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临床试验/NCT05394935
NCT05394935已完成不适用

The Effects of High- and Moderate-Intensity Exercise on the Cerebrovascular and Cardiometabolic Health of Women with Polycystic Ovary Syndrome

Cardiff Metropolitan University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Cerebrovascular Reactivity to Carbon Dioxide (CO2)

研究概览

简要总结

This study will investigate the impact of high- and moderate-intensity exercise on the cardiometabolic and brain health of women with Polycystic Ovary syndrome (PCOS). The aim is to measure and compare normal, healthy women without PCOS, to those with the condition.

All participants will undergo a blood test. The investigators will then assess the participants cardiovascular fitness by means of a maximal exercise test and measure body composition through height, weight, and hip-to-waist ratio.

Participants will undergo an MRI, where the investigators will assess the participants brain structure and how the brain responds to a number of tests. The investigators will also conduct some tests that will assess the participants cognition, such as IQ, memory etc.

The investigators will measure the blood vessels leading to the brain and the blood flow through them to measure how much blood the brain receives when rested, using ultrasound.

The investigators will use a number of tests to look at brain function, measure the responses to these tests, and compare them between the normal, healthy women and those with PCOS. This will show if women with PCOS have a similar brain function when rested and when their brains are tested to those without the condition.

The investigators will use exercise as an intervention, where the aim will be to investigate whether women with PCOS respond similarly to those without the condition to both high-intensity and moderate-intensity exercise. The tests of brain function will be repeated following the exercise, and see if both normal, healthy women and those with PCOS have a similar response to the brain function tests.

All tests and measures will be compared between the PCOS group, and the healthy control group to establish any potential differences or similarities as a result of the condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

All participant data and exercise arm will be anonymised and non-identifiable by the assessor.

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Polycystic Ovary Syndrome as diagnosed by any recognised criteria.
  • Inactive (less than 40 mins of structured exercise per week).

排除标准

  • Pregnant or breastfeeding.
  • Congenital adrenal hyperplasia, Cushing's syndrome, thyroid disease, hyperprolactinaemia and androgen secreting tumours.
  • Known history of cardiovascular disease.
  • Contraindications to MRI (fitted with ferromagnetic devices).

结局指标

主要结局

Cerebrovascular Reactivity to Carbon Dioxide (CO2)

时间窗: Less than 1 hour post-exercise

6% CO2 administered to measure reactivity of the cerebrovasculature as measured by extra-cranial ultrasonography.

Cerebral blood velocity in the middle (MCAv) and posterior cerebral arteries (PCAv) during exercise

时间窗: During moderate-intensity exercise (50 minutes)

MCAv and PCAv will be assessed using transcranial Doppler and employed throughout both bouts of acute exercise.

Neurovascular coupling (NVC)

时间窗: Less than 1 hour post-exercise

NVC will be assessed using a visual task (flashing checkerboard) measured via transcranial Doppler.

Dynamic cerebral autoregulation (dCA)

时间窗: Less than 1 hour post-exercise

dCA will be assessed using a squat-stand method to induce forced oscillations in blood pressure and measured using finger plethysmography and transcranial Doppler.

次要结局

  • Cerebral structure(Baseline)
  • Cardiorespiratory fitness (CRF)(Baseline)
  • Hormone profile(Baseline)
  • Cerebrovascular reactivity(Baseline)
  • Cerebral metabolic rate of oxygen consumption(Baseline)
  • Cognitive testing(Baseline)
  • Cerebral blood flow(Baseline)
  • Blood pressure during exercise(During High-intensity interval exercise (HIIT) (24 minutes) and Moderate-intensity steady state (MISS) (50 minutes) exercise)
  • Metabolic profile(Baseline)
  • Lipid profile(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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