Effects of Resistance Exercise Among TGD Individuals Initiating Estrogen-Based Gender-Affirming Hormone Therapy

Обзор

Estrogen-dominant gender-affirming hormone therapy (GAHT) is standard of care for transgender women and gender-diverse individuals and typically consists of estrogen together with anti-androgen/ testosterone therapy. Estrogen and testosterone balance influences fat and muscle mass, muscular strength and the development of sarcopenia. Sarcopenia, a condition characterized by the loss of muscular mass, strength, and function, in turn, is associated with increased mortality and adverse health outcomes. Estrogen-dominant GAHT may have deleterious effects on body composition and muscular performance that place TGD individuals at-risk for sarcopenia. As part of NCT04128488, our investigative team found that appendicular lean mass (ALM)/ height2 decreases after estrogen-based GAHT, thereby portending a higher risk for sarcopenia after GAHT. Early recognition of the changes in body composition and muscular performance leading to sarcopenia are critical, providing potential avenues to intervene and abrogate untoward downstream health effects. A promising intervention is resistance exercise, which has been shown in select populations to improve muscular mass and strength and reduce fat mass, and, thus, mitigate progression to sarcopenia in at-risk populations. For this prospective, pilot clinical trial, investigators will enroll participants who are about to be initiated on estrogen-dominant gender-affirming hormone therapy. Investigators will be randomizing participants 1:1 to either an at-home resistance exercise intervention or no exercise intervention (nutritional and exercise counseling only) for 12 weeks and assess muscle mass, strength, and function both before and after this 12-week period. The exercise intervention group will be provided with the necessary materials to complete the exercise program along with weekly virtual visits with our study team in order to learn their assigned exercises for the week. Further, survey tools will be administered to ascertain whether the resistance exercise intervention may affect gender congruence.

Вмешательства

• Поведенческое Resistance Exercise Program
  Participants will initiate this program at the time that they start their gender-affirming hormone therapy and will be instructed to complete resistance exercises for three 60-minute sessions per week for 12 weeks. Participants will have a weekly video call to demonstrate the exercises for that week, have a supervised training session to ensure exercises are performed safely and as instructed, monitor their continued participation in the exercise intervention, and answer any questions or issues
• Поведенческое Nutrition and Exercise Counseling
  Participants will undergo lifestyle counseling related to optimization of their nutrition and exercise regimen.

Первичные конечные точки

• Appendicular lean mass/height^2 [Срок оценки: 12 weeks]
• Gender congruence [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

• Visceral adipose tissue mass [Срок оценки: 12 weeks]
• Visceral adipose tissue volume [Срок оценки: 12 weeks]
• Total fat mass [Срок оценки: 12 weeks]
• Total lean body mass [Срок оценки: 12 weeks]
• Muscular function [Срок оценки: 12 weeks]
• Hand-grip strength [Срок оценки: 12 weeks]
• Horizontal shoulder adduction strength [Срок оценки: 12 weeks]
• Shoulder extension strength [Срок оценки: 12 weeks]
• Elbow flexion strength [Срок оценки: 12 weeks]
• Elbow extension strength [Срок оценки: 12 weeks]
• Knee extension strength [Срок оценки: 12 weeks]
• Knee flexion strength [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• ≥ 18 years
• Initiating GAHT with estradiol (oral, sublingual, patch, injection) AND androgen suppression (leuprolide, spironolactone or bicalutamide)
• Identifies as either a transgender female/woman, gender-diverse, non-binary, gender non-confirming, gender-fluid, and/or gender-queer
• Assigned male sex at birth

Критерии исключения

• Current condition(s) which may preclude the ability to participate in a resistance exercise program (including but not limited to conditions which may significantly impair mobility and balance)
• Current condition(s) where resistance exercise program may be contraindicated (including but not limited to decompensated heart failure, unstable ischemic heart disease, pulmonary hypertension, aortic aneurysm, moderate to severe valvopathies, and/or moderate to severe chronic respiratory insufficiency)
• Use of testosterone therapy for > 1 month in the last 6 months
• Use of gender-affirming hormone therapy with androgen/testosterone suppression and/or estradiol therapy within 1 year of enrollment
• Use of gender-affirming hormone therapy with androgen/testosterone suppression and/or estradiol therapy for > 1 year at any time period prior to enrollment
• History of an orchiectomy
• Current resistance exercise (including but not limited to use of resistance bands, suspension equipment, body weight exercise, free weight exercise) of 60 minutes or greater per week
• Enrollment in another study that the study investigators deem as potentially interfering with study participants or study endpoints

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07400419 · 2025P003023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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