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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention Group | Experimental | Thse patients will undergo a sub-maximal exercise training as treatment for concussion. |
|
| Usual Care Group | No Intervention | These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sub-maximal exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at initial visit and 8-weeks. |
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| End-tidal CO2 | Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits. | Measured at initial visit and 8-week post injury visit. |
| Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Meehan, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30376513 | Background | Howell DR, Taylor JA, Tan CO, Orr R, Meehan WP 3rd. The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Med Sci Sports Exerc. 2019 Apr;51(4):647-652. doi: 10.1249/MSS.0000000000001829. | |
| 31198074 | Background | Howell DR, Lugade V, Taksir M, Meehan WP 3rd. Determining the utility of a smartphone-based gait evaluation for possible use in concussion management. Phys Sportsmed. 2020 Feb;48(1):75-80. doi: 10.1080/00913847.2019.1632155. Epub 2019 Jun 26. |
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Recruitment period: September 1, 2018 - November 1, 2020
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who were enrolled in the study and randomized into the 2 intervention groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Concussed participants who completed exercise testing at baseline and 8-week visits. | Posted | Mean | Standard Deviation | cm s-1 mmHg-1/mmHg CO2 | Measured at initial visit and 8-weeks. |
|
Adverse event data were collected throughout each participant's enrollment in the study. This included at their initial visit, 4-weeks post injury, and 8-weeks post injury.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Meehan | Boston Children's Hospital | 781-216-1328 | william.meehan@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2020 | Mar 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Patients will be randomly assigned to either the exercise intervention group or the usual care group.
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|
Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits.
| Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic. |
| 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. | Average volume of exercise (min) that was self-reported by participants over the 8-week study period. |
| 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. | Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic |
| 31522997 | Background | Howell DR, Brilliant AN, Oldham JR, Berkstresser B, Wang F, Meehan WP 3rd. Exercise in the first week following concussion among collegiate athletes: Preliminary findings. J Sci Med Sport. 2020 Feb;23(2):112-117. doi: 10.1016/j.jsams.2019.08.294. Epub 2019 Sep 7. |
| 31985574 | Background | Howell DR, Oldham J, Lanois C, Koerte I, Lin AP, Berkstresser B, Wang F, Meehan WP 3rd. Dual-Task Gait Recovery after Concussion among Female and Male Collegiate Athletes. Med Sci Sports Exerc. 2020 May;52(5):1015-1021. doi: 10.1249/MSS.0000000000002225. |
| 31657636 | Background | Howell DR, Brilliant AN, Meehan WP 3rd. Tandem Gait Test-Retest Reliability Among Healthy Child and Adolescent Athletes. J Athl Train. 2019 Dec;54(12):1254-1259. doi: 10.4085/1062-6050-525-18. Epub 2019 Oct 28. |
| 34320557 | Derived | Howell DR, Hunt DL, Oldham JR, Aaron SE, Meehan WP 3rd, Tan CO. Postconcussion Exercise Volume Associations With Depression, Anxiety, and Dizziness Symptoms, and Postural Stability: Preliminary Findings. J Head Trauma Rehabil. 2022 Jul-Aug 01;37(4):249-257. doi: 10.1097/HTR.0000000000000718. Epub 2021 Jul 26. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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). | Those who reported sufficient exercise volume information during the duration of the study. | Posted | Median | Inter-Quartile Range | score on the PSCI scale | 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. |
|
|
|
| Secondary | End-tidal CO2 | Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits. | Participants enrolled in the study who completed exercise testing sessions at baseline and 8-week post injury. | Posted | Mean | Standard Deviation | mmHG | Measured at initial visit and 8-week post injury visit. |
|
|
|
| Secondary | Heart Rate | Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits. | Participants who completed exercise testing at baseline, 4-week, and 8-week follow-up visits. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic. |
|
|
|
| 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. | Those who reported sufficient exercise volume information during the duration of the study. | Posted | Median | Inter-Quartile Range | minutes | Average volume of exercise (min) that was self-reported by participants over the 8-week study period. |
|
|
|
| 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. | Those who reported RPE during initial, 4-week, and 8-week exercise tests. | Posted | Mean | Standard Deviation | units on a scale | Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| 8weeks post injury |
|
| 8-Week |
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| 8-Week |
|