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Completed

NCT Number: NCT03170856

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

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.

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Key information

Conditions

Concussion, Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Concussion, Brain Concussion, Severe Craniocerebral Trauma Exertion; Excess Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.

    Time frame: 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.

  2. Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.

    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.

    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 outcomes

  1. End-tidal CO2

    Time frame: 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.

  2. Heart Rate

    Time frame: 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.

  3. Volume of Self-reported Exercise Per Week

    Time frame: 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.

  4. Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • University of Colorado, Denver

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
May 31, 2017
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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