Concussion, MildNCT03569709
Early Sub-threshold Exercise Treatment for Concussion
A study testing Aerobic Exercise, Rest and Stretching in people with Concussion, Mild, run by State University of New York at Buffalo.
Trial summary
Each year millions of Americans suffer concussions as a result of accidents in sports, at work or through military service. Adolescents take the longest to recover from the effects of concussion yet no therapy exists to help speed their recovery. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Aerobic Exercise, Rest and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2018to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13-18 years; any race, ethnicity, or sex.
- Concussion sustained 2-7 days prior to first clinical visit.
- Symptom score (new symptoms) >3 on the Post-Concussion Symptom Inventory Scale.
- Glasgow Coma Scale (GCS) of 13-15 (if available in medical record), an alteration in mental status, loss of consciousness (if present) of less than 30 minutes, and post-traumatic amnesia (if present) limited to <24 hours.
- Low risk for cardiac disease and willing to exercise.
- Medications, except for βeta- and calcium-blockers, are acceptable.
Who cannot join
- GCS score <13 at time of injury.
- Lesion on CT/MRI (via review of emergency department records) and/or focal neurologic deficit consistent with an intracerebral lesion (e.g., unilateral weakness, dilated pupil).
- Inability to exercise because of orthopedic injury, significant vestibular dysfunction, visual abnormality, or increased cardiac risk.
- Neurosurgical intervention, general anesthesia and previously diagnosed neurological or psychiatric diseases.
- Additional head injury after study enrollment.
- Active substance abuse/dependence.
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- Non-fluency in English.
- βeta- and calcium blocker use.
- Autism, metal braces or other metal that would interfere with ASL.
- Unwilling to exercise.
About this study
Official title: Guided Aerobic Exercise Therapy to Improve Recovery From Acute Concussion: A Randomized Controlled Trial
Each year millions of Americans suffer concussions as a result of accidents in sports, at work or through military service. Adolescents take the longest to recover from the effects of concussion yet no therapy exists to help speed their recovery. This project aims to see if a program of early guided aerobic exercise can safely speed recovery from concussion in adolescents and investigates some reasons for why this type of therapy could be effective.
Read the detailed description
Most children with concussion recover spontaneously within 2-4 weeks of injury but approximately 30% experience prolonged post-concussive symptoms (PPCS), impacting quality of life. There are no evidence-based therapies for acute pediatric concussion. Instead, current consensus-based-recommendations include physical and cognitive rest as the mainstays of treatment despite evidence to the contrary that excessive rest prolongs recovery and that early (first week) activity reduces PPCS incidence. The investigators were the first to demonstrate that a systematic evaluation of exercise tolerance using the Buffalo Concussion Treadmill Test (BCTT) to prescribe a guided exercise prescription in those with PPCS safely sped recovery. The investigators have preliminary data that exercise may speed recovery if administered within the first week after sport-related concussion (SRC). Concussion is associated with adverse effects on the autonomic nervous system (ANS) and control of cerebral blood flow (CBF). The investigators have shown that sub-threshold aerobic exercise reduces symptoms in PPCS in association with normalization of ANS function and CBF control, providing a potential mechanism of action as well as target engagement for this non-pharmacological therapy. An important translational aspect is that the BCTT would be for clinicians a clinical proxy of concussion physiology that would help make the difficult return-to-activity/play decision more objective and physiologically-based. The investigators' long-term goals are to develop therapies that safely speed recovery from concussion, return youth back to their typical activities, actively prevent PPCS, and develop practical physiological tools for clinicians. The overall objective of this application is to determine if early guided aerobic exercise speeds recovery from SRC. The investigators specifically test underlying mechanisms of action for faster recovery by measuring ANS function (the cold pressor test, CPT) and CBF (by Arterial Spin Labeling, ASL). Age- and sex-matched healthy controls will be recruited to quantify physiological CBF differences and serve as a normative control group. The investigators will examine these questions in a randomized, multisite controlled trial in adolescents aged 13-18y with acute SRC by pursuing the following two specific aims: (1) determine if guided aerobic exercise/education speeds recovery after acute concussion in adolescents compared with (a) rest/education with a gradual return to activities, (i.e., current recommendation) and (b) a progressive stretching program/education (attention placebo); and (2) as secondary aims the investigators will quantify the effects of each intervention in Aim 1 on CBF and on autonomic function (CPT), which serve as relevant and objective physiological measures of autonomic regulation of CBF following concussion. This project will provide critical evidence to support the role of guided aerobic exercise for the active treatment of acute concussion and for a physiological mechanism(s) for its effect, which would lead to a paradigm shift from the current passive approach to treatment. The translational aspect of the project is unique and would have immediate impact to help clinicians determine recovery based on physiology rather than symptoms. A controlled active approach to concussion treatment may also substantially reduce the incidence of PPCS in children.
