Menopause Effects on Cortico-reticular Functioning
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-59
SponsorUniversity of Jyvaskyla
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Physical training
BehavioralA 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: HRT+trainingExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Change from baseline to month 2 and change from baseline to month 5Secondary outcomes
1
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.
Time frame
Change from baseline to month 2 and change from baseline to month 52
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.
Time frame
Change from baseline to month 2 and change from baseline to month 53
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.
Time frame
Change from baseline to month 2 and change from baseline to month 54
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.
Time frame
Change from baseline to month 2 and change from baseline to month 5Sponsors and contacts
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Source ClinicalTrials.gov