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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001412 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The overarching purpose of this proposed research is to determine whether BDNF and/or specific miRNAs can serve as biomarkers for recovery from a concussion during prescribed exercise. The investigators hypothesize salivary BDNF and specific miRNA signatures will change in a statistically significant manner as participants proceed from injury to recovery and participants who show recovery in ANS regulation will show significant differences in salivary BDNF and specific miRNA expression. This study also aims to determine if BDNF and/or specific miRNA can serve as biomarkers of the return of ANS function in concussed patients. The basic premise here is that the volume of exercise will significantly affect the rate of change in the expression of salivary BDNF and miRNA from injury to recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concussed Participants Group 1 | Experimental | High Volume Group |
|
| Concussed Participants Group 2 | Experimental | Low Volume Group |
|
| Healthy controls Group 1 | Active Comparator | High Volume Group |
|
| Healthy Controls Group 2 | Active Comparator | Low Volume Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Volume Aerobic Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent Post Concussion Symptoms (PPCS) (Yes/No) | 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. | 28 days |
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Inclusion Criteria:
• Adolescent and adult athletes (age 13-18) diagnosed with SRC within 10 days of injury.
Exclusion Criteria:
Self-representation of gender identity
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| Name | Affiliation | Role |
|---|---|---|
| John Leddy, MD | University at Buffalo | Study Director |
| Barry Willer, PhD | University at Buffalo | Study Chair |
| Praveen Arany, DDS, PhD | University at Buffalo | Principal Investigator |
| Mohammad Nadir, MD, PhD | University at Buffalo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UB MD Orthopeadics & Sports Medicine | Buffalo | New York | 14214 | United States |
No plan to share IPD currently
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
It is hypothesized that participants in the concussion group would not different in age, sex, ethnicity, height or weight from control samples.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age Range in Years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Persistent Post Concussion Symptoms (PPCS) (Yes/No) | 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. | Posted | Count of Participants | Participants | 28 days |
|
Adverse events were monitored during the two week intervention.
Adolescents participant condition (concussed or healthy) and intervention (light aerobic exercise) does not constitute a high risk for serious adverse events or mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haley Chizuk | University at Buffalo | 7162043200 | 2188 | haleychi@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2023 | Dec 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Participants will be randomly assigned into 4-arms: (1) Concussed participants: high volume exercise, (2) Concussed participants: low volume exercise, (3) Healthy controls: high volume exercise, (4) Healthy controls: low volume exercise. Each group will consist of 50% males and 50% females. Exercise interventions for all participants are adjusted to the 90% Heart rate threshold (HRt) collected on the BCTT. The high-volume group will exercise aerobically at 90% of their HRt for 5 days a week for 30 minutes. The low volume group will exercise aerobically at 90% of their HRt for 3 days a week for 30 minutes. The intervention will last 2 weeks. Participants will return to the clinic and repeat testing on Days 7 and 14. Recovery is defined as (1) resolution of concussion symptoms (2) physical examination within normal limits; (3) ability to exercise to at least 80% of age-appropriate maximum HR without exacerbation of concussion-like symptoms on the BCTT.
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|
| Low Volume Aerobic Exercise | Behavioral | 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. |
|
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Binary sex as determined at birth | Count of Participants | Participants |
|
| Race (NIH/OMB) | Racial ethnic group | Count of Participants | Participants |
|
| Region of Enrollment | Geographical location of discrete groups | Number | 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.
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D001519 | Behavior |