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The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

Primary Purpose

Concussion, Mild, Concussion, Brain, Concussion, Severe

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sub-maximal exercise
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Mild

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Intervention Group

Usual Care Group

Arm Description

Thse patients will undergo a sub-maximal exercise training as treatment for concussion.

These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

End-tidal CO2
Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits.
Heart Rate
Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits.
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.
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.

Full Information

First Posted
May 25, 2017
Last Updated
May 6, 2022
Sponsor
Boston Children's Hospital
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03170856
Brief Title
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
Official Title
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 20, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild, Concussion, Brain, Concussion, Severe, Exertion; Excess

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly assigned to either the exercise intervention group or the usual care group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention Group
Arm Type
Experimental
Arm Description
Thse patients will undergo a sub-maximal exercise training as treatment for concussion.
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
Intervention Type
Other
Intervention Name(s)
Sub-maximal exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.
Description
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.
Title
Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.
Description
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.
Secondary Outcome Measure Information:
Title
End-tidal CO2
Description
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.
Title
Heart Rate
Description
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.
Title
Volume of Self-reported Exercise Per Week
Description
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.
Title
Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Meehan, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30376513
Citation
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.
Results Reference
background
PubMed Identifier
31198074
Citation
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.
Results Reference
background
PubMed Identifier
31522997
Citation
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.
Results Reference
background
PubMed Identifier
31985574
Citation
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.
Results Reference
background
PubMed Identifier
31657636
Citation
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.
Results Reference
background
PubMed Identifier
34320557
Citation
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.
Results Reference
derived

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The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

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