- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596069
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ana Belén Peinado, PhD
- Phone Number: +34 910677988
- Email: anabelen.peinado@upm.es
Study Contact Backup
- Name: Javier Butragueño, PhD
- Phone Number: +34 648785150
- Email: javier.butragueno@gmail.com
Study Locations
-
-
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Madrid, Spain
- Recruiting
- Cuerpos Serranos S.L.
-
Contact:
- Javier Butragueño, PhD
- Phone Number: +34 648785150
- Email: javier.butragueno@gmail.com
-
Contact:
- María Ángeles García, PhD
- Email: info@cuerposserranos.com
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Madrid, Spain
- Recruiting
- Universidad Politécnica de Madrid
-
Contact:
- Ana Belén Peinado, PhD
- Phone Number: +34 910677988
- Email: anabelen.peinado@upm.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
Inclusion Criteria:
- Female sex.
- Age 40 to 70 years.
- Residence in Spain.
- Ability to understand and complete the online questionnaire.
Exclusion Criteria:
- Residence outside Spain.
- Age below 40 years or above 70 years.
- Difficulty understanding the study information or questionnaire.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence and severity of menopause-related symptoms assessed by the Menopause-Specific Quality of Life Questionnaire
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between physical activity level and menopause-related symptom prevalence and severity
Time Frame: 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
Time Frame: 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.
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At baseline, through one online survey
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: María Ángeles García, PhD, Cuerpos Serranos S.L.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABPL-20260311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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