Skip to main content
OpenTrials
Completed

NCT Number: NCT06116201

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Participants had an injury during testing.

Treatment and study plan

Estradiol

Other

Estradiol

Estradiol and Anti-Androgen

Other

Estradiol and Anti-Androgen

No intervention

Other

No intervention

Primary outcomes

  1. Heart rate

    Time frame: Baseline

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

  2. Blood pressure

    Time frame: 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.

  3. Body weight

    Time frame: Baseline

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

  4. Height

    Time frame: Baseline

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

  5. Resting metabolic rate

    Time frame: Baseline

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

  6. Vascular structure

    Time frame: Baseline

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

  7. Macro vascular function

    Time frame: Baseline

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

  8. Arterial stiffness

    Time frame: Baseline

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

  9. Micro vascular function

    Time frame: 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).

  10. Muscle mass

    Time frame: Baseline

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

  11. Fat mass

    Time frame: Baseline

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

  12. Bone mineral content

    Time frame: Baseline

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

  13. Bone mineral density

    Time frame: Baseline

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

  14. T-score of bone density

    Time frame: 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.

  15. Cardiorespiratory fitness

    Time frame: Baseline

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

  16. Muscle strength and muscle endurance

    Time frame: Baseline

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

  17. Flexibility

    Time frame: Baseline

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

  18. Agility

    Time frame: Baseline

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

  19. Balance

    Time frame: Baseline

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

  20. Coordination and reaction time

    Time frame: Baseline

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

  21. Muscular power

    Time frame: Baseline

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

  22. Speed

    Time frame: Baseline

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

  23. Anaerobic fitness

    Time frame: Baseline

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

Secondary outcomes

  1. Quality of life level

    Time frame: 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.

  2. Stress level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 3, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.