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

Not Applicable

Completed

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

Registration Number: NCT03170856

Lead Sponsor: Boston Children's Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1): Spaulding Rehabilitation Hospital
🇺🇸
Cambridge, Massachusetts, United States
Spaulding Rehabilitation Hospital
🇺🇸Cambridge, Massachusetts, United States