Aerobic Exercise for Traumatic Brain Injury

(AER-TBI1 Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Centre for Neuro Skills

Disqualifiers: Degenerative neurological, Stroke, Major psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise might aid recovery from traumatic brain injury (TBI). Researchers aim to determine if exercise can enhance brain recovery by promoting brain changes and reducing inflammation. Participants will be divided into groups: one will perform aerobic exercises alongside standard rehab, another will receive only standard rehab, and a healthy control group will be included. The trial seeks individuals who have experienced a TBI, can exercise with or without support, and can walk independently. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that aerobic exercise is a safe and promising method to aid individuals with traumatic brain injury (TBI). Studies have found that it can enhance heart health and improve cognitive skills in TBI survivors. Aerobic exercise is non-invasive, requiring neither surgery nor medication, which generally makes it manageable for participants.

Reports also suggest that aerobic exercise can reduce fatigue and elevate mood in people with TBI, contributing to better overall recovery. In past cases, aerobic exercise has helped lessen symptoms and accelerate recovery in teenagers with mild traumatic brain injuries.

Overall, aerobic exercise is considered a safe option that positively impacts both physical and mental health for those recovering from TBI. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using aerobic exercise for traumatic brain injury (TBI) because it offers a non-invasive way to potentially enhance recovery. Unlike traditional treatments like medication or surgery, aerobic exercise focuses on improving brain health through physical activity, which can increase blood flow and promote brain plasticity. The idea is that regular aerobic exercise could enhance cognitive and physical rehabilitation outcomes more effectively than standard rehabilitation alone. This approach is especially promising because it might provide a holistic benefit, improving overall well-being and quality of life for TBI patients.

What evidence suggests that aerobic exercise might be an effective treatment for traumatic brain injury?

Research shows that aerobic exercise can help people recover from a traumatic brain injury (TBI). In this trial, participants will receive either an aerobic exercise regimen combined with standard rehabilitation or standard rehabilitation alone. Studies have found that aerobic exercise improves brain function in areas like thinking, remembering, and problem-solving. It can also enhance mood and overall fitness. Some research suggests it reduces symptoms and speeds up recovery, especially in younger individuals with mild brain injuries. Although more research is needed, early findings are promising for those recovering from TBI. ^{1 3 4 5 6}

Who Is on the Research Team?

Grace S Griesbach, PhD

Principal Investigator

Centre for Neuro Skills

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

All participants will provide informed consent and have to comply with the procedures of the study

Except for the non-injured control group, subjects will be required to have experienced TBI

All participants should have the ability to comply with the research protocol

Exclusion Criteria

I have been diagnosed with a degenerative neurological disease.

A history of major psychosis as defined by DSM-IV

I have had a stroke before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluations including cognitive function, life quality, and balance assessments

1 week

Treatment

Participants undergo a 12-week aerobic exercise regimen with follow-ups at weeks 4, 8, and 12

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise (AER)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Aerobic Exercise (AER) Experimental Treatment 1 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: Rehabilitation (R) Active Control 1 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.

Group III: Control (C) Active Control 1 Intervention

Healthy volunteers' responsiveness to exercise will be compared to TBI responsiveness.

Who Is Running the Clinical Trial?

Centre for Neuro Skills

Lead Sponsor

Trials

4

Recruited

570+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

A survey of 155 Canadian physical therapists revealed that 88% believe aerobic exercise (AE) should be included in treatment for patients with neurological conditions, highlighting its recognized importance in neurorehabilitation.

Despite 77% of therapists prescribing AE, barriers such as patient concerns about safety and operational challenges like lack of staff and time hinder its implementation, indicating a need for improved screening and training procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of aerobic exercise in adult neurological rehabilitation by physical therapists in Canada. Doyle, L., Mackay-Lyons, M.[2022]

An 8-week progressive aerobic exercise program was found to be feasible and well tolerated by five individuals recovering from moderate to severe traumatic brain injury (TBI), indicating that aerobic exercise can be safely integrated into their rehabilitation.

Participants successfully adhered to both the aerobic exercise and cognitive training, although measuring exercise intensity was challenging due to poor correlations between heart rate reserve and perceived effort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Aerobic Exercise in the Subacute Phase of Recovery From Traumatic Brain Injury: A Case Series. Morris, TP., Costa-Miserachs, D., Rodriguez-Rajo, P., et al.[2021]

A 3-month community-based aerobic exercise training program showed a trend toward improved cardiorespiratory fitness (CRF) in individuals with traumatic brain injury (TBI), with an 8% increase in VO2peak compared to a 4% decrease in a stretching and toning group, indicating potential efficacy of aerobic exercise for this population.

The study demonstrated that while it is feasible to conduct exercise training in community settings for TBI patients, only 50% of participants adhered to the program, highlighting the need for strategies to improve adherence in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. Ding, K., Tarumi, T., Tomoto, T., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10771390/

Brain changes: aerobic exercise for traumatic brain injury ... While aerobic exercise may meet many of these criteria, it is currently unknown how effective it is as a treatment for TBI across age and injury severity.

2. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-024-00993-4

Aerobic exercise and cognitive function in chronic severe ... Aerobic exercise is a non-invasive behavioral intervention with promise to treat cognitive deficits in TBI populations.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02504866

Effect of Exercise Training on Physical, Cognitive, and ... The broad objective of this study is to examine the effects of moderate and more intense aerobic exercise as an intervention on cognitive performance, physical ...

4. psychiatrictimes.com psychiatrictimes.com/view/benefits-of-aerobic-exercise-following-traumatic-brain-injury

Benefits of Aerobic Exercise Following Traumatic Brain Injury Following a brain injury, aerobic exercise promotes cardiovascular fitness, cognitive recovery, and reductions in mood disorders.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875020321628

Therapeutic Effect of Aerobic Exercise for Adolescents After ... The present meta-analysis indicated that aerobic exercise can significantly lower the PCSS score and shorten the recovery time in adolescents with SRC or mTBI.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01294332?term=AREA%5BBasicSearch%5D(11-CC-0088)&rank=1

Effect of Aerobic Exercise Training on Cardiorespiratory ... - To examine the effect of an aerobic treadmill walking exercise program on physical fitness, fatigue, and mood in people with TBI. Eligibility: - Individuals ...