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

Not Applicable

Completed

• Conditions: Transgender Women
• Interventions: Other: No intervention; Other: Estradiol; Other: Estradiol and Anti-Androgen

• Registration Number: NCT06116201
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2020-08-15
• Study First Submitted: 2021-05-27
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-31
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-03
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Cisgender men group (Body mass index between 18.5-24.9 and NO NCDs).
2. Cisgender women group (Body mass index between 18.5-24.9, No pregnant, NO NCDs).
3. Transgender women with orchiectomy (Body mass index between 18.5-24.9, taking estradiol, testosterone level below 10 nmol/L, NO NCDs).
4. 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).

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Exclusion Criteria

• Participants had an injury during testing.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisgender women	No intervention	Cisgender women who lived in normal life were not used medication process for sex transition. They were recruited for measurement of all variables in the study to compare with another group.
Transgender women with orchiectomy	Estradiol	Transgender women who took medication for sex transition form male to female via estradiol hormone therapy and orchiectomy surgery. They were recruited for measurement of all variables in the study to compare with another group.
Cisgender men	No intervention	Cisgender men who lived in normal life were not used medication process for sex transition. They were recruited for measurement of all variables in the study to compare with another group.
Transgender women without orchiectomy	Estradiol and Anti-Androgen	Transgender women who took medication for sex transition form male to female via estradiol hormone and anti-androgen hormone therapy. They were recruited for measurement of all variables in the study to compare with another group.

Primary Outcome Measures

Name	Time	Method
Agility	Baseline	Agility will be measured by T-test protocol with timing gate device (SpeedLight Timing System, Swiftperformance).
Height	Baseline	Height will be measured with automated body composition machine (ioi 353, Jawon medical).
Bone mineral density	Baseline	Bone mineral density will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
T-score of bone density	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	Baseline	Sit and reach test will be measured by sit and reach protocol with sit and reach box (Grandsport).
Heart rate	Baseline	Heart rate will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
Blood pressure	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.
Muscular power	Baseline	Muscular power will be measured by vertical jump with force plate detected machine (Ballistic Measurement System \& FT 700 Power Cage, Fitness Technology).
Speed	Baseline	Speed will be measured by sprint test for 40 meters with timing gate device (SpeedLight Timing System, Swiftperformance).
Body weight	Baseline	Body weight and height will be measured with automated body composition machine (ioi 353, Jawon medical).
Macro vascular function	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	Baseline	Arterial stiffness will be measured with brachial-ankle pulse wave velocity (VP-1000 plus, omrom Healthcare).
Micro vascular function	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	Baseline	Muscle mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
Resting metabolic rate	Baseline	Energy expenditure will be measured by canopy study protocol with stationary gas analyzer (VMAX, Encore 29 system).
Vascular structure	Baseline	Intima-Media Thickness will be measured with ultrasonography equipment on carotid artery (EPIQ 5G, Phillips).
Muscle strength and muscle endurance	Baseline	Muscle strength and muscle endurance will be measured by concentric/concentric protocol with isokinetic machine (Biodex Multi-Joint System-Pro, Biodex).
Balance	Baseline	Balance will be measured by balance error scoring system (BESS) protocol with postural sway detected machine (Biosway, Biodex).
Anaerobic fitness	Baseline	Anaerobic fitness will be measured by Wingate test protocol with ergocycle (Monark 894e).
Fat mass	Baseline	Fat mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
Bone mineral content	Baseline	Bone mineral content will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
Cardiorespiratory fitness	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	Baseline	Coordination and reaction time will be measured by eye-hand coordination protocol with light reacted device (FITLIGHT Trainer).

Secondary Outcome Measures

Name	Time	Method
Stress level	Baseline	Stress level will be measured by Suanprung Stress Test-20 questionnaire. The scores of questionnaire were 100 points for maximum value and 20 points for minimum value. 4 levels in stress less than 24 points for low stress range, 24-41 points for normal stress range, 42-61 points for high stress range, and more than 61 points for severe stress range.
Quality of life level	Baseline	Quality of life will level will be measured by World Health Organization Quality of Life Brief - Thai questionnaire. The scores of questionnaire were 130 points for maximum value and 26 points for minimum value. 3 levels in quality of life were less than 61 points for below normal range, 61-95 points for normal range, and more than 95 points for above normal range.

Trial Locations

Locations (1)

Faculty of Sports Science, Chulalongkorn University; 🇹🇭 Pathum Wan, Bangkok, Thailand