Exercise Treatment for Traumatic Brain Injury

((TOBI-SET) Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jason M Bailie, Phd

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: United States Naval Medical Center, San Diego

Disqualifiers: Recent TBI, Neurological disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Prescribed sub-symptomatic adaptable exercise treatment (SAET) is a potential solution that promotes recovery needs following a TBI. SAET has been shown to benefit the mind and body in ways that decrease the severity and frequency of mild TBI (mTBI) symptoms. This study aims to validate SAET as an alternative, adaptable treatment or SMs with mTBI that focuses on reducing symptoms, improving mental health, increasing physiological functioning, and ultimately returning to duty. The objective of this study is to develop a prescribed exercise treatment program for warfighters with mTBI that can be personalized for SM's needs (i.e., medical and occupational) and is adaptable to various clinical resources (e.g., forward operating bases, rural clinics, and mTBI specialty programs). The key question raised by this study is whether SAET is more effective than a stretching control group (SCG) in reducing neurobehavioral symptoms among SMs with persistent complaints following a mTBI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Stretching Control Group (SCG), Stretching, Physical Therapy, Exercise Therapy, Sub-symptomatic Adaptable Exercise Treatment (SAET), Sub-symptomatic Adaptable Exercise Treatment, SAET, Sub-symptom Threshold Aerobic Exercise, SSTAE for traumatic brain injury?

Research shows that sub-symptom threshold aerobic exercise (SSTAE), which involves exercising at a level that doesn't worsen symptoms, can help reduce symptoms and improve exercise tolerance in people with persistent post-concussion symptoms after a mild traumatic brain injury. This approach has been associated with symptom improvement in several studies, suggesting it may be a promising treatment for post-concussion syndrome. ^{1 2 3 4 5}

Is subsymptom threshold aerobic exercise safe for humans?

Subsymptom threshold aerobic exercise, which involves exercising at a level that doesn't worsen symptoms, has been studied for post-concussion syndrome and is generally considered safe, with no adverse events reported in the studies reviewed. ^{1 2 4 5 6}

How is the Sub-symptomatic Adaptable Exercise Treatment (SAET) different from other treatments for traumatic brain injury?

SAET is unique because it involves exercising at a level that doesn't worsen symptoms, which can help reduce symptoms and improve exercise tolerance after a traumatic brain injury. Unlike traditional rest-based approaches, this method encourages controlled physical activity to aid recovery. ^{1 2 3 4 7}

Research Team

Jason M Bailie, Phd

Principal Investigator

Traumatic Brain Injury Center of Excellence (TBICoE)

Eligibility Criteria

This trial is for military service members (SMs) who have experienced a mild traumatic brain injury (mTBI), commonly known as a concussion, and are still dealing with symptoms. The program aims to be adaptable for individual medical needs and available resources.

Inclusion Criteria

I am an active duty service member between 18 and 55 years old.

I have had a mild traumatic brain injury over a month ago.

I am a service member with ongoing symptoms.

Exclusion Criteria

I had a brain injury within the last month.

History of moderate, severe, or penetrating TBI

Current substance use disorder

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Sub-symptomatic Adaptable Exercise Treatment (SAET) or the Stretching Control Group (SCG) intervention for 8 weeks, with sessions conducted both in-clinic and independently.

8 weeks

2 in-clinic visits per week, 3 independent sessions per week

Follow-up

Participants are monitored for changes in neurobehavioral symptoms, cognitive impairment, physiological adaptation, and occupational performance.

6 months

Treatment Details

Interventions

• Stretching Control Group (SCG) (Behavioural Intervention)
• Sub-symptomatic Adaptable Exercise Treatment (SAET) (Behavioural Intervention)

Trial Overview The study compares two approaches: Sub-symptomatic Adaptable Exercise Treatment (SAET), which is personalized exercise designed to reduce mTBI symptoms, versus a Stretching Control Group (SCG) that serves as the comparison group.

