javier.butragueno@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 19, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)