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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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 that arise as part of the program. Further, participants will be provided with resistance bands, a TRX suspension trainer, and dumbbell weights in order to complete the resistance exercises for the program. Examples of how each exercise can be modified depending on a participant's limitations will also be provided as needed. The study team will ascertain whether they can progress to the next week's exercises depending on their ability to achieve the number of repetition's of the prior week.
Participants will undergo lifestyle counseling related to optimization of their nutrition and exercise regimen.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGAppendicular lean mass/height^2
Change in appendicular lean mass/height\^2 (kg/m\^2) assessed via whole body DEXA in resistance exercise group
Time frame: 12 weeks
Gender congruence
Change in gender congruence (utilizing the total scale score from Transgender Congruence Scale) in resistance exercise group
Time frame: 12 weeks
Visceral adipose tissue mass
Change in total visceral adipose tissue mass (g) assessed using whole body DEXA in resistance exercise group
Time frame: 12 weeks
Visceral adipose tissue volume
Change it total visceral adipose tissue volume (cm3) assessed using whole body DEXA in resistance exercise group
Time frame: 12 weeks
Total fat mass
Change in total fat mass (kg) assessed using whole body DEXA in resistance exercise group
Time frame: 12 weeks
Total lean body mass
Change in total lean body mass (kg) assessed using whole body DEXA in resistance exercise group
Time frame: 12 weeks
Muscular function
Change in muscular function assessed via the 5 X sit to stand test (sec) in resistance exercise group
Time frame: 12 weeks
Hand-grip strength
Change in hand-grip strength (kg) assessed using a Lafayette Hand Grip Dynamometer in resistance exercise group
Time frame: 12 weeks
Horizontal shoulder adduction strength
Change in horizontal shoulder adduction strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Time frame: 12 weeks
Shoulder extension strength
Change in shoulder extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Time frame: 12 weeks
Elbow flexion strength
Change in elbow flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Time frame: 12 weeks
Elbow extension strength
Change in elbow extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Time frame: 12 weeks
Knee extension strength
Change in knee extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Time frame: 12 weeks
Knee flexion strength
Change in knee flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Time frame: 12 weeks
Hip extension strength
Change in hip extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Time frame: 12 weeks
Resting energy expenditure
Change in resting energy expenditure (kcal/day) assessed using a metabolic cart in the resistance exercise group
Time frame: 12 weeks
Resting metabolic rate
Change in resting metabolic rate (kcal/day) assessed using a metabolic cart in resistance exercise group
Time frame: 12 weeks
Respiratory quotient
Change in respiratory quotient (ratio) assessed using a metabolic cart in the resistance exercise group
Time frame: 12 weeks
Between-group change in appendicular lean body mass/ height^2
Between-group change in appendicular lean body mass/ height\^2 (kg/m\^2) assessed via whole body DEXA
Time frame: 12 weeks
Between-group change in total visceral adipose tissue mass
Between-group change in total visceral adipose tissue mass (g) assessed using whole body DEXA
Time frame: 12 weeks
Between-group change in visceral adipose tissue volume
Between-change in total visceral adipose tissue volume (cm3) assessed using whole body DEXA
Time frame: 12 weeks
Between-group change in total fat mass
Between-change in total fat mass (kg) assessed using whole body DEXA
Time frame: 12 weeks
Between-group change in total lean body mass
Between-group change in total lean body mass (kg) assessed using whole body DEXA
Time frame: 12 weeks
Between-group change in muscular function via the 5x sit to stand test
Between-group change in muscular function assessed via the 5 X sit to stand test (sec)
Time frame: 12 weeks
Between-group change in hand-grip strength
Between-group change in hand-grip strength (kg) assessed using a Lafayette Hand Grip Dynamometer
Time frame: 12 weeks
Between-group change in horizontal shoulder adduction strength
Between-group change in horizontal shoulder adduction strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer
Time frame: 12 weeks
Bwtween-group change in shoulder extension strength
Between-group change in shoulder extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer
Time frame: 12 weeks
Between-group change in elbow flexion strength
Between-group change in elbow flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer
Time frame: 12 weeks
Between-group change in elbow extension strength
Between-group change in elbow extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer
Time frame: 12 weeks
Between-group change in knee extension strength
Between-group change in knee extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer
Time frame: 12 weeks
Between-group change in knee flexion strength
Between-group change in knee flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer
Time frame: 12 weeks
Between-group change in hip extension strength
Between-group change in hip extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer
Time frame: 12 weeks
Between-group change in resting energy expenditure
Between-group change in resting energy expenditure (kcal/day) assessed using a metabolic cart
Time frame: 12 weeks
Between-group change in resting metabolic rate
Between-group change in resting metabolic rate (kcal/day) assessed using a metabolic cart
Time frame: 12 weeks
Between-group change in respiratory quotient
Between-group change in respiratory quotient (ratio) assessed using a metabolic cart
Time frame: 12 weeks
Appearance congruence
Change in appearance congruence (utilizing the appearance congruence subscale score from Transgender Congruence Scale) in resistance exercise group
Time frame: 12 weeks
Gender identity acceptance
Change in gender identity acceptance (utilizing the gender identity acceptance subscale score from Transgender Congruence Scale) in resistance exercise group
Time frame: 12 weeks
Between-group change in appearance congruence
Between-group change in appearance congruence (utilizing the appearance congruence subscale score from Transgender Congruence Scale)
Time frame: 12 weeks
Between-group change in gender identity acceptance
Between-group change in gender identity acceptance (utilizing the gender identity acceptance subscale score from Transgender Congruence Scale)
Time frame: 12 weeks
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