Resistance exercise and nutrition support for transgender women and gender-diverse adults starting estrogen therapy
Effects of Resistance Exercise Among TGD Individuals Initiating Estrogen-Based Gender-Affirming Hormone Therapy
This will test whether a resistance exercise program plus nutrition counseling helps preserve or improve muscle mass and strength in transgender women and gender-diverse adults who are starting estrogen-based hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07400419 on ClinicalTrials.gov |
What this trial studies
This interventional program enrolls adults assigned male at birth who identify as transgender women or gender-diverse and are initiating estrogen-based gender-affirming hormone therapy with androgen suppression. Participants receive a supervised resistance exercise program combined with nutrition and exercise counseling, with baseline and follow-up measures of muscle mass, strength, and function. The protocol targets early changes in appendicular lean mass and muscular performance that could signal increased sarcopenia risk after starting estrogen therapy. Outcomes will compare muscle and functional measures over time between those receiving the intervention and expected changes from prior cohorts.
Who should consider this trial
Good fit: Adults (≥18) assigned male at birth who identify as transgender female/woman or gender-diverse, are initiating estradiol plus androgen suppression, and are medically able to participate in a resistance exercise program.
Not a fit: People with medical contraindications to resistance exercise, significant mobility limitations, recent prolonged testosterone use, or those already established on gender-affirming hormones are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could help preserve or increase muscle mass and strength and reduce the risk of sarcopenia among TGD individuals starting estrogen-based hormone therapy.
How similar studies have performed: Resistance training reliably increases muscle mass and strength in general populations, and prior work has shown declines in lean mass after estrogen-based GAHT, but few interventional trials have tested resistance programs specifically in TGD people starting estrogen therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 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 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Mabel Toribio, MD
- Email: mptoribio@mgh.harvard.edu
- Phone: 617-724-2826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.