Clinical trial NCT05337865: Transgender Observational Performance
Official title: Assessment of the Aerobic Capacity of (Well-trained) Transgender Women Athletes Submitted to the Maximal Exercise Test: a Prospective Cohort.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transgender Persons
Keywords: Transgender women
Oxygen uptake
Cardiac output
Muscle strength
Acute physical effort
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Well-trained Transgender women, cisgender men and cisgender women.

Brief summary: The study will evaluate the sports capabilities of transgender women mainly in terms of muscular strength and aerobic capacity (VO2max). The control group will be composed of cisgender women and cisgender men with the same levels of physical activity.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a transgender woman by the DSM-V or ICD10.
* Gonadectomized and non-gonadectomized
* Initiation of androgen blockade and/or estrogen use after 12 years of age.
* Age range 18 to 50 years old.
* BMI: 18.0 to 34.9 kg/m2.
* Well-trained individuals (IPAQ very active)

Exclusion Criteria:

* Current or previous morbidities that could interfere with strength or aerobic tests.
* Chronic illnesses and/or chronic medication use.
* Musculoskeletal limitations.

Primary outcomes:
measure: Aerobic capacity change of transgender women over 12 months assessed by cardiopulmonary exercise testing (K5 - COSMED, Italia) on a treadmill (MOVEMENT/ET20 RT250G2SAC110V ) with incremental effort until exhaustion (ramp protocol).
timeFrame: Baseline, 6 months, 12 months after starting the observational study.
Secondary outcomes:
measure: Skeletal muscle mass change of transgender women over 12 months assessed by a densitometry device (GE Prodigy).
timeFrame: Baseline, 6 months, 12 months after starting the observational study.
measure: Muscle strength change of transgender women over 12 months assessed by hand grip strength (HGS) test using the Jamar Hand Dynamometer
timeFrame: Baseline, 6 months, 12 months after starting the observational study.
measure: Vertical jump height changes of transgender women over 12 months assessed by the jumping mat (Elite Jump®, S2 Sports, São Paulo, Brazil)
timeFrame: Baseline, 6 months, 12 months after starting the observational study.
measure: Speed changes of transgender women over 12 months assessed by 20-meter run with change of direction (Zig-Zag Test).
timeFrame: Baseline, 6 months, 12 months after starting the observational study.
measure: Heart rate change of transgender women over 12 months assessed by frequency meter (Polar®) during cardiopulmonary exercise testing
timeFrame: Baseline, 6 months, 12 months after starting the observational study.
measure: Percentage of body fat mass (%FM) change of transgender women over 12 months assessed by a densitometry device (GE Prodigy).
timeFrame: Baseline, 6 months, 12 months after starting the observational study.
Other outcomes:
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