Participant Groups

Group I: Sub-symptomatic Adaptable Exercise Treatment (SAET) Experimental Treatment 1 Intervention

Participants will attend two in-clinic sessions per week with either a licensed Physical Therapist or Exercise Physiologist and complete three sessions per week independently outside of the clinic. Each session will be 1 hour in duration, 5 days a week for 8 weeks, for a total of 40 hours. Participants will complete a combination of aerobic and resistance training exercises prescribed and adapted to the participant's personal needs based on evaluations by the Physical Therapist and Exercise Physiologist. Exercise will be adjusted to maintain sub-symptomatic levels, meaning that if a participant's neurobehavioral symptoms increase with activity, the intensity and/or exercise will be modified. Furthermore, participants will be asked to fill out an Exercise Habits Questionnaire (EHQ) in order to capture the exercises they are currently doing.

Group II: Stretching Control Group (SCG) Active Control 1 Intervention

Participants will attend two in-clinic sessions per week with either a licensed Physical Therapist or Exercise Physiologist and complete three sessions per week independently outside of the clinic. Each session will be 1 hour in duration, 5 days a week for 8 weeks, for a total of 40 hours. The stretching exercises are designed not to increase heart rate or have excessive head motion consist of static stretching and yoga based movements.

Who Is Running the Clinical Trial?

United States Naval Medical Center, San Diego

Lead Sponsor

Trials

110

Recruited

24,200+

Captain Morlock

United States Naval Medical Center, San Diego

Chief Executive Officer since 2023

Bachelor of Science in Biology from the University of South Dakota, MBA in 2001

Captain Elizabeth M. Adriano

United States Naval Medical Center, San Diego

Chief Medical Officer since 2023

MD

Findings from Research

A study involving 56 adults with persistent post-concussive symptoms (PPCS) will assess the effectiveness of a 12-week progressive aerobic exercise program in reducing symptom burden, compared to a delayed start stretching protocol.

The primary outcome will be measured using the Rivermead Post-concussion Symptom Questionnaire, with additional evaluations of specific symptoms and brain metabolites, aiming to provide insights into the benefits of aerobic exercise for adults with PPCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving symptom burden in adults with persistent post-concussive symptoms: a randomized aerobic exercise trial protocol. Mercier, LJ., Fung, TS., Harris, AD., et al.[2023]

A study involving 12 patients with post-concussion syndrome showed that subsymptom threshold exercise training is safe and leads to significant improvements in exercise capacity and reduction of PCS symptoms over 2 to 3 weeks.

Participants were able to exercise longer and at higher heart rates without exacerbating symptoms, with athletes recovering faster than nonathletes, indicating that controlled exercise can be an effective treatment for PCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Leddy, JJ., Kozlowski, K., Donnelly, JP., et al.[2022]

Aerobic exercise is increasingly recognized as a beneficial rehabilitation technique for individuals recovering from concussions, as it can help reduce symptoms and improve overall function.

The review highlights that while exercise is promising, the optimal parameters for recovery—such as frequency, duration, and intensity—are still not well defined, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Howell, DR., Taylor, JA., Tan, CO., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Sub-symptom threshold aerobic exercise for patients with persisting post-concussion symptoms and exercise intolerance after mild traumatic brain injury - a study protocol with a nested feasibility study for a randomized controlled trial. [2023]

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

Adolescents with Sport-Related Concussion Who Adhere to Aerobic Exercise Prescriptions Recover Faster. [2023]

3. Denmark pubmed.ncbi.nlm.nih.gov

Physical exercise ameliorates deficits induced by traumatic brain injury. [2012]

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

The Role of Subsymptom Threshold Aerobic Exercise for Persistent Concussion Symptoms in Patients With Postconcussion Syndrome: A Systematic Review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Improving symptom burden in adults with persistent post-concussive symptoms: a randomized aerobic exercise trial protocol. [2023]

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

A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. [2022]

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

The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. [2020]