NCT05337865

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 17, 2022

Last Update Submit

April 14, 2022

Conditions

Transgender Persons

Keywords

Transgender womenOxygen uptakeCardiac outputMuscle strengthAcute physical effort

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Skeletal muscle mass change of transgender women over 12 months assessed by a densitometry device (GE Prodigy).

    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

    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)

    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).

    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

    Baseline, 6 months, 12 months after starting the observational study.

  • +1 more secondary outcomes

Study Arms (3)

Transgender women

Well-trained transgender women.

Other: Aerobic exercise test.

Cisgender Women

Well-trained cisgender women.

Other: Aerobic exercise test.

Cisgender Men

Well-trained cisgender men.

Other: Aerobic exercise test.

Interventions

Aerobic exercise test.OTHER

Aerobic exercise test at a treadmill.

Cisgender MenCisgender WomenTransgender women

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Well-trained Transgender women, cisgender men and cisgender women.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Leonardo Alvares, MD

CONTACT

5511963676263leo_a_alvares@yahoo.com.br

Raphael Einsfeld, Phd

CONTACT

5511987774499raphaeleinsfeld@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Technical Director

Study Record Dates

First Submitted

March 17, 2022

First Posted

April 20, 2022

Study Start

May 1, 2022

Primary Completion

August 1, 2022

Study Completion

June 1, 2023

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

No sharing will be done.