Low Volume Aerobic Exercise for Concussion, Brain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UB MD Orthopeadics & Sports Medicine, Buffalo, NY
Concussion, Brain+1 More
Low Volume Aerobic Exercise - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
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Study Summary

The overarching purpose of this proposed research is to determine whether BDNF and/or specific miRNAs can serve as biomarkers for recovery from a concussion during prescribed exercise. The investigators hypothesize salivary BDNF and specific miRNA signatures will change in a statistically significant manner as participants proceed from injury to recovery and participants who show recovery in ANS regulation will show significant differences in salivary BDNF and specific miRNA expression. This study also aims to determine if BDNF and/or specific miRNA can serve as biomarkers of the return of ANS function in concussed patients. The basic premise here is that the volume of exercise will significantly affect the rate of change in the expression of salivary BDNF and miRNA from injury to recovery.

Eligible Conditions

  • Concussion, Brain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 28 days

28 days
Persistent Post Concussion Symptoms (PPCS) (Yes/No)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Healthy controls Group 1
1 of 4
Healthy Controls Group 2
1 of 4
Concussed Participants Group 2
1 of 4
Concussed Participants Group 1
1 of 4
Active Control
Experimental Treatment

48 Total Participants · 4 Treatment Groups

Primary Treatment: Low Volume Aerobic Exercise · No Placebo Group · N/A

Concussed Participants Group 2
Behavioral
Experimental Group · 1 Intervention: Low Volume Aerobic Exercise · Intervention Types: Behavioral
Concussed Participants Group 1
Behavioral
Experimental Group · 1 Intervention: High Volume Aerobic Exercise · Intervention Types: Behavioral
Healthy controls Group 1
Behavioral
ActiveComparator Group · 1 Intervention: High Volume Aerobic Exercise · Intervention Types: Behavioral
Healthy Controls Group 2
Behavioral
ActiveComparator Group · 1 Intervention: Low Volume Aerobic Exercise · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days
Closest Location: UB MD Orthopeadics & Sports Medicine · Buffalo, NY
Photo of new york 1Photo of new york 2Photo of new york 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Concussion, Brain
0 CompletedClinical Trials

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
208 Previous Clinical Trials
44,192 Total Patients Enrolled
Barry Willer, PhDStudy ChairUniversity at Buffalo
John Leddy, MDStudy DirectorUniversity at Buffalo
2 Previous Clinical Trials
228 Total Patients Enrolled
Praveen Arany, DDS, PhDPrincipal InvestigatorUniversity at Buffalo
Mohammad Nadir, MD, PhDStudy DirectorUniversity at Buffalo

Eligibility Criteria

Age < 65 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.