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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). 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
Primary Outcome
Change in appendicular lean mass/height\^2 (kg/m\^2) assessed via whole body DEXA in resistance exercise group
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 |
What NCT07400419 shows while recruiting
NCT07400419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Nutrition and Exercise Counseling is the first listed.
NCT07400419 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07400419's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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