RECRUITING

Exercise Reset for Concussion in a Military Environment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment

Quick Facts

Study Start:2024-08-07
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05498038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

John J Leddy, MD
CONTACT
7162043200
leddy@buffalo.edu
Haley Chizuk, PhD, ATC
CONTACT
7162043200
haleychi@buffalo.edu

Principal Investigator

John Leddy, MD
PRINCIPAL_INVESTIGATOR
University at Buffalo

Study Locations (Sites)

Fort Liberty
Fayetteville, North Carolina, 28310
United States
Camp LeJeune
Jacksonville, North Carolina, 28547
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

  • John Leddy, MD, PRINCIPAL_INVESTIGATOR, University at Buffalo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-07
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-08-07
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • concussion
  • military
  • aerobic exercise
  • recovery
  • return to duty

Additional Relevant MeSH Terms

  • Brain Concussion