Muscle Mass and StrengthSTRENGTHNCT07400419
Effects of Resistance Exercise Among TGD Individuals Initiating Estrogen-Based Gender-Affirming Hormone Therapy
A study testing Resistance Exercise Program and Nutrition and Exercise Counseling in people with Muscle Mass and Strength, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Muscle Mass and Strength
- What is being tested?
- Resistance Exercise Program and Nutrition and Exercise Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mabel Toribio, MD, 617-724-2826, mptoribio@mgh.harvard.edu
mptoribio@mgh.harvard.edu
About this study
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.
- Conditions
- Muscle Mass and Strength
- Being tested
- Resistance Exercise Program, Nutrition and Exercise Counseling
- Keywords
- Transgender women, Gender-Diverse, Estrogen-dominant gender-affirming hormone therapy, Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise ProgramBehavioural
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.
Nutrition and Exercise CounselingBehavioural
Participants will undergo lifestyle counseling related to optimization of their nutrition and exercise regimen.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise Intervention | Active comparator | Participants in this arm will be randomized to a 12-week at-home resistance exercise program. Receives: Behavioral: Resistance Exercise Program; Behavioral: Nutrition and Exercise Counseling |
| No exercise intervention | Placebo comparator | Participants in this arm will receive educational counseling on nutrition and exercising. Receives: Behavioral: Nutrition and Exercise Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular lean mass/height^2
Change in appendicular lean mass/height^2 (kg/m^2) assessed via whole body DEXA in resistance exercise group
Measured: 12 weeks
Gender congruence
Change in gender congruence (utilizing the total scale score from Transgender Congruence Scale) in resistance exercise group
Measured: 12 weeks
Secondary outcomes (37)
Visceral adipose tissue mass
Change in total visceral adipose tissue mass (g) assessed using whole body DEXA in resistance exercise group
Measured: 12 weeks
Visceral adipose tissue volume
Change it total visceral adipose tissue volume (cm3) assessed using whole body DEXA in resistance exercise group
Measured: 12 weeks
Total fat mass
Change in total fat mass (kg) assessed using whole body DEXA in resistance exercise group
Measured: 12 weeks
Total lean body mass
Change in total lean body mass (kg) assessed using whole body DEXA in resistance exercise group
Measured: 12 weeks
Muscular function
Change in muscular function assessed via the 5 X sit to stand test (sec) in resistance exercise group
Measured: 12 weeks
Hand-grip strength
Change in hand-grip strength (kg) assessed using a Lafayette Hand Grip Dynamometer in resistance exercise group
Measured: 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
Measured: 12 weeks
Shoulder extension strength
Change in shoulder extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Measured: 12 weeks
Elbow flexion strength
Change in elbow flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Measured: 12 weeks
Elbow extension strength
Change in elbow extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Measured: 12 weeks
Knee extension strength
Change in knee extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Measured: 12 weeks
Knee flexion strength
Change in knee flexion strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Measured: 12 weeks
Hip extension strength
Change in hip extension strength (kgf) assessed using a Hogan Scientific MicroFET2 Handheld dynamometer in resistance exercise group
Measured: 12 weeks
Resting energy expenditure
Change in resting energy expenditure (kcal/day) assessed using a metabolic cart in the resistance exercise group
Measured: 12 weeks
Resting metabolic rate
Change in resting metabolic rate (kcal/day) assessed using a metabolic cart in resistance exercise group
Measured: 12 weeks
Respiratory quotient
Change in respiratory quotient (ratio) assessed using a metabolic cart in the resistance exercise group
Measured: 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
Measured: 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
Measured: 12 weeks
Between-group change in visceral adipose tissue volume
Between-change in total visceral adipose tissue volume (cm3) assessed using whole body DEXA
Measured: 12 weeks
Between-group change in total fat mass
Between-change in total fat mass (kg) assessed using whole body DEXA
Measured: 12 weeks
Between-group change in total lean body mass
Between-group change in total lean body mass (kg) assessed using whole body DEXA
Measured: 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)
Measured: 12 weeks
Between-group change in hand-grip strength
Between-group change in hand-grip strength (kg) assessed using a Lafayette Hand Grip Dynamometer
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Between-group change in resting energy expenditure
Between-group change in resting energy expenditure (kcal/day) assessed using a metabolic cart
Measured: 12 weeks
Between-group change in resting metabolic rate
