- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03569709
Early Sub-threshold Exercise Treatment for Concussion
October 16, 2020 updated by: John J. Leddy MD, State University of New York at Buffalo
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Non-fluency in English.
- βeta- and calcium blocker use.
- Autism, metal braces or other metal that would interfere with ASL.
- Unwilling to exercise.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aerobic Exercise
Sub-threshold aerobic exercise.
|
Progressive sub-threshold aerobic exercise
|
Placebo Comparator: Stretching
Stretching program that will not raise heart rate.
|
Gentle progressive upper and lower extremity stretching program
|
Placebo Comparator: Rest
Relative rest.
Avoid all structured exercise.
|
No structured exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autonomic function
Time Frame: Within one week of injury and at 1 month after injury
|
Autonomic function as assessed by the Cold Pressor Test (CPT)
|
Within one week of injury and at 1 month after injury
|
Delayed recovery
Time Frame: 1 and 4 months after concussion
|
Persistence of increased symptoms on the PCSI at 1 and at 4 months after concussion
|
1 and 4 months after concussion
|
Cerebral Blood Flow (CBF)
Time Frame: Within one week of injury and at 1 month after injury
|
CBF by Arterial Spin Labelling MRI
|
Within one week of injury and at 1 month after injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 15, 2018
Primary Completion (Anticipated)
December 15, 2020
Study Completion (Anticipated)
December 15, 2020
Study Registration Dates
First Submitted
June 5, 2018
First Submitted That Met QC Criteria
June 25, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
October 20, 2020
Last Update Submitted That Met QC Criteria
October 16, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 R01 NS106260-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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