Female Sex Hormone and Menopause Effects on Cortico-reticular Functioning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Short-interval intracortical inhibition (SICI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Exclusion Criteria:
- •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
- •diagnosed psychiatric illness
- •other diagnosed injuries/illness affecting the neuromuscular system
研究组 & 干预措施
HRT+training
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).
干预措施: Physical training (Behavioral)
结局指标
主要结局
Short-interval intracortical inhibition (SICI)
时间窗: 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.
次要结局
- Motor-evoked potential recruitment curve(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)
- StartReact(Change from baseline to month 2 and change from baseline to month 5)
- Maximum isometric voluntary contraction (MVC)(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)
- Resting energy expenditure (i.e. resting metabolic rate)(Change from baseline to month 2 and change from baseline to month 5)
- Total fat mass(Change from baseline to month 2 and change from baseline to month 5)
- Fat-free mass(Change from baseline to month 2 and change from baseline to month 5)
- Aotic pulse wave velocity(Change from baseline to month 2 and change from baseline to month 5)
- Arterial wave reflection(Change from baseline to month 2 and change from baseline to month 5)
- Reflection time(Change from baseline to month 2 and change from baseline to month 5)
- Microvascular perfusion(Change from baseline to month 2 and baseline to month 5)
- Endothelium-Dependent Vasodilation (Laser Doppler, %)(Change from baseline to month 2 and change from baseline to month 5)
- Post-Occlusive Reactive Hyperemia (PORH, %)(Change from baseline to month 2 and change from baseline to month 5)
- Resting Near-Infrared Spectroscopy (NIRS) Tissue Oxygen Saturation (StO2, %)(Change from baseline to month 2 and change from baseline to month 5)
- Near-Infrared Spectroscopy (NIRS) Total Hemoglobin (tHb, au)(Change from baseline to month 2 and change from baseline to month 5)
研究者
Simon Walker
Dr (Dos.)
University of Jyvaskyla