Exercises for Concussion

(TECHS Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northeastern University

Disqualifiers: Moderate-to-severe TBI, Neurological condition, Cardiac conditions, others

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

Compensation: Varies

Number of Visits: 39

Duration: 12 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to investigate the effect of two different physical exercise interventions on the brain, cognition and patient reported outcomes following a mild traumatic brain injury (mTBI) in community-dwelling adults. Physical exercise as an intervention for mTBI has great potential yet there is limited high-quality evidence of its effect. Additionally, while standardized exercise protocols for sport-related concussion exist, a similar program is not available to members of the general public who have suffered a mTBI. This study therefore aims to test the effect of a 3-month exercise protocol either focusing on balance or aerobic exercises. The results from the study may lead to advances in evidenced-based mTBI management and provide clinicians with an effective intervention that can improve brain and cognitive recovery after mTBI.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are being treated for certain cardiovascular conditions or have had recent cardiac events, you may be excluded from participating.

What data supports the idea that Exercises for Concussion is an effective treatment?

The available research shows that exercises for concussion, such as aerobic exercise and balance training, can help people recover from concussion symptoms. In one study, 72% of participants who did exercise rehabilitation returned to full daily functioning, compared to only 1 out of 6 who did not do the exercises. Another study found that a combination of vestibular rehabilitation and aerobic training helped adults with persistent concussion symptoms. These findings suggest that exercise can be an effective way to improve recovery after a concussion. ^{1 2 3 4 5}

What safety data exists for exercise treatments for concussion?

Research indicates that aerobic exercise, including supervised and controlled programs, is safe for individuals with concussion. Studies show that exercise conducted at subsymptom and submaximal intensities does not negatively impact long-term recovery and may be beneficial. This includes aerobic exercise, vestibular rehabilitation, and dynamic exercise challenges. The safety and potential benefits of these exercises have been supported by multiple randomized controlled trials. ^{1 6 7 8 9}

Is aerobic exercise and balance exercise a promising treatment for concussion recovery?

Yes, aerobic exercise and balance exercise are promising treatments for concussion recovery. Research shows that starting light aerobic exercise after symptoms decrease can help athletes recover faster. It also reduces the chance of long-lasting symptoms, especially in adolescents with more severe concussion signs. Combining aerobic exercise with balance training can improve recovery outcomes. ^{1 6 7 10 11}

Eligibility Criteria

This trial is for adults living in the community who have experienced a mild traumatic brain injury (mTBI) or concussion. The study seeks participants to test exercise interventions aimed at improving brain and cognitive recovery.

Inclusion Criteria

Signed Informed consent

Able to speak, read, and write English

MRI compatible

Exclusion Criteria

I have been diagnosed with a cognitive or physical disability.

I am not fluent in English.

I have had a stroke or brain bleed in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants sign informed consent and undergo baseline assessments including MRI, EEG, cognition tests, and lifestyle questionnaires

1 day

1 visit (in-person)

Treatment

Participants engage in a 12-week exercise intervention focusing on either aerobic or balance exercises, with remote sessions conducted via Zoom

12 weeks

36 remote sessions (via Zoom)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with endpoint assessments including MRI, EEG, and cognitive tests

1 day

1 visit (in-person)

Treatment Details

Interventions

• Aerobic Exercise
• Balance Exercise

Trial Overview The study is testing two types of physical exercises: balance and aerobic exercises. Participants will follow a 3-month exercise protocol to see which type better aids recovery after mTBI.

Participant Groups

Group I: Aerobic Exercise Group Experimental Treatment 1 Intervention

Group II: Balance Exercise Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northeastern University

Lead Sponsor

Trials

103

Recruited

72,600+

Findings from Research

In a study of 14 adults with persistent concussion symptoms, a 6-month supervised home exercise program combining vestibular rehabilitation and aerobic training led to significant improvements in concussion-related symptoms and functional abilities, as measured by various clinical assessments.

Participants showed notable progress in returning to work and engaging in meaningful activities, with statistical significance in measures related to symptom reduction and balance confidence, indicating the effectiveness of this rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes Following a Vestibular Rehabilitation and Aerobic Training Program to Address Persistent Post-Concussion Symptoms. Moore, BM., Adams, JT., Barakatt, E.[2018]

In a pilot study of 91 patients with postconcussion syndrome (PCS), those who participated in a progressive exercise rehabilitation program showed a high return to full daily functioning, with 72% overall success, including 77% from the physiologic PCS group.

Only 1 out of 6 patients who declined exercise rehabilitation returned to full functioning, suggesting that engaging in exercise may be crucial for recovery from PCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Return to full functioning after graded exercise assessment and progressive exercise treatment of postconcussion syndrome. Baker, JG., Freitas, MS., Leddy, JJ., et al.[2022]

In a small clinical trial with 12 adults with traumatic brain injury (TBI), an 8-week program of rapid-resisted elliptical training significantly improved dynamic balance and motor processing speed, as measured by the High-Level Mobility Assessment Tool (HiMAT) and dual-task performance.

