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临床试验/NCT06116201
NCT06116201已完成不适用

Influences of Long Term Hormone Therapy on Physical Fitness and Vascular Function in Transgender Women

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月15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
60
试验地点
2
主要终点
Agility

研究概览

简要总结

Transgender women who transitioned from male to female by hormone therapy demonstrate similar physical fitness and vascular function to males or females.

详细描述

This cross-sectional study was to compare physical fitness and vascular function between cisgender men, cisgender women, and transgender women.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Cisgender men group (Body mass index between 18.5-24.9 and NO NCDs).
  • Cisgender women group (Body mass index between 18.5-24.9, No pregnant, NO NCDs).
  • Transgender women with orchiectomy (Body mass index between 18.5-24.9, taking estradiol, testosterone level below 10 nmol/L, NO NCDs).
  • Transgender women without orchiectomy (Body mass index between 18.5-24.9, taking estradiol and anti-androgen, testosterone level below 10 nmol/L, NO NCDs).

排除标准

  • Participants had an injury during testing.

结局指标

主要结局

Agility

时间窗: Baseline

Agility will be measured by T-test protocol with timing gate device (SpeedLight Timing System, Swiftperformance).

Height

时间窗: Baseline

Height will be measured with automated body composition machine (ioi 353, Jawon medical).

Bone mineral density

时间窗: Baseline

Bone mineral density will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

T-score of bone density

时间窗: Baseline

T-score will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare). T-score was separated into 3 categories, 1 or higher of T-score that is the healthy bone, -1 to -2.5 of T-score that is osteopenia, and -2.5 or lower that is osteoporosis.

Flexibility

时间窗: Baseline

Sit and reach test will be measured by sit and reach protocol with sit and reach box (Grandsport).

Body weight

时间窗: Baseline

Body weight and height will be measured with automated body composition machine (ioi 353, Jawon medical).

Heart rate

时间窗: Baseline

Heart rate will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).

Blood pressure

时间窗: Baseline

Systolic blood pressure and diastolic blood pressure will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap). Mean arterial blood pressure was calculated from systolic blood pressure and diastolic blood pressure via mean arterial pressure formula.

Macro vascular function

时间窗: Baseline

Macro vascular function will be measured by brachial artery flow-mediated dilatation protocol on brachial artery with ultrasonography equipment (EPIQ 5G, Phillips).

Arterial stiffness

时间窗: Baseline

Arterial stiffness will be measured with brachial-ankle pulse wave velocity (VP-1000 plus, omrom Healthcare).

Micro vascular function

时间窗: Baseline

Micro vascular function will be measured by post-occlusive hyperemia protocol of fingertip cutaneous blood flow with laser doppler flowmetry device (PeriFlux system 5000, Perimed).

Muscle mass

时间窗: Baseline

Muscle mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

Muscular power

时间窗: Baseline

Muscular power will be measured by vertical jump with force plate detected machine (Ballistic Measurement System \& FT 700 Power Cage, Fitness Technology).

Speed

时间窗: Baseline

Speed will be measured by sprint test for 40 meters with timing gate device (SpeedLight Timing System, Swiftperformance).

Resting metabolic rate

时间窗: Baseline

Energy expenditure will be measured by canopy study protocol with stationary gas analyzer (VMAX, Encore 29 system).

Vascular structure

时间窗: Baseline

Intima-Media Thickness will be measured with ultrasonography equipment on carotid artery (EPIQ 5G, Phillips).

Muscle strength and muscle endurance

时间窗: Baseline

Muscle strength and muscle endurance will be measured by concentric/concentric protocol with isokinetic machine (Biodex Multi-Joint System-Pro, Biodex).

Balance

时间窗: Baseline

Balance will be measured by balance error scoring system (BESS) protocol with postural sway detected machine (Biosway, Biodex).

Anaerobic fitness

时间窗: Baseline

Anaerobic fitness will be measured by Wingate test protocol with ergocycle (Monark 894e).

Fat mass

时间窗: Baseline

Fat mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

Bone mineral content

时间窗: Baseline

Bone mineral content will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

Cardiorespiratory fitness

时间窗: Baseline

Maximal oxygen consumption will be measured by Bruce protocol for treadmill test with stationary gas analyzer (VMAX, Encore 29 system).

Coordination and reaction time

时间窗: Baseline

Coordination and reaction time will be measured by eye-hand coordination protocol with light reacted device (FITLIGHT Trainer).

次要结局

  • Stress level(Baseline)
  • Quality of life level(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr.Daroonwan Suksom

Faculty of Sports Science

Chulalongkorn University

研究点 (2)

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