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

NCT03170856 | Completed Results DMC

• 1 other identifier: P00024907
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild; Concussion, Brain; Concussion, Severe; Exertion; Excess

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (4)

• End-tidal CO2

  Measured at initial visit and 8-week post injury visit.

• Heart Rate

  Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.

• Volume of Self-reported Exercise Per Week

  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.

  Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic

Study Arms (2)

Exercise Intervention Group

EXPERIMENTAL

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

Other: Sub-maximal exercise

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.

Interventions

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.

Exercise Intervention Group

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (6)

• 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.

  PMID: 30376513 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.

  PMID: 31198074 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.

  PMID: 31522997 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.

  PMID: 31985574 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.

  PMID: 31657636 BACKGROUND

• 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.

  PMID: 34320557 DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Dr. William Meehan
• Organization: Boston Children's Hospital

william.meehan@childrens.harvard.edu

781-216-1328

Study Officials

• William Meehan, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Patients will be randomly assigned to either the exercise intervention group or the usual care group.

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 31, 2017
• Study Start: October 1, 2018
• Primary Completion: July 20, 2020
• Study Completion: September 1, 2021
• Last Updated: January 31, 2023
• Results First Posted: January 31, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)