MenopauseMENSANCT07500922
Menopause Effects on Cortico-reticular Functioning
A study testing Physical training in people with Menopause and Hormone Replacement Therapy, run by University of Jyvaskyla at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 59 years, women only
- Conditions the study is for
- Menopause, Hormone Replacement Therapy
- What is being tested?
- Physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 25 Apr 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- does not have any of the exclusion criteria for TMS measurements according to Rossi et al. (2021 Clin Neurophysiol. 132(1):269-306.) (i.e. arterial hypertension, heart attack/seizure history, migraine, pacemaker or cochlear implant or other implanted metal/electronic device)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
University of Jyväskylä
Jyväskylä, 40014
Simon Walker, PhD, +358408054906, simon.walker@jyu.fi
About this study
Official title: Female Sex Hormone and Menopause Effects on Cortico-reticular Functioning
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.
Read the detailed description
Study aim: To determine cortico-reticular functioning during low and high female sex hormone, estrogen and progesterone, concentrations.
Hypothesis: Greater functioning/response during neurophysiological tests will occur in the presence of high compared to low estrogen concentrations accompanying greater force production capacity. In addition, pathways reliant on a greater number of synapses, i.e. cortico-reticulospinal, will demonstrate the greatest difference between hormone concentrations.
Justification: Several studies in monkeys and humans suggest that the methodology employed is sensitive to distinguish between high and low force production capacity. Estrogen is a neurotransmitter agonist exerting its influence at least via glutamate and GABA interneuron functioning, respectively.
The MENSA study is a locally administered trial where volunteers who request to be put on combined hormone replacement therapy will be recruited through cooperation with gynaecologists in the Jyväskylä area. Participants visit the University of Jyväskylä laboratories 1-5 days before beginning treatment (baseline), 2 months after beginning treatment and 5 months after beginning treatment having completed a 12-week non-supervised exercise intervention.
The experimental sessions will be conducted in the morning (beginning at approximately 7 am) following an overnight fast, and the time of the day kept constant for each individual participant (± 1 h). The posteriori measurement of serum follicular-stimulating hormone, estradiol and progesterone concentrations will be used to verify the hormonal status of the participants.
A recent study showed that a sample of 12-15 participants would be expected to lead to moderate-to-large (0.2-0.9) effect sizes in the tests of cortico-cortico and cortico-reticular functioning. The target muscle is the biceps brachii performing voluntary unilateral isometric elbow flexion actions. MENSA aims to recruit 20 females; this attempts to overcome potential reduced sample size through drop-out or measurement/technical error, as well as sufficiency for detection of possible changes in secondary outcome measures.
- Conditions
- Menopause, Hormone Replacement Therapy
- Being tested
- Physical training
- Keywords
- cortico-reticular, central nervous system, physical performance, strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to month 2 and change from baseline to month 5
Secondary outcomes (18)
Motor-evoked potential recruitment curve
Ten transcranial magentic stimulations (single-pulse) at 100%, 120%, 140%, 160%, 180% and 200% of active motor threshold. Calculations of I50 and area-under-the-recruitment-curve to be performed offline.
Measured: Change from baseline to month 2 and change from baseline to month 5
StartleTMS
Twenty single-pulse transcranial magnetic stimulations delivered using 120% of active motor threshold. Ten stimulations without sound and ten stimulations conditioned by a loud sound (120 dB, 50 Hz) delivered 50 ms prior to TMS discharge.
Measured: Change from baseline to month 2 and change from baseline to month 5
Intra-cortical facilitation (ICF)
Ten double-pulse transcranial magnetic stimulations delivered with 15 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.
Measured: Change from baseline to month 2 and change from baseline to month 5
Long-interval intracortical inhibition (LICI)
Ten double-pulse transcranial magnetic stimulations delivered with 50 ms inter-stimulus interval. The conditioning pulse delivered at 120% of active motor threshold and the test pulse delivered at 120% of active motor threshold. Motor-evoked potential amplitude of the test pulse compared to the amplitude of the conditioning pulse.
Measured: Change from baseline to month 2 and change from baseline to month 5
Motor-evoked potential to anterior-posterior current
The TMS coil is rotated 180 degrees to induce the opposite direction current within the cortex. A new active motor threshold for this coil orientation is first attained and then ten stimulations with 120% and 140% of active motor threshold are delivered. Motor-evoked potential amplitude is analysed offline.
Measured: Change from baseline to month 2 and change from baseline to month 5
StartReact
Reaction test where the participant contracts the biceps brachii upon seeing a flashing white LED light 1 m in front. Ten flashes occur without accompanying sound. Ten flashes occur accompanied by a quiet sound (80 dB, 50 Hz). Ten flashes occur accompanied by a loud sound (120 dB, 50 Hz). The order of the conditions presented is randomized and separated by approximately 8 s. Reaction time is analysed from the presentations of the flash to the beginning (7 SD above baseline) of the voluntary electromyogram burst. The difference in the reactions times between conditions are calculated. Further analyses regarding rate of force development and voluntary EMG amplitude over 0-50 ms from each contraction are assessed.
