Trial Outcomes & Findings for Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion (NCT NCT02710123)

NCT ID: NCT02710123

Last Updated: 2025-10-15

Results Overview

Time (in days) to recovery (Recovery is asymptomatic+able to exercise to exhaustion without symptom exacerbation+judged recovered by MD with structured physical exam.)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 113 participants
• Primary outcome timeframe: 2 to 180 days
• Results posted on: 2025-10-15

Participant Flow

Out of 165 eligible candidates, 113 were randomized, 10 were lost to follow-up and 103 were included in the analysis.

Participant milestones

Measure	Aerobic Exercise Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription	Stretching Exercise Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription.
Overall Study STARTED	57	56
Overall Study COMPLETED	52	51
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Aerobic Exercise Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription	Stretching Exercise Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription.
Overall Study Lost to Follow-up	3	4
Overall Study Withdrawal by Subject	1	1
Overall Study Illness unrelated to study intervention	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Aerobic Exercise n=57 Participants Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription	Stretching Exercise n=56 Participants Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription.	Total n=113 Participants Total of all reporting groups
Age, Continuous	15.3 Years STANDARD_DEVIATION 1.6 • n=57 Participants	15.4 Years STANDARD_DEVIATION 1.7 • n=56 Participants	15.3 Years STANDARD_DEVIATION 1.6 • n=113 Participants
Sex: Female, Male Female	26 Participants n=57 Participants	26 Participants n=56 Participants	52 Participants n=113 Participants
Sex: Female, Male Male	31 Participants n=57 Participants	30 Participants n=56 Participants	61 Participants n=113 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	57 Participants n=57 Participants	56 Participants n=56 Participants	113 Participants n=113 Participants
Time since injury	4.9 Days STANDARD_DEVIATION 2.2 • n=57 Participants	4.8 Days STANDARD_DEVIATION 2.4 • n=56 Participants	4.9 Days STANDARD_DEVIATION 2.3 • n=113 Participants

PRIMARY outcome

Timeframe: 2 to 180 days

Time (in days) to recovery (Recovery is asymptomatic+able to exercise to exhaustion without symptom exacerbation+judged recovered by MD with structured physical exam.)

Outcome measures

Measure	Aerobic Exercise n=52 Participants Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription	Stretching Exercise n=51 Participants Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription.
Time (in Days) to Recovery	13 Days Interval 10.0 to 18.5	17 Days Interval 13.0 to 23.0

Adverse Events

Aerobic Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stretching Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Leddy MD

SUNY Buffalo

Phone: 7162043200

Email: leddy@buffalo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place