Adults 14 to 21, any sex, with Concussion, Mild or Concussion, Brain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.Primary· 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.
Baseline
Group
Value
95% CI
Concussed Participant Group
0.031
± 0.013
8-week
Group
Value
95% CI
Concussed Participant Group
0.028
± 0.010
Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.Primary· 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).
Initial
Group
Value
95% CI
Exercise Intervention Group
15
10 – 42
Usual Care Group
20
11 – 35.5
4weeks post injury
Group
Value
95% CI
Exercise Intervention Group
4
0 – 28
Usual Care Group
5.5
0.5 – 21.5
8weeks post injury
Group
Value
95% CI
Exercise Intervention Group
6.5
0 – 27.5
Usual Care Group
0
0 – 4
End-tidal CO2Secondary· 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.
Baseline
Group
Value
95% CI
Concussed Participant Group
33.4
± 3.0
8-week
Group
Value
95% CI
Concussed Participant Group
33.2
± 2.6
Heart RateSecondary· 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.
Baseline Baseline
Group
Value
95% CI
Exercise Intervention Group
162.5
± 19
Usual Care Group
164.5
± 14.9
4-Week
Group
Value
95% CI
Exercise Intervention Group
171.1
± 9.6
Usual Care Group
170
± 9.8
8-Week
Group
Value
95% CI
Exercise Intervention Group
170.2
± 8.1
Usual Care Group
167.4
± 12.3
Volume of Self-reported Exercise Per WeekSecondary· 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
Group
Value
95% CI
Exercise Intervention Group
115
54 – 225
Usual Care Group
88
28 – 230
Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.Secondary· 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.
baseline
Group
Value
95% CI
Exercise Intervention Group
15.8
± 2.3
Usual Care Group
15.4
± 1.7
4-Week
Group
Value
95% CI
Exercise Intervention Group
16.7
± 1.8
Usual Care Group
15.5
± 1.9
8-Week
Group
Value
95% CI
Exercise Intervention Group
16.7
± 1.9
Usual Care Group
15.1
± 2.1
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Children's Hospital
Last refreshed: 31 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03170856.