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}

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Intrepid Spirit Center Camp Pendleton, CA

Who Is Running the Clinical Trial?

United States Naval Medical Center, San Diego Lead Sponsor

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] Persistent post-concussion symptoms (PPCS) affect between 34 and 46% after a mild traumatic brain injury (mTBI). Many also experience exercise intolerance. Sub-symptom threshold aerobic exercise, SSTAE (exercise at an intensity level that does not increase symptoms) is proposed as a treatment to both reduce the symptom burden and increase the exercise tolerance after the injury. It is unclear if this also applies in a more chronic phase after mTBI.

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

Adolescents with Sport-Related Concussion Who Adhere to Aerobic Exercise Prescriptions Recover Faster. [2023] There is growing evidence that subsymptom threshold aerobic exercise speeds recovery from sport-related concussion (SRC). It is not known whether there is a direct relationship between adherence to a personalized exercise prescription and recovery or if initial symptom burden affects adherence to the prescription.

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

Physical exercise ameliorates deficits induced by traumatic brain injury. [2012] The extent and depth of traumatic brain injury (TBI) remains a major determining factor together with the type of structural insult and its location, whether mild, moderate or severe, as well as the distribution and magnitude of inflammation and loss of cerebrovascular integrity, and the eventual efficacy of intervention. The influence of exercise intervention in TBI is multiple, ranging from anti-apoptotic effects to the augmentation of neuroplasticity. Physical exercise diminishes cerebral inflammation by elevating factors and agents involved in immunomodulatory function, and buttresses glial cell, cerebrovascular, and blood-brain barrier intactness. It provides unique non-pharmacologic intervention that incorporate different physical activity regimes, whether dynamic or static, endurance or resistance. Physical training regimes ought necessarily to be adapted to the specific demands of diagnosis, type and degree of injury and prognosis for individuals who have suffered TBI.

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] In recent years, there has been a shift away from rest until total symptom resolution after concussion, due to the potential adverse consequences of inactivity. Aerobic exercise has been increasingly investigated for the treatment of postconcussion syndrome, whereby symptoms persist beyond 4 wks. The aim of this review was to systematically review the literature on subsymptom threshold aerobic exercise as a treatment for postconcussion syndrome. We conducted systematic literature searches in databases: MEDLINE (Ovid), CINAHL, PubMed, and Embase. After thorough review, 12 articles met the eligibility criteria and were included in the systematic review. The quality of selected studies was low to moderate. Subsymptom threshold aerobic exercise was associated with improvement in symptoms in patients with postconcussion syndrome for all included studies. The most commonly used protocols incorporated 20 mins of exercise at 80% of the heart rate that provoked symptoms, 5-6 days per week, with no adverse events documented. However, there was considerable variation in exercise protocols, and many studies incorporated subsymptom threshold aerobic exercise as part of a broader rehabilitation plan. Evidence supports subsymptom threshold aerobic exercise as a promising treatment for postconcussion syndrome. Further studies are required to delineate the optimal intensity, duration, and frequency of exercise for postconcussion syndrome in a variety of populations.

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

Improving symptom burden in adults with persistent post-concussive symptoms: a randomized aerobic exercise trial protocol. [2023] Persistent post-concussive symptoms (PPCS) affect up to 30% of individuals following mild traumatic brain injury. PPCS frequently includes exercise intolerance. Sub-symptom threshold aerobic exercise has been proposed as a treatment option for symptom burden and exercise intolerance in this population. The primary aim of this study is to evaluate whether a progressive, sub-symptom threshold aerobic exercise program can alleviate symptom burden in adults with PPCS.

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

A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. [2022] To evaluate the safety and effectiveness of subsymptom threshold exercise training for the treatment of post-concussion syndrome (PCS).

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

The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. [2020] Aerobic exercise has received increasing attention in the scientific literature as a component of management for individuals who sustain a concussion. Because exercise training has been reported to reduce symptoms and improve function for those experiencing persistent postconcussion symptoms, it represents a potentially useful and clinically pragmatic rehabilitation technique. However, the specific exercise parameters that best facilitate recovery from concussion remain poorly defined and unclear. This review will provide a summary of the current understanding of the role of subsymptom exercise to improve outcomes after a concussion and will describe the exercise parameters that appear to be important. The latter will take into account the three pillars of exercise dose-frequency, duration, and intensity-to examine what is currently known. In addition, we identify important gaps in our knowledge of exercise as a treatment for those who develop persistent symptoms of concussion.