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NCT05498038 · ClinicalTrials.gov registry record · NA

Exercise Reset for Concussion in a Military Environment

A NA study of Brain Concussion, sponsored by State University of New York at Buffalo.

Recruiting
Registry status
NA
Development phase
168
Enrollment target
2
Study locations

NCT05498038 is a NA study of Brain Concussion that is actively recruiting participants, run by State University of New York at Buffalo. The registered enrollment target is 168 participants, below the 288-participant average among 17 other Brain Concussion trials with a reported enrollment target (42% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT05498038, a NA study of Brain Concussion, is actively recruiting participants, sponsored by State University of New York at Buffalo.

RECRUITING
Registry status
NA
Development phase
168 participants
Enrollment target
2
Study locations

Study Summary

Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery. We will conduct a prospective four-year multicenter mechanistic treatment (Phase 3) RCT in CSM of personalized sub-threshold aerobic exercise added to the PRA compared with the PRA alone. Non-concussed, age-matched SM will serve as a healthy control group (HC) for comparing CSM to normal physiology and to control for the effect of time and of aerobic exercise.

Conditions Studied

Interventions

  • BEHAVIORAL Aerobic Exercise

Study Locations (2)

North Carolina

  • Fort Liberty - Fayetteville
  • Camp LeJeune - Jacksonville

Trial Details

FieldValue
Enrollment Target 168 participants
Start Date 2024-08-07
Est. Completion 2026-09-30
Phase NA

What the Registry Record Tells You About NCT05498038

The ClinicalTrials.gov registry entry for NCT05498038 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 17 other Brain Concussion trials with a reported enrollment target (42% lower). The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Brain Concussion appearing as the primary indexed condition, and to 1 intervention - of which Aerobic Exercise is the first listed.

NCT05498038 reports 2 study locations spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT05498038 about?

NCT05498038 is a clinical study titled "Exercise Reset for Concussion in a Military Environment". Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mec...

What is the current status of trial NCT05498038?

This trial is currently recruiting. It is a NA study. The enrollment target is 168 participants. The study started on 2024-08-07. Estimated completion is 2026-09-30.

What conditions does trial NCT05498038 study?

This clinical trial studies the following conditions: Brain Concussion.

What interventions are being tested in trial NCT05498038?

The interventions under investigation include: Aerobic Exercise (BEHAVIORAL).

Who is sponsoring clinical trial NCT05498038?

This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05498038 being conducted?

This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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