Menopause Effects on Cortico-reticular Functioning
MENSA
Female Sex Hormone and Menopause Effects on Cortico-reticular Functioning
1 other identifier
interventional
20
1 country
1
Brief Summary
Post-menopausal women who request to begin hormone-replacement therapy (HRT) are directed to the research team. The participants are tested before beginning HRT, after two months of HRT, and five months of HRT. Tests include strength performance, central nervous system functioning, body composition, resting metabolic rate, and vascular screening. The participants are provided a 12-week training intervention (2 x strength, 2 x endurance per week) that can be voluntarily followed between tests at month 2 and 5. Compliance with the training program is recorded. A minimum of 15 participants are needed a priori, but the investigators aim to recruit and test 20 women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2026
CompletedFirst Posted
Study publicly available on registry
March 30, 2026
CompletedStudy Start
First participant enrolled
April 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
May 1, 2026
March 1, 2026
1.7 years
March 24, 2026
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Short-interval intracortical inhibition (SICI)
Ten double-pulse transcranial magnetic stimulations delivered with 3 ms inter-stimulus interval. The conditioning pulse delivered at 80% of active motor threshold and the test pulse delivered at 120% of active motor threshold. Motor-evoked potential amplitude compared to single-pulse responses at 120% of active motor threshold.
Change from baseline to month 2 and change from baseline to month 5
Secondary Outcomes (18)
Motor-evoked potential recruitment curve
Change from baseline to month 2 and change from baseline to month 5
StartleTMS
Change from baseline to month 2 and change from baseline to month 5
Intra-cortical facilitation (ICF)
Change from baseline to month 2 and change from baseline to month 5
Long-interval intracortical inhibition (LICI)
Change from baseline to month 2 and change from baseline to month 5
Motor-evoked potential to anterior-posterior current
Change from baseline to month 2 and change from baseline to month 5
- +13 more secondary outcomes
Study Arms (1)
HRT+training
EXPERIMENTALThe first phase follows the effect of HRT, the second phase follows the effects of HRT+physical training intervention (and compliance to the non-supervised intervention).
Interventions
A 12-week, 4 x per week (2 x strength and 2 x endurance) training program to be performed voluntarily by the participants after tests at month 2.
Eligibility Criteria
You may qualify if:
- at least 6 months since their last period but no more than being 5 years post-menopausal
- basal follicular-stimulating hormone concentration \> 30 IU/L (confirmed post-recruitment)
- willing to start combined hormonal treatment
- womb and ovaries intact with normal functioning throughout reproductive age
- willing to provide informed consent
You may not qualify if:
- classified as excessively obese via BMI assessment (i.e., \>35 kg/m2)
- intra-uterine device usage during transition to menopause
- cardiovascular or skeletomuscular disease preventing strenuous physical activity
- smoker
- diagnosed psychiatric illness
- epilepsy
- other diagnosed injuries/illness affecting the neuromuscular system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Jyväskylä
Jyväskylä, 40014, Finland
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Walker, PhD
Universirty of Jyväskylä, Finland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr (Dos.)
Study Record Dates
First Submitted
March 24, 2026
First Posted
March 30, 2026
Study Start
April 25, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
May 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared due to privacy regulations and GDPR compliance. Summary results will be published in peer-reviewed journals and presented at scientific conferences. Anonymised data will be made publicly available through the university's JYX platform as per the DMP.