Measured: Change from baseline to month 2 and change from baseline to month 5
Maximum isometric voluntary contraction (MVC)
Testing is performed under controlled pre-test conditions (10-12 h fast, no vigorous physical activity in the prior 24 h), seated in a thermoneutral room. The participant performs 3-5 isometric elbow flexion actions by maximally contracting the biceps brachii muscle while seated in an electromechanical dynamometer. Force and electromyography (EMG) activity are recorded during the contractions.
Measured: Change from baseline to month 2 and change from baseline to month 5
Resting energy expenditure (i.e. resting metabolic rate)
Measured by Indirect Calorimetry Resting energy expenditure (REE) is measured by indirect calorimetry (ventilated hood; overnight fast 10-12 h; supine, thermoneutral room). After stabilization, VO2 and VCO2 are recorded for ≥20-30 min; a steady-state segment (e.g., ≥5 min with CV <10% and physiologic RQ) is used to compute REE (kcal/day) via the Weir equation, higher values
= higher energy expenditure. Outcome is change from baseline to follow-up (follow-up - baseline); higher positive values = higher increase in energy expenditure. Procedures/quality criteria follow the device manual and the Statistical Analysis Plan (SAP). Per SAP, supportive analyses may adjust for body composition (FFM/FM) or express REE relative to FFM; these do not replace the prespecified analysis of this primary outcome.
Measured: Change from baseline to month 2 and change from baseline to month 5
Total fat mass
Total fat mass (FM) will be measured by bioelectrical impedance analysis (BIA; InBody) under standardized conditions, including a 10-12 h fast before assessment. FM is reported in kg; higher values indicate higher fat mass. The outcome is the change from baseline to the specified follow-up (follow-up - baseline).
Measured: Change from baseline to month 2 and change from baseline to month 5
Fat-free mass
Fat-free mass (FFM) will be measured by bioelectrical impedance analysis (BIA; InBody) under standardized conditions, including a 10-12 h fast before assessment. FFM is reported in kg; higher values indicate higher fat-free mass.
Measured: Change from baseline to month 2 and change from baseline to month 5
Aotic pulse wave velocity
Aortic pulse wave velocity (PWV) will be measured using an oscillometric Arteriograph device under standardized resting conditions, including a 10-12 h fast and avoidance of vigorous physical activity during the previous 24 h.
Measurements are taken supine in a quiet, thermoneutral room. PWV is reported in m/s; higher values indicate greater arterial stiffness.
Measured: Change from baseline to month 2 and change from baseline to month 5
Arterial wave reflection
Augmentation Index (AIx) will be measured using the Arteriograph under the same standardized resting conditions, including a 10-12 h fast and avoidance of vigorous physical activity during the preceding 24 h. AIx is expressed in %; higher values indicate greater arterial wave reflection.
Measured: Change from baseline to month 2 and change from baseline to month 5
Reflection time
Reflection time measured by Arteriograph in standardized rest (as above). ms; shorter RT = faster wave return.
Measured: Change from baseline to month 2 and change from baseline to month 5
Microvascular perfusion
Resting cutaneous microvascular perfusion measured at the forearm using Laser Doppler under standardized resting conditions (10-12 h fast, no vigorous physical activity in prior 24 h, supine, thermoneutral). Perfusion units (PU); higher = higher resting microvascular flow.
Measured: Change from baseline to month 2 and baseline to month 5
Endothelium-Dependent Vasodilation (Laser Doppler, %)
Endothelium-dependent vasodilatory response measured at the forearm using Laser Doppler during standardized forearm occlusion to induce a controlled ischemic stimulus under resting conditions (as above). % change from baseline; higher = better endothelial function.
Measured: Change from baseline to month 2 and change from baseline to month 5
Post-Occlusive Reactive Hyperemia (PORH, %)
Post-occlusive reactive hyperemia measured at the forearm with Laser Doppler under standardized rest (as above). % increase; higher = better microvascular reactivity.
Measured: Change from baseline to month 2 and change from baseline to month 5
Resting Near-Infrared Spectroscopy (NIRS) Tissue Oxygen Saturation (StO2, %)
Near-Infrared Spectroscopy (NIRS)-derived quadriceps StO2 at rest under standardized conditions (10-12 h fast, no vigorous PA in prior 24 h, supine, thermoneutral). %; higher = higher oxygenation.
Measured: Change from baseline to month 2 and change from baseline to month 5
Near-Infrared Spectroscopy (NIRS) Total Hemoglobin (tHb, au)
NIRS-derived tHb signal (during rest). Arbitrary units; marker of local microvascular blood volume.
