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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06116201
Enrollment
60
Registered
2023-11-03
Start date
2020-08-15
Completion date
2021-07-31
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transgender Women

Keywords

Transgender women, Physical fitness, Vascular function, Hormone therapy

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.

Interventions

OTHEREstradiol

Estradiol

OTHEREstradiol and Anti-Androgen

Estradiol and Anti-Androgen

OTHERNo intervention

No intervention

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

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).

Exclusion criteria

* Participants had an injury during testing.

Design outcomes

Primary

MeasureTime frameDescription
Anaerobic fitnessBaselineAnaerobic fitness will be measured by Wingate test protocol with ergocycle (Monark 894e).
Muscular powerBaselineMuscular power will be measured by vertical jump with force plate detected machine (Ballistic Measurement System & FT 700 Power Cage, Fitness Technology).
SpeedBaselineSpeed will be measured by sprint test for 40 meters with timing gate device (SpeedLight Timing System, Swiftperformance).
Resting metabolic rateBaselineEnergy expenditure will be measured by canopy study protocol with stationary gas analyzer (VMAX, Encore 29 system).
Heart rateBaselineHeart rate will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).
Blood pressureBaselineSystolic 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.
Body weightBaselineBody weight and height will be measured with automated body composition machine (ioi 353, Jawon medical).
HeightBaselineHeight will be measured with automated body composition machine (ioi 353, Jawon medical).
Vascular structureBaselineIntima-Media Thickness will be measured with ultrasonography equipment on carotid artery (EPIQ 5G, Phillips).
Macro vascular functionBaselineMacro vascular function will be measured by brachial artery flow-mediated dilatation protocol on brachial artery with ultrasonography equipment (EPIQ 5G, Phillips).
Arterial stiffnessBaselineArterial stiffness will be measured with brachial-ankle pulse wave velocity (VP-1000 plus, omrom Healthcare).
Micro vascular functionBaselineMicro 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 massBaselineMuscle mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
Fat massBaselineFat mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
Bone mineral contentBaselineBone mineral content will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
Bone mineral densityBaselineBone mineral density will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).
T-score of bone densityBaselineT-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.
Cardiorespiratory fitnessBaselineMaximal oxygen consumption will be measured by Bruce protocol for treadmill test with stationary gas analyzer (VMAX, Encore 29 system).
FlexibilityBaselineSit and reach test will be measured by sit and reach protocol with sit and reach box (Grandsport).
Muscle strength and muscle enduranceBaselineMuscle strength and muscle endurance will be measured by concentric/concentric protocol with isokinetic machine (Biodex Multi-Joint System-Pro, Biodex).
AgilityBaselineAgility will be measured by T-test protocol with timing gate device (SpeedLight Timing System, Swiftperformance).
BalanceBaselineBalance will be measured by balance error scoring system (BESS) protocol with postural sway detected machine (Biosway, Biodex).
Coordination and reaction timeBaselineCoordination and reaction time will be measured by eye-hand coordination protocol with light reacted device (FITLIGHT Trainer).

Secondary

MeasureTime frameDescription
Stress levelBaselineStress 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 levelBaselineQuality 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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026