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临床试验/NCT05337865
NCT05337865Unknown不适用

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

Instituto Brasileiro de Controle do Cancer0 个研究点目标入组 60 人开始时间: 2022年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
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).

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of a transgender woman by the DSM-V or ICD
  • 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/m
  • Well-trained individuals (IPAQ very active)

排除标准

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

结局指标

主要结局

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).

时间窗: 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.

次要结局

  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • Percentage of body fat mass (%FM) change of transgender women over 12 months assessed by a densitometry device (GE Prodigy).(Baseline, 6 months, 12 months after starting the observational study.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Alvares

Medical Technical Director

Instituto Brasileiro de Controle do Cancer

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