Muscle Mass and Strength
Conditions
Keywords
Transgender women, Gender-Diverse, Estrogen-dominant gender-affirming hormone therapy, Sarcopenia
Brief summary
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 or recently initiated (3 months ago or less) 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.
Interventions
BEHAVIORALResistance Exercise Program
Participants will initiate this program within approximately 3 months of starting 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 intervention, and address any questions/issues that arise as part of the program. 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.
BEHAVIORALNutrition and Exercise Counseling
Participants will undergo lifestyle counseling related to optimization of their nutrition and exercise regimen.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years * Initiating or within 3 months or less of 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appendicular lean mass/height^2 | 12 weeks | Change in appendicular lean mass/height\^2 (kg/m\^2) assessed via whole body DEXA in resistance exercise group |
| Gender congruence | 12 weeks | Change in gender congruence (utilizing the total scale score from Transgender Congruence Scale) in resistance exercise group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visceral adipose tissue mass | 12 weeks | Change in total visceral adipose tissue mass (g) assessed using whole body DEXA in resistance exercise group |
| Visceral adipose tissue volume | 12 weeks | Change it total visceral adipose tissue volume (cm3) assessed using whole body DEXA in resistance exercise group |
| Total fat mass | 12 weeks | Change in total fat mass (kg) assessed using whole body DEXA in resistance exercise group |
| Total lean body mass | 12 weeks | Change in total lean body mass (kg) assessed using whole body DEXA in resistance exercise group |
| Muscular function | 12 weeks | Change in muscular function assessed via the 5 X sit to stand test (sec) in resistance exercise group |
| Hand-grip strength | 12 weeks | Change in hand-grip strength (kg) assessed using a Lafayette Hand Grip Dynamometer in resistance exercise group |
| Horizontal shoulder adduction strength | 12 weeks | Change in horizontal shoulder adduction strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group |
| Shoulder extension strength | 12 weeks | Change in shoulder extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group |
| Elbow flexion strength | 12 weeks | Change in elbow flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group |
| Elbow extension strength | 12 weeks | Change in elbow extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group |
| Knee extension strength | 12 weeks | Change in knee extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group |
| Knee flexion strength | 12 weeks | Change in knee flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group |
| Hip extension strength | 12 weeks | Change in hip extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group |
| Resting energy expenditure | 12 weeks | Change in resting energy expenditure (kcal/day) assessed using a metabolic cart in the resistance exercise group |
| Resting metabolic rate | 12 weeks | Change in resting metabolic rate (kcal/day) assessed using a metabolic cart in resistance exercise group |
| Respiratory quotient | 12 weeks | Change in respiratory quotient (ratio) assessed using a metabolic cart in the resistance exercise group |
| Between-group change in appendicular lean body mass/ height^2 | 12 weeks | Between-group change in appendicular lean body mass/ height\^2 (kg/m\^2) assessed via whole body DEXA |
| Between-group change in total visceral adipose tissue mass | 12 weeks | Between-group change in total visceral adipose tissue mass (g) assessed using whole body DEXA |
| Between-group change in visceral adipose tissue volume | 12 weeks | Between-change in total visceral adipose tissue volume (cm3) assessed using whole body DEXA |
| Between-group change in total fat mass | 12 weeks | Between-change in total fat mass (kg) assessed using whole body DEXA |
| Between-group change in total lean body mass | 12 weeks | Between-group change in total lean body mass (kg) assessed using whole body DEXA |
| Between-group change in muscular function via the 5x sit to stand test | 12 weeks | Between-group change in muscular function assessed via the 5 X sit to stand test (sec) |
| Between-group change in hand-grip strength | 12 weeks | Between-group change in hand-grip strength (kg) assessed using a Lafayette Hand Grip Dynamometer |
| Between-group change in horizontal shoulder adduction strength | 12 weeks | Between-group change in horizontal shoulder adduction strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer |
| Bwtween-group change in shoulder extension strength | 12 weeks | Between-group change in shoulder extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer |
| Between-group change in elbow flexion strength | 12 weeks | Between-group change in elbow flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer |
| Between-group change in elbow extension strength | 12 weeks | Between-group change in elbow extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer |
| Between-group change in knee extension strength | 12 weeks | Between-group change in knee extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer |
| Between-group change in knee flexion strength | 12 weeks | Between-group change in knee flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer |
| Between-group change in hip extension strength | 12 weeks | Between-group change in hip extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer |
| Between-group change in resting energy expenditure | 12 weeks | Between-group change in resting energy expenditure (kcal/day) assessed using a metabolic cart |
| Between-group change in resting metabolic rate | 12 weeks | Between-group change in resting metabolic rate (kcal/day) assessed using a metabolic cart |
| Between-group change in respiratory quotient | 12 weeks | Between-group change in respiratory quotient (ratio) assessed using a metabolic cart |
| Appearance congruence | 12 weeks | Change in appearance congruence (utilizing the appearance congruence subscale score from Transgender Congruence Scale) in resistance exercise group |
| Gender identity acceptance | 12 weeks | Change in gender identity acceptance (utilizing the gender identity acceptance subscale score from Transgender Congruence Scale) in resistance exercise group |
| Between-group change in appearance congruence | 12 weeks | Between-group change in appearance congruence (utilizing the appearance congruence subscale score from Transgender Congruence Scale) |
| Between-group change in gender identity acceptance | 12 weeks | Between-group change in gender identity acceptance (utilizing the gender identity acceptance subscale score from Transgender Congruence Scale) |
Countries
United States
Contacts
CONTACTMabel Toribio, MD
Outcome results
None listed