Aerobic Exercise for Concussion
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byJohn Leddy, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: State University of New York at Buffalo
Must not be taking: ADHD medication, Mood stabilizers
Disqualifiers: Severe TBI, Orthopedic injury, Substance abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery.
Will I have to stop taking my current medications?
If you are currently taking medications that affect autonomic function, like ADHD medication or mood stabilizers, you may not be eligible to participate in this trial.
What data supports the effectiveness of aerobic exercise as a treatment for concussion?
Is aerobic exercise safe for people recovering from a concussion?
How is aerobic exercise different from other treatments for concussion?
Aerobic exercise is unique for concussion treatment because it involves gradually introducing light-to-moderate intensity physical activity after an initial rest period, which is a shift from the traditional recommendation of complete rest. This approach aims to safely improve recovery time without worsening symptoms, unlike other treatments that may not incorporate physical activity.6781011
Eligibility Criteria
This trial is for military personnel aged 18-40 who have been diagnosed with a concussion within the past 9 days. Participants must be diagnosed by a clinician using international standards.Inclusion Criteria
Diagnosed with concussion by an experienced clinician using standard international criteria
I am between 18 and 40 years old.
My injury occurred within the last 9 days.
Exclusion Criteria
I have had a serious brain injury confirmed by a scan or specific symptoms.
History of more than 3 diagnosed concussions
Injury involving loss of consciousness for >30 minutes or post-traumatic amnesia >24 hours
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive early, personalized aerobic exercise treatment in addition to the Department of Defense Progressive Return to Activity protocol
4 weeks
Weekly visits for multi-modal assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on persistent post-concussive symptoms and recovery
3 months
Treatment Details
Interventions
- Aerobic Exercise (Behavioral Intervention)
Trial OverviewThe study tests whether personalized aerobic exercise can help improve recovery from concussion, speed up return to duty (RTD), and reduce long-term symptoms in combat service members.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Concussed Service Members PRA+ExerciseExperimental Treatment1 Intervention
CSM allocated to this group will complete PRA protocols/ will receive treatment as usual and will receive an exercise program in addition to PRA.
Group II: Healthy Control Service MembersActive Control1 Intervention
Non-concussed, age-matched SM will serve as a healthy control group (HC) for comparing CSM to normal physiology and to control for the effect of time and of aerobic exercise. They will not be given intervention.
Group III: Concussed Service Members PRAActive Control1 Intervention
CSM allocated to this group will complete PRA protocols/ will receive treatment as usual.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fort LibertyFayetteville, NC
Camp LeJeuneJacksonville, NC
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Who Is Running the Clinical Trial?
State University of New York at BuffaloLead Sponsor
Axon Medical Technologies LLCIndustry Sponsor
The Geneva FoundationCollaborator
United States Department of DefenseCollaborator
University of PennsylvaniaCollaborator
University of North Carolina, Chapel HillCollaborator
Center for Neuroscience and Regenerative Medicine (CNRM)Collaborator
Quadrant Biosciences Inc.Industry Sponsor
Geneva FoundationCollaborator
Children's Hospital of PhiladelphiaCollaborator
References
Earlier time to aerobic exercise is associated with faster recovery following acute sport concussion. [2019]To determine whether earlier time to initiation of aerobic exercise following acute concussion is associated with time to full return to (1) sport and (2) school or work.
Return to full functioning after graded exercise assessment and progressive exercise treatment of postconcussion syndrome. [2022]Exercise assessment and aerobic exercise training for postconcussion syndrome (PCS) may reduce concussion-related physiological dysfunction and symptoms by restoring autonomic balance and improving cerebral blood flow autoregulation. In a descriptive pilot study of 91 patients referred to a university clinic for treatment of PCS, a subset of 63 patients were contacted by telephone for assessment of symptoms and return to full daily functioning. Those who experienced symptoms during a graded exercise treadmill test (physiologic PCS, n = 40) were compared to those who could exercise to capacity (PCS, n = 23). Both groups had been offered progressive exercise rehabilitation. Overall 41 of 57 (72%) who participated in the exercise rehabilitation program returned to full daily functioning. This included 27 of 35 (77%) from the physiologic PCS group, and 14 of 22 (64%) from the PCS group. Only 1 of the 6 patients who declined exercise rehabilitation returned to full functioning. Interpretation of these results is limited by the descriptive nature of the study, the small sample size, and the relatively few patients who declined exercise treatment. Nonetheless, exercise assessment indicates that approximately one third of those examined did not have physiologic PCS.
A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]Objective: To assess the feasibility of conducting an aerobic exercise training study in a community setting for individuals with traumatic brain injury (TBI)Methods: This is a prospective, randomized, and controlled study. Nine participants (three moderate-to-severe and six mild TBI) were randomized to a community-based 3-month individualized aerobic exercise training program (AET). Seven participants (four moderate-to-severe, three mild TBI) were randomized to a stretching and toning program (SAT). Cardiorespiratory fitness (CRF) level was assessed with peak oxygen uptake (VO2peak) testing.Results: After 3 months of training, the AET trended toward improved VO2peak when compared with the SAT group (8% vs - 4%, p = .059) with a large effect size of 1.27. Only 50% of participants in the AET group completed more than 70% of the assigned exercise sessions. No adverse events were reported. Both the AET and SAT groups reported small improvements in self-reported mood symptoms, including depression, anxiety, and anger.Conclusions: It is feasible to conduct an exercise training study and improve CRF for persons with TBI in community settings with structured exercise protocols. However, exploring methods to enhance adherence is crucial for future exercise clinical trials to improve brain health in this population.