Between-group change in resting metabolic rate (kcal/day) assessed using a metabolic cart
Measured: 12 weeks
Between-group change in respiratory quotient
Between-group change in respiratory quotient (ratio) assessed using a metabolic cart
Measured: 12 weeks
Appearance congruence
Change in appearance congruence (utilizing the appearance congruence subscale score from Transgender Congruence Scale) in resistance exercise group
Measured: 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
Measured: 12 weeks
Between-group change in appearance congruence
Between-group change in appearance congruence (utilizing the appearance congruence subscale score from Transgender Congruence Scale)
Measured: 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start16 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Mass and StrengthStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mabel Toribio, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400419
- Sponsor's protocol ID
- 2025P003023
- Acronym
- STRENGTH
- Status last verified
- Sep 2026
- First submitted
- 28 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Exercise Among TGD Individuals Initiating Estrogen-Based Gender-Affirming Hormone Therapy
- ClinicalTrials.gov ID
- NCT07400419
- Acronym / sponsor ID
- STRENGTH / 2025P003023
- Conditions
- Muscle Mass and Strength
- Keywords
- Transgender women, Gender-Diverse, Estrogen-dominant gender-affirming hormone therapy, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Intervention | Active comparator | Behavioral: Resistance Exercise Program, Behavioral: Nutrition and Exercise CounselingParticipants in this arm will be randomized to a 12-week at-home resistance exercise program. |
| No exercise intervention | Placebo comparator | Behavioral: Nutrition and Exercise CounselingParticipants in this arm will receive educational counseling on nutrition and exercising. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise ProgramParticipants 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. | Behavioural | Resistance Exercise Intervention |
| Nutrition and Exercise CounselingParticipants will undergo lifestyle counseling related to optimization of their nutrition and exercise regimen. | Behavioural | No exercise intervention, Resistance Exercise Intervention |
Primary outcome
Appendicular lean mass/height^2
Time frame: 12 weeks
Change in appendicular lean mass/height^2 (kg/m^2) assessed via whole body DEXA in resistance exercise group
Gender congruence
Time frame: 12 weeks
Change in gender congruence (utilizing the total scale score from Transgender Congruence Scale) in resistance exercise group
37 secondary outcomes
Visceral adipose tissue mass
Time frame: 12 weeks
Visceral adipose tissue volume
Time frame: 12 weeks
Total fat mass
Time frame: 12 weeks
Total lean body mass
Time frame: 12 weeks
Muscular function
Time frame: 12 weeks
Hand-grip strength
Time frame: 12 weeks
Horizontal shoulder adduction strength
Time frame: 12 weeks
Shoulder extension strength
Time frame: 12 weeks
Elbow flexion strength
Time frame: 12 weeks
Elbow extension strength
Time frame: 12 weeks
Knee extension strength
Time frame: 12 weeks
Knee flexion strength
Time frame: 12 weeks
Hip extension strength
Time frame: 12 weeks
Resting energy expenditure
Time frame: 12 weeks
Resting metabolic rate
Time frame: 12 weeks
Respiratory quotient
Time frame: 12 weeks
Between-group change in appendicular lean body mass/ height^2
Time frame: 12 weeks
Between-group change in total visceral adipose tissue mass
Time frame: 12 weeks
Between-group change in visceral adipose tissue volume
Time frame: 12 weeks
Between-group change in total fat mass
Time frame: 12 weeks
Between-group change in total lean body mass
Time frame: 12 weeks
Between-group change in muscular function via the 5x sit to stand test
Time frame: 12 weeks
Between-group change in hand-grip strength
Time frame: 12 weeks
Between-group change in horizontal shoulder adduction strength
Time frame: 12 weeks
Bwtween-group change in shoulder extension strength
Time frame: 12 weeks
Between-group change in elbow flexion strength
Time frame: 12 weeks
Between-group change in elbow extension strength
Time frame: 12 weeks
Between-group change in knee extension strength
Time frame: 12 weeks
Between-group change in knee flexion strength
Time frame: 12 weeks
Between-group change in hip extension strength
Time frame: 12 weeks
Between-group change in resting energy expenditure
Time frame: 12 weeks
Between-group change in resting metabolic rate
Time frame: 12 weeks
Between-group change in respiratory quotient
Time frame: 12 weeks
Appearance congruence
Time frame: 12 weeks
Gender identity acceptance
Time frame: 12 weeks
Between-group change in appearance congruence
Time frame: 12 weeks
Between-group change in gender identity acceptance
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Program and Nutrition and Exercise Counseling in people with Muscle Mass and Strength, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mabel Toribio, MD (617-724-2826, mptoribio@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendicular lean mass/height^2 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.