Measured: Change from baseline to month 2 and change from baseline to month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start25 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Walker, University of Jyvaskyla
- Investigators
- Simon Walker, PhD, Principal investigator, Universirty of Jyväskylä, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500922
- Sponsor's protocol ID
- 203/13.00.04.00/2026
- Acronym
- MENSA
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Sex Hormone and Menopause Effects on Cortico-reticular Functioning
- ClinicalTrials.gov ID
- NCT07500922
- Acronym / sponsor ID
- MENSA / 203/13.00.04.00/2026
- Conditions
- Menopause, Hormone Replacement Therapy
- Keywords
- cortico-reticular, central nervous system, physical performance, strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study aim: To determine cortico-reticular functioning during low and high female sex hormone, estrogen and progesterone, concentrations.
Hypothesis: Greater functioning/response during neurophysiological tests will occur in the presence of high compared to low estrogen concentrations accompanying greater force production capacity. In addition, pathways reliant on a greater number of synapses, i.e. cortico-reticulospinal, will demonstrate the greatest difference between hormone concentrations.
Justification: Several studies in monkeys and humans suggest that the methodology employed is sensitive to distinguish between high and low force production capacity. Estrogen is a neurotransmitter agonist exerting its influence at least via glutamate and GABA interneuron functioning, respectively.
The MENSA study is a locally administered trial where volunteers who request to be put on combined hormone replacement therapy will be recruited through cooperation with gynaecologists in the Jyväskylä area. Participants visit the University of Jyväskylä laboratories 1-5 days before beginning treatment (baseline), 2 months after beginning treatment and 5 months after beginning treatment having completed a 12-week non-supervised exercise intervention.
The experimental sessions will be conducted in the morning (beginning at approximately 7 am) following an overnight fast, and the time of the day kept constant for each individual participant (± 1 h). The posteriori measurement of serum follicular-stimulating hormone, estradiol and progesterone concentrations will be used to verify the hormonal status of the participants.
A recent study showed that a sample of 12-15 participants would be expected to lead to moderate-to-large (0.2-0.9) effect sizes in the tests of cortico-cortico and cortico-reticular functioning. The target muscle is the biceps brachii performing voluntary unilateral isometric elbow flexion actions. MENSA aims to recruit 20 females; this attempts to overcome potential reduced sample size through drop-out or measurement/technical error, as well as sufficiency for detection of possible changes in secondary outcome measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRT+training | Experimental | Behavioral: Physical trainingThe 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). |
Who may qualify
- Ages
- 50 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical trainingA 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. | Behavioural | HRT+training |
Primary outcome
Short-interval intracortical inhibition (SICI)
Time frame: Change from baseline to month 2 and change from baseline to month 5
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.
18 secondary outcomes
Motor-evoked potential recruitment curve
Time frame: Change from baseline to month 2 and change from baseline to month 5
StartleTMS
Time frame: Change from baseline to month 2 and change from baseline to month 5
Intra-cortical facilitation (ICF)
Time frame: Change from baseline to month 2 and change from baseline to month 5
Long-interval intracortical inhibition (LICI)
Time frame: Change from baseline to month 2 and change from baseline to month 5
Motor-evoked potential to anterior-posterior current
Time frame: Change from baseline to month 2 and change from baseline to month 5
StartReact
Time frame: Change from baseline to month 2 and change from baseline to month 5
Maximum isometric voluntary contraction (MVC)
Time frame: Change from baseline to month 2 and change from baseline to month 5
Resting energy expenditure (i.e. resting metabolic rate)
Time frame: Change from baseline to month 2 and change from baseline to month 5
Total fat mass
Time frame: Change from baseline to month 2 and change from baseline to month 5
Fat-free mass
Time frame: Change from baseline to month 2 and change from baseline to month 5
Aotic pulse wave velocity
Time frame: Change from baseline to month 2 and change from baseline to month 5
Arterial wave reflection
Time frame: Change from baseline to month 2 and change from baseline to month 5
Reflection time
Time frame: Change from baseline to month 2 and change from baseline to month 5
Microvascular perfusion
Time frame: Change from baseline to month 2 and baseline to month 5
Endothelium-Dependent Vasodilation (Laser Doppler, %)
Time frame: Change from baseline to month 2 and change from baseline to month 5
Post-Occlusive Reactive Hyperemia (PORH, %)
Time frame: Change from baseline to month 2 and change from baseline to month 5
Resting Near-Infrared Spectroscopy (NIRS) Tissue Oxygen Saturation (StO2, %)
Time frame: Change from baseline to month 2 and change from baseline to month 5
Near-Infrared Spectroscopy (NIRS) Total Hemoglobin (tHb, au)
Time frame: Change from baseline to month 2 and change from baseline to month 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Walker, PhD principal investigator
Universirty of Jyväskylä, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Menopause and Hormone Replacement Therapy, run by University of Jyvaskyla at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Walker Dr (Dos.), PhD (+358408054906, simon.walker@jyu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-interval intracortical inhibition (SICI) (time frame: Change from baseline to month 2 and change from baseline to month 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.