Early Controlled Exercise and Timing of Treatment Following Concussion: A Critically Appraised Topic. [2021]Clinical Scenario: Recent systematic reviews have shown that extended rest may not be beneficial to patients following concussion. Furthermore, recent evidence has shown that patient with postconcussion syndrome benefit from an active rehabilitation program. There is currently a gap between the ability to draw conclusions to the use of aerobic exercise during the early stages of recovery along with the safety of these programs. Clinical Question: Following a concussion, does early controlled aerobic exercise, compared with either usual care or delayed exercise, improve recovery as defined by symptom duration and severity? Summary of Key Findings: After a thorough literature search, 5 studies relevant to the clinical question were selected. Of the 5 studies, 1 study was a randomized control trial, 2 studies were pilot randomized controlled trials, and 2 studies were retrospective. All 5 studies showed that implementing controlled aerobic exercise did not have an adverse effect on recovery. One study showed early aerobic exercise had a quicker return to school, and another showed a 2-day decrease in symptom duration. Clinical Bottom Line: There is sufficient evidence to suggest that early controlled aerobic exercise is safe following a concussion. Although early aerobic exercise may not always result in a decrease in symptom intensity and duration, it may help to improve the psychological state resulting from the social isolation of missing practices and school along with the cessation of exercise. Although treatments continue to be a major area of research following concussion, management should still consist of an interdisciplinary approach to individualized patient care. Strength of Recommendation: There is grade B evidence to support early controlled aerobic exercise may reduce the duration of symptoms following recovery while having little to no adverse events.
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.
Efficacy of aerobic exercise following concussion: a narrative review. [2023]Concussion is a type of mild traumatic brain injury which results in symptoms within the physical, cognitive, emotional, and sleep domains. Historically, guidelines established by expert opinion have recommended rest during the initial stages of recovery following a concussion until symptom resolution. However, recent recommendations have shifted to advise an initial period of 24-48 h of rest immediately following concussion with the gradual introduction of light-to-moderate intensity aerobic exercise thereafter. Given the relatively recent transition in recommendations, the aim of this review is to provide an overview of the current literature on the efficacy of aerobic exercise following concussion. The current literature is limited to studies assessing the impact of standardized aerobic exercise following concussion. Upon review, literature suggests participating in aerobic exercise below the point of symptom exacerbation is safe in both the acute and chronic post-concussion symptom stages of recovery and does not delay time to medical clearance. Future large-scale randomized controlled trials assessing the impact of aerobic exercise and differences between males and females would help support the current evidence suggesting aerobic exercise could improve time to recovery following concussion and identify any sex differences in response. As well, future studies with the purpose of identifying optimal aerobic exercise volume and intensity in the treatment of concussion could improve the specificity of the current guidelines.
Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants. [2020]Aerobic exercise interventions are increasingly being prescribed for concussion rehabilitation, but whether aerobic training protocols influence clinical concussion diagnosis and management assessments is unknown.
Symptom Provocation During Aerobic and Dynamic Supervised Exercise Challenges in Adolescents With Sport-Related Concussion. [2022]Supervised exercise challenges (SECs) have been shown to be safe and beneficial in the early symptomatic period after concussion. Thus far, most in-clinic SECs studied have included a form of basic aerobic exercise only. An SEC that also includes dynamic forms of exercise mimics all steps of a standard return-to-play progression and may enhance the detection of concussion symptoms to guide in-clinic management decisions.
Graded aerobic treadmill testing in pediatric sports-related concussion: safety, clinical use, and patient outcomes. [2022]OBJECTIVE The objectives of this study were 2-fold: 1) to evaluate the safety, tolerability, and clinical use of graded aerobic treadmill testing in pediatric patients with sports-related concussion (SRC), and 2) to evaluate the clinical outcomes of treatment with a submaximal aerobic exercise program in patients with physiological post-concussion disorder (PCD). METHODS The authors conducted a retrospective chart review of pediatric patients (age
Sex differences in self-reported symptoms after aerobic exercise in non-injured athletes: implications for concussion management programmes. [2009]After a concussion, when symptoms have decreased substantially at rest, it is recommended that athletes begin light aerobic exercise before progressing to sport specific exercise. The British Columbia Concussion Rehabilitation Programme (BC-CRP) uses a standardized cognitive and exercise test protocol designed to indicate when an athlete should progress to sport-specific exercise after a concussion.
Feasibility of Aerobic Exercise in the Subacute Phase of Recovery From Traumatic Brain Injury: A Case Series. [2021]Aerobic exercise is as important for individuals with traumatic brain injury (TBI) as for the general population; however, the approach to aerobic training may require some adaptation. The objective of the trial program was to examine the feasibility of introducing aerobic physical exercise programs into the subacute phase of multidisciplinary rehabilitation from moderate to severe TBI, which includes computerized cognitive training.