The training not only enhanced physical abilities but also positively impacted sleep quality, which correlated with reductions in depression and improvements in learning, highlighting the interconnectedness of physical and cognitive recovery in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a rapid-resisted elliptical training program on motor, cognitive and neurobehavioral functioning in adults with chronic traumatic brain injury. Damiano, DL., Zampieri, C., Ge, J., et al.[2023]

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]

A review of 20 studies on non-aerobic exercise interventions for improving balance and gait in individuals with mild-to-moderate traumatic brain injury (TBI) found limited evidence of effectiveness, highlighting the need for better quality research.

The studies reviewed often had small sample sizes and varied methodologies, indicating that future research should focus on standardizing interventions and outcome measures to provide clearer insights into their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. Bland, DC., Zampieri, C., Damiano, DL.[2021]

Early aerobic exercise prescribed within 10 days of a sport-related concussion (SRC) significantly reduces recovery times, even for adolescents with more severe symptoms, as indicated by a hazard ratio of 0.621.

Adolescents with more than three abnormal oculomotor and vestibular signs had a higher incidence of persistent post-concussive symptoms (38%) when assigned to a placebo-like stretching group, compared to only 21% in the aerobic exercise group, suggesting that aerobic exercise may help mitigate long-term symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents With More Oculomotor and Vestibular Signs of Sport-Related Concussion Benefit from Aerobic Exercise: An Exploratory Analysis. Corrado, C., Willer, BS., McPherson, JI., et al.[2023]

In a study of 65 adolescent athletes with sport-related concussions, a dynamic supervised exercise challenge (DSEC) was more effective at uncovering concussion symptoms than a basic aerobic supervised exercise challenge (ASEC), with 37% of previously asymptomatic patients developing symptoms during the DSEC.

The findings suggest that incorporating dynamic exercises into concussion assessments can enhance symptom detection, which is crucial for guiding safe return-to-play decisions in young athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom Provocation During Aerobic and Dynamic Supervised Exercise Challenges in Adolescents With Sport-Related Concussion. Popovich, M., Sas, A., Almeida, AA., et al.[2022]

Aerobic exercise at subsymptom and submaximal intensities is safe for individuals with sports-related concussions, as shown in four randomized controlled trials that included supervised exercise starting within one week of injury.

Controlled exercise may benefit adolescents with persistent concussion symptoms, and while symptom changes can occur, they do not negatively impact long-term recovery, supporting a shift from traditional rest to active rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation Utilizing Controlled Aerobic Activity in Patients With a Concussion: A Critically Appraised Topic. Prince, J., Schussler, E., McCann, R.[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]

In a study involving 75 amateur athletes (45 females and 30 males), light aerobic exercise after a concussion led to increased reports of balance problems and somatic symptoms for both genders, indicating that some symptoms may temporarily worsen post-exercise.

Women experienced significant reductions in emotional symptoms like irritability and sadness after aerobic exercise, while men did not show significant changes in headache or emotional symptoms, highlighting important sex differences in symptom response post-concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in self-reported symptoms after aerobic exercise in non-injured athletes: implications for concussion management programmes. Gaetz, MB., Iverson, GL.[2009]

A brief aerobic exercise intervention improved total symptom scores in healthy participants, indicating some positive effects on concussion-related symptoms after training, with scores decreasing from 5.1 to 1.9 over two sessions.

Despite some improvements in symptoms and cognitive flexibility, the overall changes were small and did not significantly affect clinical concussion assessment tools, suggesting that these tools remain stable regardless of aerobic exercise training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants. Teel, EF., Register-Mihalik, JK., Appelbaum, LG., et al.[2020]

References

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

Outcomes Following a Vestibular Rehabilitation and Aerobic Training Program to Address Persistent Post-Concussion Symptoms. [2018]

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

Return to full functioning after graded exercise assessment and progressive exercise treatment of postconcussion syndrome. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Effects of a rapid-resisted elliptical training program on motor, cognitive and neurobehavioral functioning in adults with chronic traumatic brain injury. [2023]

4. 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]

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

Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. [2021]

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

Adolescents With More Oculomotor and Vestibular Signs of Sport-Related Concussion Benefit from Aerobic Exercise: An Exploratory Analysis. [2023]

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

Symptom Provocation During Aerobic and Dynamic Supervised Exercise Challenges in Adolescents With Sport-Related Concussion. [2022]

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

Rehabilitation Utilizing Controlled Aerobic Activity in Patients With a Concussion: A Critically Appraised Topic. [2021]

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

Sex differences in self-reported symptoms after aerobic exercise in non-injured athletes: implications for concussion management programmes. [2009]

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

Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants. [2020]