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Behavioural Intervention
Aerobic Exercise for Traumatic Brain Injury (AER-TBI1 Trial)
Phase 1 & 2
Waitlist Available
Led By Grace S Griesbach, PhD
Research Sponsored by Centre for Neuro Skills
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
AER-TBI1 Trial Summary
This trial looks at whether personalized aerobic exercise can help the brain heal from a traumatic injury and reduce inflammation.
Who is the study for?
This trial is for individuals aged 18-60 who have experienced a traumatic brain injury (TBI) and can exercise on aerobic equipment. They must understand English or Spanish, be able to walk with or without support, and commit to the study's procedures. People with degenerative neurological diseases, major psychosis, previous severe TBI, certain physical therapies outside CNS, pregnancy, orthopedic issues affecting exercise ability or serious heart/lung conditions cannot join.Check my eligibility
What is being tested?
The study is testing whether an individualized aerobic exercise program helps recovery after TBI by promoting brain plasticity and reducing inflammation in the brain. Participants will engage in tailored aerobic exercises as part of their rehabilitation process.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from participating could include typical risks associated with aerobic exercise such as muscle soreness, fatigue, joint pain or exacerbation of existing injuries if not properly monitored.
AER-TBI1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aerobic Exercise Induced Changes in Cardio Pulmonary (CPET) at Week 12
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 4
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 8
+1 moreSecondary outcome measures
5-HT1A / C1019G at Week 12
5-HT1A / C1019G at Week 4
5-HT1A / C1019G at Week 8
+89 moreAER-TBI1 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Aerobic Exercise (AER)Experimental Treatment1 Intervention
Consented participants will be randomly assigned to aerobic exercise regimen (AER) + Standard Rehabilitation(R+AER) or Standard Rehabilitation only (R) group. In order to determine the necessary time window for AER exercise treatment, TBI subjects will partake in supervised AER sessions for a period of 12 weeks. After a baseline evaluations follow-ups will take place at take place at weeks 4, 8 and 12. Thus each participants will be evaluated 4 times.
Group II: Control (C)Active Control1 Intervention
Healthy volunteers' responsiveness to exercise will be compared to TBI responsiveness.
Group III: Rehabilitation (R)Active Control1 Intervention
Participants with traumatic brain injury that are enrolled in a comprehensive rehabilitation program. These participants will receive standard rehabilitation. Given that the duration of the rehabilitative program is variable the duration of participation will be no less than 4 weeks and will not exceed 12 weeks. Activity levels will be monitored.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Centre for Neuro SkillsLead Sponsor
3 Previous Clinical Trials
383 Total Patients Enrolled
University of PittsburghOTHER
1,719 Previous Clinical Trials
16,342,151 Total Patients Enrolled
Grace S Griesbach, PhDPrincipal InvestigatorCentre for Neuro Skills
2 Previous Clinical Trials
360 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a degenerative neurological disease.I have had a stroke before.I am undergoing physical therapy outside the central nervous system.I can walk on my own, with or without help like a cane.I can use aerobic exercise equipment, with help if needed.I am unable to follow study procedures or cooperate with treatment.I have a bone or joint problem that affects my ability to exercise.I have heart or lung conditions that make exercise risky for me.I am between 18 and 60 years old.I am fluent in either English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Aerobic Exercise (AER)
- Group 2: Control (C)
- Group 3: Rehabilitation (R)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I meet the prerequisites for enrolment in this experiment?
"The inclusion criteria for this clinical trial requires that participants must have sustained a traumatic brain injury and are within the ages of 18 and 60. Approximately 190 patients will be allowed to enroll in the study."
Answered by AI
Does this research encompass adults aged 45 or older?
"This clinical trial is recruiting participants who are over 18 and below 60 years of age."
Answered by AI
Is enrollment for this clinical trial still open?
"The information on clinicaltrials.gov states that this study is no longer enrolling patients, as the last update occurred in March 14th 2021. Despite this, there are still an abundance of other medical trials actively seeking participants at present."
Answered by AI
What goals are researchers attempting to achieve through this experiment?
"The primary outcome of this medical trial, which is to be evaluated over the span of Week 4, will assess changes in Cardio Pulmonary Exercise (CPET) at Week 8. Secondary outcomes include an evaluation of Attention, processing speed, reaction times, memory and nonverbal reasoning during weeks 4, 8 and 12 using a computer based auto-scored multivariate scoring system developed by manufacturers that aggregates all scores into one reported value - named Neurocognitive Index."
Answered by AI
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