- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674620
Trial of Aerobic Treadmill Exercise Treatment for Concussion
Randomized Controlled Trial of Aerobic Treadmill Exercise Treatment for Concussion
Study Overview
Detailed Description
This is a randomized controlled trial of sub-threshold (symptom-threshold) exercise therapy versus relative rest treatment in subjects with an acute phase concussion.
If a participant is eligible and consent has been given the neurosurgeon will conduct a Physical Activity Readiness Medical Examination (PARmed-X) and the participant will complete an exercise tolerance test on a treadmill (Visit 1) under the supervision of the neurosurgeon and exercise scientist. Using a standardized Balke protocol, participants will perform an incremental treadmill test to the point of symptom onset of exacerbation (increase of 2 points on an overall condition Likert scale). Those who achieve a peak Heart Rate (HR) > 150 bpm will be excluded from the study since they are close to full recovery. Those who achieve a HR > 120 but < 150 bpm and who cannot exercise to exhaustion (defined as a final rating of perceived exertion (RPE) < 17 on a Borg scale) will be randomly assigned to sub-threshold aerobic exercise (exercise at a HR equivalent to 80% of their HR achieved at symptom onset or exacerbation) or to relative rest. Any participant who does not achieve a HR > 120 bpm will return the following week for a repeat treadmill test (Visit 2). If they achieve a HR > 120 bpm but cannot exercise to exhaustion during Visit 2, they will be randomly assigned to sub-threshold exercise or to relative rest. This is because participants must demonstrate a level of exercise tolerance to have a reasonable sub-threshold (80% of achieved HR) exercise treatment prescription.
Participants randomized to sub-threshold aerobic exercise will be given a HR monitor and a specific HR intensity to exercise at 30 minutes per day. Participants randomized to rest will be asked to rest for 30 minutes per day (no structured physical or cognitive activity for at least 30 minutes per day and no participation in structured aerobic exercise during the entire study). After randomization, all subjects will have treadmill testing at all subsequent follow-ups with the neurosurgeon (every 1 to 2 weeks) to determine physiological recovery. All participants will be asked to document their symptom data into a form between 7-10 PM each evening (following that day's exercise for the exercise group), along with hours of work/school, and minutes of exercise.
The study end point for each subject is at recovery (as determined by a normal exercise level and an exam from the treating neurosurgeon).
Data Analysis
All statistics will be presented as mean ± SD. Data will be analyzed with a two-way analysis of variance to compare physiological variables for the exercise and rest groups over the duration of the study. Total test duration, maximum heart rate achieved and peak respiratory rate will be compared between the two groups with an independent samples t-test. A repeated measures ANOVA will be used for all questionnaire analyses. All analysis will be completed using SPSS 22 (IBM corp, Armonk, NY, USA) with an alpha level set at p<0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3E4
- Pan Am Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must meet the diagnostic criteria of a concussion set forth by the Consensus Statement on Concussion in Sport 4th Annual Conference of Concussion in Sport, 2013 as determined by the treating neurosurgeon.
- Presence of concussion-related symptoms at the time of testing.
- Glasgow coma scale (GCS)=15
- Patients for who parental consent can be obtained.
Exclusion Criteria:
- Patients with a history of moderate or severe traumatic brain injury, epilepsy, or stroke.
- Patients who have been diagnosed with a skull fracture, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intraparenchymal hemorrhage, or cerebral contusion on previous neuro-imaging studies.
- Pregnant female patients.
- GCS ≤ 14.
- Patients with contraindications to exercise testing as assessed by PARmed-X assessment.
- Patients for who parental consent can not be obtained.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Conservative
Standard conservative care of concussion
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Experimental: Treadmill
Aerobic exercise treatment for concussion
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Patients are treated with progressive exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days from injury to full recovery
Time Frame: From date of injury (day 0) to date of recovery of symptoms (as defined in Outcome measure) or when the patient is discharged from care, whichever came first, assessed up to 180 days post-injury
|
To be considered at "Full recovery", participant must meet the following criteria - Asymptomatic at rest (PCSS score under 7), participating in full school activities (as pre-injury) without symptoms, normal neurological exam, and normal vestibulo-ocular exam
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From date of injury (day 0) to date of recovery of symptoms (as defined in Outcome measure) or when the patient is discharged from care, whichever came first, assessed up to 180 days post-injury
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeff R Leiter, PhD, Pan Am Clinic
Publications and helpful links
General Publications
- Leddy JJ, Baker JG, Kozlowski K, Bisson L, Willer B. Reliability of a graded exercise test for assessing recovery from concussion. Clin J Sport Med. 2011 Mar;21(2):89-94. doi: 10.1097/JSM.0b013e3181fdc721.
- Leddy JJ, Kozlowski K, Fung M, Pendergast DR, Willer B. Regulatory and autoregulatory physiological dysfunction as a primary characteristic of post concussion syndrome: implications for treatment. NeuroRehabilitation. 2007;22(3):199-205.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B2015:020
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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