NCT07500922

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
21mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Apr 2026Mar 2028

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

April 25, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 24, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

cortico-reticularcentral nervous systemphysical performancestrength

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

EXPERIMENTAL

The 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).

Behavioral: Physical training

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.

HRT+training

Eligibility Criteria

Age50 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

RECRUITING

Related Links

MeSH Terms

Interventions

Physical Conditioning, Human

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Simon Walker, PhD

    Universirty of Jyväskylä, Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Walker Dr (Dos.), PhD

CONTACT

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.

Locations