Transgender Observational Performance

Transgender Persons Clinical Trial

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Official title:

Assessment of the Aerobic Capacity of (Well-trained) Transgender Women Athletes Submitted to the Maximal Exercise Test: a Prospective Cohort.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05337865
• Other study ID #: 52428321.2.0000.0062
• Status: Not yet recruiting
• Start date: May 2022
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: Leonardo Alvares, MD
• Phone: 5511963676263
• Email: leo_a_alvares[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transgender Persons

Intervention

Other:
• Aerobic exercise test.
Aerobic exercise test at a treadmill.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	The comparison of changes in aerobic capacity of transgender women, cigender women and cisgender men submitted to maximum effort Participants will be submitted to cardiopulmonary exercise testing (K5 - COSMED, Italia) on a treadmill (MOVEMENT/ET20 RT250G2SAC110V ) with incremental effort until exhaustion (ramp protocol). The maximum functional capacity will be determined by peak oxygen consumption (VO2peak) evaluated at the maximum exercise intensity.	Baseline, 6 months, 12 months after starting the observational study.
Secondary	Skeletal muscle mass change of transgender women over 12 months assessed by a densitometry device (GE Prodigy).	The comparison of changes in skeletal muscle mass (kg) of transgender women, cisgender women and cisgender men over 12 months. Muscle mass will be assessed by a densitometry device (GE Prodigy) with X-ray absorptiometry technique with two whole-body energy levels and analyzed in the corresponding manufacturer's software.	Baseline, 6 months, 12 months after starting the observational study.
Secondary	Muscle strength change of transgender women over 12 months assessed by hand grip strength (HGS) test using the Jamar Hand Dynamometer	The comparison of changes in muscle strength of transgender women, cisgender women and cisgender men over 12 months. The hand grip strength (HGS) test will be carried out using the Jamar Hand Dynamometer by technique recommended by the American Society of Hand Therapists (ASHT) The tests will be performed with the dominant and non-dominant hands of each individual three consecutive times. Participants will be instructed to perform a maximum contraction for 3 seconds in each test. There will be a 30-second rest period between each test. To analyse the parameters associated with the measurement of HGS in each individual, the mean values (kg) of the three tests for each hand will be used according to the ASHT reference and considered the most reliable way to measure HGS. The maximum strength (kg) of each individual will be also analysed.	Baseline, 6 months, 12 months after starting the observational study.
Secondary	Vertical jump height changes of transgender women over 12 months assessed by the jumping mat (Elite Jump®, S2 Sports, São Paulo, Brazil)	The comparison of changes in vertical jump during sprint of transgender women, cisgender women and cisgender men over 12 months.Vertical jump heights (cm) will be evaluated using two different techniques - the jump with a static start at 90° of knee flexion for ~2s before the jump, and another free jump to make the descent movement and vertical impulse with leg extension. The depth of the countermovement will be determined by the participant himself, in order to avoid alterations in the coordination of the jump.; All jumps must be performed with hands on hips and participants will be instructed to jump as high as possible.; The jumping mat (Elite Jump®, S2 Sports, São Paulo, Brazil) will be used. A total of five attempts will be allowed for each jump, spaced by 15 second intervals. The highest height for each modality will be used for future analyses.	Baseline, 6 months, 12 months after starting the observational study.
Secondary	Speed changes of transgender women over 12 months assessed by 20-meter run with change of direction (Zig-Zag Test).	The comparison of changes of speed during sprint of transgender women, cisgender women and cisgender men over 12 months.Participants will be instructed to fast for at least 2 hours before the test, following the dietary recommendations described for the maximal effort test. Before the start of the tests, participants will be asked to perform a warm-up protocol including running for 10 minutes of light to moderate intensity, followed by 3 minutes of active lower limb stretching.; We will use the 20-meter run with change of direction (Zig-Zag Test). There will be 3 changes of direction with cones at 100° of angulation. The average duration of execution of this test by trained individuals ranges between 5 and 6 seconds.; Photocells will be used to start and stop the timer, in order to increase the accuracy of the test.; Participants will take the test in 3 attempts, with a 15-minute break between them, for equipment adjustments and rest.	Baseline, 6 months, 12 months after starting the observational study.
Secondary	Heart rate change of transgender women over 12 months assessed by frequency meter (Polar®) during cardiopulmonary exercise testing	The comparison of changes in heart rate capacity of transgender women, cigender women and cisgender men submitted to maximum effort Participants will be submitted to cardiopulmonary exercise testing (K5 - COSMED, Italia) on a treadmill (MOVEMENT/ET20 RT250G2SAC110V ) with incremental effort until exhaustion (ramp protocol. Heart rate will be continuously evaluated through frequency meter (Polar®).	Baseline, 6 months, 12 months after starting the observational study.
Secondary	Percentage of body fat mass (%FM) change of transgender women over 12 months assessed by a densitometry device (GE Prodigy).	The comparison of changes in percentage of body fat mass (%FM), of transgender women, cisgender women and cisgender men over 12 months. Muscle mass will be assessed by a densitometry device (GE Prodigy) with X-ray absorptiometry technique with two whole-body energy levels and analyzed in the corresponding manufacturer's software.	Baseline, 6 months, 12 months after starting the observational study.