Trial Outcomes & Findings for Salivary Biomarkers for Concussion Recovery (NCT NCT05379920)
NCT ID: NCT05379920
Last Updated: 2024-01-03
Results Overview
PPCS is defined as more recovery that occurs 28 days or more from the day of concussive injury (yes) or before 28 days (no). Recovery is defined as asymptomatic, exercise tolerant and confirmation by independent medical examination.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
28 days
Results posted on
2024-01-03
Participant Flow
Participants were recruited during the 1-year study beginning in 2022 from the UBMD Concussion Clinic. 32 concussed adolescents met inclusion criteria and were willing to participate in the study. Within the same time frame, 28 healthy adolescents were willing to participate in the study.
Participant milestones
| Measure |
Concussed Participants Group 1
High Volume Group
High Volume Aerobic Exercise: Aerobic exercise is completed for 30 minutes, 5 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Concussed Participants Group 2
Low Volume Group
Low Volume Aerobic Exercise: Aerobic exercise is completed for 20 minutes, 3 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Healthy Controls Group 1
High Volume Group
High Volume Aerobic Exercise: Aerobic exercise is completed for 30 minutes, 5 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Healthy Controls Group 2
Low Volume Group
Low Volume Aerobic Exercise: Aerobic exercise is completed for 20 minutes, 3 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
15
|
13
|
|
Overall Study
COMPLETED
|
17
|
10
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
Concussed Participants Group 1
High Volume Group
High Volume Aerobic Exercise: Aerobic exercise is completed for 30 minutes, 5 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Concussed Participants Group 2
Low Volume Group
Low Volume Aerobic Exercise: Aerobic exercise is completed for 20 minutes, 3 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Healthy Controls Group 1
High Volume Group
High Volume Aerobic Exercise: Aerobic exercise is completed for 30 minutes, 5 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Healthy Controls Group 2
Low Volume Group
Low Volume Aerobic Exercise: Aerobic exercise is completed for 20 minutes, 3 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
0
|
0
|
Baseline Characteristics
Salivary Biomarkers for Concussion Recovery
Baseline characteristics by cohort
| Measure |
Concussed Participants Group 1
n=17 Participants
High Volume Group
High Volume Aerobic Exercise: Aerobic exercise is completed for 30 minutes, 5 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Concussed Participants Group 2
n=15 Participants
Low Volume Group
Low Volume Aerobic Exercise: Aerobic exercise is completed for 20 minutes, 3 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Healthy Controls Group 1
n=15 Participants
High Volume Group
High Volume Aerobic Exercise: Aerobic exercise is completed for 30 minutes, 5 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Healthy Controls Group 2
n=13 Participants
Low Volume Group
Low Volume Aerobic Exercise: Aerobic exercise is completed for 20 minutes, 3 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5. Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
13 participants
n=4 Participants
|
60 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 daysPPCS is defined as more recovery that occurs 28 days or more from the day of concussive injury (yes) or before 28 days (no). Recovery is defined as asymptomatic, exercise tolerant and confirmation by independent medical examination.
Outcome measures
| Measure |
Concussed Participants Group 1
n=17 Participants
High Volume Group
High Volume Aerobic Exercise: Aerobic exercise is completed for 30 minutes, 5 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
Concussed Participants Group 2
n=15 Participants
Low Volume Group
Low Volume Aerobic Exercise: Aerobic exercise is completed for 20 minutes, 3 days a week. Exercise intensity is adjusted weekly to 90% of the heart rate threshold. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT.
|
|---|---|---|
|
Persistent Post Concussion Symptoms (PPCS) (Yes/No)
|
4 Participants
|
4 Participants
|
Adverse Events
Concussed Participants Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Concussed Participants Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls Group 2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place