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NCT07400419 · ClinicalTrials.gov registry record · NA
Effects of Resistance Exercise Among TGD Individuals Initiating Estrogen-Based Gender-Affirming Hormone Therapy
A NA study, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT07400419: Recruiting NA study, sponsored by Massachusetts General Hospital.
NCT07400419 is a NA study that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07400419, a NA study, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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 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 wheth
Interventions
- BEHAVIORAL Nutrition and Exercise Counseling
- BEHAVIORAL Resistance Exercise Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-04-16 |
| Est. Completion | 2028-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07400419
The ClinicalTrials.gov registry entry for NCT07400419 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nutrition and Exercise Counseling is the first listed.
NCT07400419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07400419 about?
NCT07400419 is a clinical study titled "Effects of Resistance Exercise Among TGD Individuals Initiating Estrogen-Based Gender-Affirming Hormone Therapy". 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...
What is the current status of trial NCT07400419?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2026-04-16. Estimated completion is 2028-04-01.
What interventions are being tested in trial NCT07400419?
The interventions under investigation include: Nutrition and Exercise Counseling (BEHAVIORAL), Resistance Exercise Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT07400419?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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