Concussion, Brain, Concussion, Mild, Concussion, Severe, Exertion; Excess
Conditions
Brief summary
Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.
Detailed description
There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.
Interventions
OTHERSub-maximal exercise
Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.
Sponsors
University of Colorado, Denver
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomly assigned to either the exercise intervention group or the usual care group.
Eligibility
Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment * Low or moderate cardiac risk according to American College of Sports Medicine * Post-Concussion Symptom Scale (PCSS) score greater than 9
Exclusion criteria
* History of neurological surgery * Seizure disorder * Use of medication or medical device that would alter heart rate, blood pressure or autonomic function * Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity * Unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vasoreactivity During Exercise at Baseline and 8-week Visits. | Measured at initial visit and 8-weeks. | Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer. |
| Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. | The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study. | Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End-tidal CO2 | Measured at initial visit and 8-week post injury visit. | Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits. |
| Heart Rate | Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic. | Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits. |
| Volume of Self-reported Exercise Per Week | Average volume of exercise (min) that was self-reported by participants over the 8-week study period. | Volume exercise was monitored by self-reported exercise diary. All participants were asked to track their exercise and complete weekly exercise logs for the 8-week study duration. The participants randomized into the Exercise Intervention Group were prescribed a specific heart rate to exercise 5x/week for 8-weeks. Heart rate was determined by their performance from the corresponding exercise testing visit. Participants enrolled in the Usual Care Group were not prescribed any specific exercise. These participants were instructed to follow their Doctors requests. Values are presented as average minutes of exercise throughout the 8-week study period. |
| Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. | Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic | Using the Borg Scale. The Borg scale is a way of measuring physical intensity level. The scale ranges from 6- no exertion at all, to 20- maximal exertion. The higher the RPE reported, the harder the participant perceives themselves to be physically working. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: September 1, 2018 - November 1, 2020
Participants by arm
| Arm | Count |
|---|---|
| Exercise Intervention Group Thse patients will undergo a sub-maximal exercise training as treatment for concussion.
Sub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate. | 20 |
| Usual Care Group These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician. | 21 |
| Total | 41 |
Baseline characteristics
| Characteristic | Exercise Intervention Group | Usual Care Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 14 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Continuous | 17.3 years STANDARD_DEVIATION 1.9 | 16.6 years STANDARD_DEVIATION 2.2 | 16.9 years STANDARD_DEVIATION 2.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 20 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 17 Participants | 33 Participants |
| Region of Enrollment United States | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.
Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem).
Time frame: The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study.
Population: Those who reported sufficient exercise volume information during the duration of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Concussed Participant Group | Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. | Initial | 15 score on the PSCI scale |
| Concussed Participant Group | Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. | 4weeks post injury | 4 score on the PSCI scale |
| Concussed Participant Group | Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. | 8weeks post injury | 6.5 score on the PSCI scale |
| Usual Care Group | Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. | Initial | 20 score on the PSCI scale |
| Usual Care Group | Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. | 4weeks post injury | 5.5 score on the PSCI scale |
| Usual Care Group | Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. | 8weeks post injury | 0 score on the PSCI scale |
Primary
Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.
Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer.
Time frame: Measured at initial visit and 8-weeks.
Population: Concussed participants who completed exercise testing at baseline and 8-week visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Concussed Participant Group | Change in Vasoreactivity During Exercise at Baseline and 8-week Visits. | Baseline | 0.031 cm s-1 mmHg-1/mmHg CO2 | Standard Deviation 0.013 |
| Concussed Participant Group | Change in Vasoreactivity During Exercise at Baseline and 8-week Visits. | 8-week | 0.028 cm s-1 mmHg-1/mmHg CO2 | Standard Deviation 0.01 |
Secondary
End-tidal CO2
Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits.
Time frame: Measured at initial visit and 8-week post injury visit.
Population: Participants enrolled in the study who completed exercise testing sessions at baseline and 8-week post injury.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Concussed Participant Group | End-tidal CO2 | Baseline | 33.4 mmHG | Standard Deviation 3 |
| Concussed Participant Group | End-tidal CO2 | 8-week | 33.2 mmHG | Standard Deviation 2.6 |
Secondary
Heart Rate
Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits.
Time frame: Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.
Population: Participants who completed exercise testing at baseline, 4-week, and 8-week follow-up visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Concussed Participant Group | Heart Rate | Baseline Baseline | 162.5 beats per minute (bpm) | Standard Deviation 19 |
| Concussed Participant Group | Heart Rate | 4-Week | 171.1 beats per minute (bpm) | Standard Deviation 9.6 |
| Concussed Participant Group | Heart Rate | 8-Week | 170.2 beats per minute (bpm) | Standard Deviation 8.1 |
| Usual Care Group | Heart Rate | 4-Week | 170 beats per minute (bpm) | Standard Deviation 9.8 |
| Usual Care Group | Heart Rate | Baseline Baseline | 164.5 beats per minute (bpm) | Standard Deviation 14.9 |
| Usual Care Group | Heart Rate | 8-Week | 167.4 beats per minute (bpm) | Standard Deviation 12.3 |
Secondary
Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.
Using the Borg Scale. The Borg scale is a way of measuring physical intensity level. The scale ranges from 6- no exertion at all, to 20- maximal exertion. The higher the RPE reported, the harder the participant perceives themselves to be physically working.
Time frame: Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic
Population: Those who reported RPE during initial, 4-week, and 8-week exercise tests.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Concussed Participant Group | Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. | baseline | 15.8 units on a scale | Standard Deviation 2.3 |
| Concussed Participant Group | Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. | 4-Week | 16.7 units on a scale | Standard Deviation 1.8 |
| Concussed Participant Group | Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. | 8-Week | 16.7 units on a scale | Standard Deviation 1.9 |
| Usual Care Group | Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. | baseline | 15.4 units on a scale | Standard Deviation 1.7 |
| Usual Care Group | Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. | 4-Week | 15.5 units on a scale | Standard Deviation 1.9 |
| Usual Care Group | Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. | 8-Week | 15.1 units on a scale | Standard Deviation 2.1 |
Secondary
Volume of Self-reported Exercise Per Week
Volume exercise was monitored by self-reported exercise diary. All participants were asked to track their exercise and complete weekly exercise logs for the 8-week study duration. The participants randomized into the Exercise Intervention Group were prescribed a specific heart rate to exercise 5x/week for 8-weeks. Heart rate was determined by their performance from the corresponding exercise testing visit. Participants enrolled in the Usual Care Group were not prescribed any specific exercise. These participants were instructed to follow their Doctors requests. Values are presented as average minutes of exercise throughout the 8-week study period.
Time frame: Average volume of exercise (min) that was self-reported by participants over the 8-week study period.
Population: Those who reported sufficient exercise volume information during the duration of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Concussed Participant Group | Volume of Self-reported Exercise Per Week | 115 minutes |
| Usual Care Group | Volume of Self-reported Exercise Per Week | 88 minutes |