- Conditions
- Concussion, Mild
- Being tested
- Aerobic Exercise, Rest, Stretching
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Progressive sub-threshold aerobic exercise
RestBehavioural
No structured exercise.
StretchingBehavioural
Gentle progressive upper and lower extremity stretching program
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Active comparator | Sub-threshold aerobic exercise. Receives: Behavioral: Aerobic Exercise |
| Stretching | Placebo comparator | Stretching program that will not raise heart rate. Receives: Behavioral: Stretching |
| Rest | Placebo comparator | Relative rest. Avoid all structured exercise. Receives: Behavioral: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery
Time to baseline level of symptoms on Post Concussion Symptom Inventory (PCSI) for 2 days in a row
Measured: up to 2 days
Secondary outcomes (3)
Autonomic function
Autonomic function as assessed by the Cold Pressor Test (CPT)
Measured: Within one week of injury and at 1 month after injury
Delayed recovery
Persistence of increased symptoms on the PCSI at 1 and at 4 months after concussion
Measured: 1 and 4 months after concussion
Cerebral Blood Flow (CBF)
CBF by Arterial Spin Labelling MRI
Measured: Within one week of injury and at 1 month after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start15 Jun 2018 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Harvard University, The Mind Research Network
- Responsible party
- Principal investigator, John J. Leddy MD, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569709
- Sponsor's protocol ID
- 1 R01 NS106260-01
- Status last verified
- Oct 2020
- First submitted
- 5 Jun 2018
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Aerobic Exercise Therapy to Improve Recovery From Acute Concussion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03569709
- Acronym / sponsor ID
- 1 R01 NS106260-01
- Conditions
- Concussion, Mild
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Harvard University, The Mind Research Network
- Study start
- 15 Jun 2018 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Each year millions of Americans suffer concussions as a result of accidents in sports, at work or through military service. Adolescents take the longest to recover from the effects of concussion yet no therapy exists to help speed their recovery. This project aims to see if a program of early guided aerobic exercise can safely speed recovery from concussion in adolescents and investigates some reasons for why this type of therapy could be effective.
