Transgender PersonsTOPNCT05337865
Transgender Observational Performance
An observational study of Transgender Persons, run by Instituto Brasileiro de Controle do Cancer.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Transgender Persons
- What is being tested?
- Aerobic exercise test.
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Well-trained Transgender women, cisgender men and cisgender women.
Who may be able to join
- 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)
Who cannot join
- Current or previous morbidities that could interfere with strength or aerobic tests.
- Chronic illnesses and/or chronic medication use.
- Musculoskeletal limitations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of the Aerobic Capacity of (Well-trained) Transgender Women Athletes Submitted to the Maximal Exercise Test: a Prospective Cohort.
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.
- Conditions
- Transgender Persons
- Being tested
- Aerobic exercise test.
- Keywords
- Transgender women, Oxygen uptake, Cardiac output, Muscle strength, Acute physical effort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise test.Other
Aerobic exercise test at a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Transgender women | Well-trained transgender women. Receives: Other: Aerobic exercise test. | |
| Cisgender Women | Well-trained cisgender women. Receives: Other: Aerobic exercise test. | |
| Cisgender Men | Well-trained cisgender men. Receives: Other: Aerobic exercise test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, 12 months after starting the observational study.
Secondary outcomes (6)
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.
Measured: Baseline, 6 months, 12 months after starting the observational study.
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.
Measured: Baseline, 6 months, 12 months after starting the observational study.
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.
Measured: Baseline, 6 months, 12 months after starting the observational study.
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.
Measured: Baseline, 6 months, 12 months after starting the observational study.
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®).
Measured: Baseline, 6 months, 12 months after starting the observational study.
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.
Measured: Baseline, 6 months, 12 months after starting the observational study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Brasileiro de Controle do Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Alvares, Instituto Brasileiro de Controle do Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337865
- Sponsor's protocol ID
- 52428321.2.0000.0062
- Acronym
- TOP
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing will be done.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Aerobic Capacity of (Well-trained) Transgender Women Athletes Submitted to the Maximal Exercise Test: a Prospective Cohort.
- ClinicalTrials.gov ID
- NCT05337865
- Acronym / sponsor ID
- TOP / 52428321.2.0000.0062
- Conditions
- Transgender Persons
- Keywords
- Transgender women, Oxygen uptake, Cardiac output, Muscle strength, Acute physical effort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Brasileiro de Controle do CancerUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transgender women | – | Other: Aerobic exercise test.Well-trained transgender women. |
| Cisgender Women | – | Other: Aerobic exercise test.Well-trained cisgender women. |
| Cisgender Men | – | Other: Aerobic exercise test.Well-trained cisgender men. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Well-trained Transgender women, cisgender men and cisgender women.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Current or previous morbidities that could interfere with strength or aerobic tests.
- Chronic illnesses and/or chronic medication use.
- Musculoskeletal limitations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise test.Aerobic exercise test at a treadmill. | Other | Cisgender Men, Cisgender Women, Transgender women |
Primary outcome
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).
Time frame: Baseline, 6 months, 12 months after starting the observational study.
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.
6 secondary outcomes
Skeletal muscle mass change of transgender women over 12 months assessed by a densitometry device (GE Prodigy).
Time frame: Baseline, 6 months, 12 months after starting the observational study.
Muscle strength change of transgender women over 12 months assessed by hand grip strength (HGS) test using the Jamar Hand Dynamometer
Time frame: Baseline, 6 months, 12 months after starting the observational study.
Vertical jump height changes of transgender women over 12 months assessed by the jumping mat (Elite Jump®, S2 Sports, São Paulo, Brazil)
Time frame: Baseline, 6 months, 12 months after starting the observational study.
Speed changes of transgender women over 12 months assessed by 20-meter run with change of direction (Zig-Zag Test).
Time frame: Baseline, 6 months, 12 months after starting the observational study.
Heart rate change of transgender women over 12 months assessed by frequency meter (Polar®) during cardiopulmonary exercise testing
Time frame: Baseline, 6 months, 12 months after starting the observational study.
Percentage of body fat mass (%FM) change of transgender women over 12 months assessed by a densitometry device (GE Prodigy).
Time frame: Baseline, 6 months, 12 months after starting the observational study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No. No sharing will be done.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender Persons, run by Instituto Brasileiro de Controle do Cancer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo Alvares, MD (5511963676263, leo_a_alvares@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Baseline, 6 months, 12 months after starting the observational study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.