Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455969
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
Adaptions and Resiliency to Multi-Stressor OpeRations
Sponsor:
Bradley Nindl
Organization:
University of Pittsburgh
Study Overview
Official Title:
Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARMOR
Brief Summary:
Non-combat-related muscle tendon and bone injuries are the most common injuries suffered by military personnel particularly in new recruits These injuries impact military readiness and are responsible for roughly 60 of limited duty days 65 of soldiers who are unable to deploy and nearly 500 million in medical cost to the government annually in the Army alone Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service At the current time military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps
The goal of this study is to determine how a hormonal intervention can change muscle tendon and bone function as well as physical and psychological performance in response to mental and physical stress To do so we will examine sex hormone testosterone estrogen levels muscle tendon and bone images blood samples and physical and mental performance We will look at things like changes in hormone levels chemicals released from active skeletal muscles and your body composition The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries
The goal of this study is to determine how a hormonal intervention can change muscle tendon and bone function as well as physical and psychological performance in response to mental and physical stress To do so we will examine sex hormone testosterone estrogen levels muscle tendon and bone images blood samples and physical and mental performance We will look at things like changes in hormone levels chemicals released from active skeletal muscles and your body composition The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries
Detailed Description:
Suppression of the reproductive hypothalamic-pituitary-gonadal HPG axis is a common physiological response to strenuous military training and can be difficult to replicate in simulated environments Additionally whether HPG suppression contributes to the physiological changes performance decrements and high MSK injury risk associated with multi-stressor military training is unknown Thus we will utilize pharmacological inhibition of the HPG axis to test if estrogen and testosterone replacement will mitigate injury risk and performance decrements following military-relevant multi-stressor training This project aims to deliver a state-of-the-art evaluation of male and female adaptive responses to multi-stressor training and evidence-based guidance for the safe and ethical use of exogenous hormone replacement as a MSK injury mitigation solution during multi-stressor training and operations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None