Detailed description
Most children with concussion recover spontaneously within 2-4 weeks of injury but approximately 30% experience prolonged post-concussive symptoms (PPCS), impacting quality of life. There are no evidence-based therapies for acute pediatric concussion. Instead, current consensus-based-recommendations include physical and cognitive rest as the mainstays of treatment despite evidence to the contrary that excessive rest prolongs recovery and that early (first week) activity reduces PPCS incidence. The investigators were the first to demonstrate that a systematic evaluation of exercise tolerance using the Buffalo Concussion Treadmill Test (BCTT) to prescribe a guided exercise prescription in those with PPCS safely sped recovery. The investigators have preliminary data that exercise may speed recovery if administered within the first week after sport-related concussion (SRC). Concussion is associated with adverse effects on the autonomic nervous system (ANS) and control of cerebral blood flow (CBF). The investigators have shown that sub-threshold aerobic exercise reduces symptoms in PPCS in association with normalization of ANS function and CBF control, providing a potential mechanism of action as well as target engagement for this non-pharmacological therapy. An important translational aspect is that the BCTT would be for clinicians a clinical proxy of concussion physiology that would help make the difficult return-to-activity/play decision more objective and physiologically-based. The investigators' long-term goals are to develop therapies that safely speed recovery from concussion, return youth back to their typical activities, actively prevent PPCS, and develop practical physiological tools for clinicians. The overall objective of this application is to determine if early guided aerobic exercise speeds recovery from SRC. The investigators specifically test underlying mechanisms of action for faster recovery by measuring ANS function (the cold pressor test, CPT) and CBF (by Arterial Spin Labeling, ASL). Age- and sex-matched healthy controls will be recruited to quantify physiological CBF differences and serve as a normative control group. The investigators will examine these questions in a randomized, multisite controlled trial in adolescents aged 13-18y with acute SRC by pursuing the following two specific aims: (1) determine if guided aerobic exercise/education speeds recovery after acute concussion in adolescents compared with (a) rest/education with a gradual return to activities, (i.e., current recommendation) and (b) a progressive stretching program/education (attention placebo); and (2) as secondary aims the investigators will quantify the effects of each intervention in Aim 1 on CBF and on autonomic function (CPT), which serve as relevant and objective physiological measures of autonomic regulation of CBF following concussion. This project will provide critical evidence to support the role of guided aerobic exercise for the active treatment of acute concussion and for a physiological mechanism(s) for its effect, which would lead to a paradigm shift from the current passive approach to treatment. The translational aspect of the project is unique and would have immediate impact to help clinicians determine recovery based on physiology rather than symptoms. A controlled active approach to concussion treatment may also substantially reduce the incidence of PPCS in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Active comparator | Behavioral: Aerobic ExerciseSub-threshold aerobic exercise. |
| Stretching | Placebo comparator | Behavioral: StretchingStretching program that will not raise heart rate. |
| Rest | Placebo comparator | Behavioral: RestRelative rest. Avoid all structured exercise. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 13-18 years; any race, ethnicity, or sex.
- Concussion sustained 2-7 days prior to first clinical visit.
- Symptom score (new symptoms) >3 on the Post-Concussion Symptom Inventory Scale.
- Glasgow Coma Scale (GCS) of 13-15 (if available in medical record), an alteration in mental status, loss of consciousness (if present) of less than 30 minutes, and post-traumatic amnesia (if present) limited to <24 hours.
- Low risk for cardiac disease and willing to exercise.
Key exclusion criteria (10 listed)
- GCS score <13 at time of injury.
- Lesion on CT/MRI (via review of emergency department records) and/or focal neurologic deficit consistent with an intracerebral lesion (e.g., unilateral weakness, dilated pupil).
- Inability to exercise because of orthopedic injury, significant vestibular dysfunction, visual abnormality, or increased cardiac risk.
- Neurosurgical intervention, general anesthesia and previously diagnosed neurological or psychiatric diseases.
- Additional head injury after study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseProgressive sub-threshold aerobic exercise | Behavioural | Aerobic Exercise |
| RestNo structured exercise. | Behavioural | Rest |
| StretchingGentle progressive upper and lower extremity stretching program | Behavioural | Stretching |
Primary outcome
Time to recovery
Time frame: up to 2 days
Time to baseline level of symptoms on Post Concussion Symptom Inventory (PCSI) for 2 days in a row
3 secondary outcomes
Autonomic function
Time frame: Within one week of injury and at 1 month after injury
Delayed recovery
Time frame: 1 and 4 months after concussion
Cerebral Blood Flow (CBF)
Time frame: Within one week of injury and at 1 month after injury
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Rest and Stretching in people with Concussion, Mild, run by State University of New York at Buffalo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery (time frame: up to 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020; AzTrials last refreshed its copy on 27 Oct 2026.