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

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to examine the effects of individualized aerobic exercise regimen on recovery after traumatic brain injury (TBI).Investigators will determine if exercise facilitates recovery by facilitating neuroplasticity and decreasing neuroinflammation.

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 aerobic exercise safe for people with traumatic brain injury?

Aerobic exercise has been shown to be safe for people with traumatic brain injury, with no adverse events reported in studies. It is important to follow structured exercise protocols and consider the timing of exercise initiation to ensure safety and maximize benefits. ^{1 2 3 4 5}

How does aerobic exercise treatment differ from other treatments for traumatic brain injury?

Aerobic exercise is unique for traumatic brain injury as it can improve brain health by enhancing cardiorespiratory fitness and cognitive performance, and it may help reduce symptoms like depression and anxiety. Unlike other treatments, it involves physical activity that engages cerebrovascular mechanisms, potentially offering neurophysiologic benefits and promoting recovery. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Aerobic Exercise (AER) for Traumatic Brain Injury?

Research suggests that aerobic exercise can improve cognitive performance and cardiorespiratory fitness in people with traumatic brain injury (TBI). It may also help reduce symptoms like depression and anxiety, and promote brain health by engaging cerebrovascular mechanisms. ^{1 2 3 5 7}

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 should have the ability to comply with the research protocol

I can walk on my own, with or without help like a cane.

I can use aerobic exercise equipment, with help if needed.

Exclusion Criteria

I have been diagnosed with a degenerative neurological disease.

I have had a stroke before.

A history of major psychosis as defined by DSM-IV

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 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]

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 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Improved cognitive performance following aerobic exercise training in people with traumatic brain injury. [2019]

2. England pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Independent, Community-Based Aerobic Exercise Training for People With Moderate-to-Severe Traumatic Brain Injury. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Aerobic Exercise in the Subacute Phase of Recovery From Traumatic Brain Injury: A Case Series. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Neurologic benefits of sports and exercise. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Graded Aerobic Treadmill Testing in Adolescent Traumatic Brain Injury Patients. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Utilization of aerobic exercise in adult neurological rehabilitation by physical therapists in Canada. [2022]