N/A N=41 Randomized Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT03170856 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcome: Primary: Change in Vasoreactivity During Exercise at Baseline and 8-week Visits. — 0.031; 0.028 cm s-1 mmHg-1/mmHg CO2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sub-maximal exercise (Other)
Age: Pediatric, Adult · 14+ yrs
Sex: All
Sponsor: Boston Children's Hospital
Primary completion: Jul 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.	0.031; 0.028	—
PRIMARY Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.	15; 20; 4; 5.5; 6.5; 0	—
SECONDARY End-tidal CO2	33.4; 33.2	—
SECONDARY Heart Rate	162.5; 164.5; 171.1; 170; 170.2; 167.4	—
SECONDARY Volume of Self-reported Exercise Per Week	115; 88	—
SECONDARY Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.	15.8; 15.4; 16.7; 15.5; 16.7; 15.1	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT03170856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.