Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05498038 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Exercise Reset for Concussion in a Military Environment

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 7 entries Show 7 more changesShow less
    • Trial completed
    • Enrollment target: estimated 168 to confirmed 184
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 17 of 20 entries
    • Study description revised
    • Site details revised at 2 of 2 sites
    • Collaborators: details revised at 1 of 7 entries
  2. Primary and study completion dates: Mar 1, 2026 to Sep 30, 2026v10 Show 4 more changesShow less
    • Primary endpoints: 2 to 7
    • Eligibility criteria expanded, about 118 words
    • Secondary endpoints expanded, about 107 words
    • Study description expanded, about 24 words
  3. Site details revised at 1 of 2 sites
    • Collaborators: 8 to 7
    v9
  4. Start date changed from estimate of Sep 30, 2024 to Aug 7, 2024v8
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 1, 2024 to Sep 30, 2024
    • Study sites: 0 to 2
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Feb 1, 2024 to Jun 1, 2024v6
  2. Start date: Nov 1, 2023 to Feb 1, 2024v5
  3. Start date: Sep 1, 2023 to Nov 1, 2023v4
  4. Start date: Mar 1, 2023 to Sep 1, 2023v3
  5. Eligibility criteria shortened, about 47 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05498038
Lead Sponsor State University of New York at Buffalo
Collaborators: United States Department of Defense, Children's Hospital of Philadelphia, University of Pennsylvania, University of North Carolina, Chapel Hill, The Geneva Foundation, Center for Neuroscience and Regenerative Medicine (CNRM), Axon Medical Technologies LLC
Conditions
(from sponsor)		 Brain Concussion
Related terms Brain Concussion
Enrollment 184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov