Brain Concussion, Healthy, Sport-related Concussion
Conditions
Keywords
Concussion, Contact sport, Collision sport, Neck strengthening, Soccer, Head Acceleration
Brief summary
Sport-related concussion is a common and serious injury that can affect athletes of all ages in any sport. The purpose of this project is to study the effect of a 12-week manual resistance neck strengthening exercise program on participants' neck size and strength and how their heads and necks move during simulated sport-associated tasks. This study will help determine if greater neck strength may lower an athlete's risk of sport-related concussion. Each healthy male and female soccer athlete between the ages of 13-19 enrolled in the study will participate for approximately four months. Study participation includes routine visits with various assessments (i.e. certain body measurements, magnetic resonance imaging, ultrasound) in addition to the strengthening exercise program.
Detailed description
This study was updated to remove the low-volume group and the amendment was approved 3/29/2023 at the Institutional Review Board. This change to remove the low-volume exercise group was due to reduced enrollment numbers following the Corona Virus Disease (COVID) Pandemic.
Interventions
OTHERhigh-intensity neck strengthening
All subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions. Participants will perform a standardized set of general resistance exercises targeting the chest, shoulders, back, upper and lower extremities, and core. Additionally, they will also perform a higher number of repetitions of manual resistance neck strengthening exercises in sagittal plane flexion and extension, coronal plane lateral flexion in both directions, and axial plane rotation in both directions,as well as dumbbell shoulder shrugs.
OTHERControl group
All subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions. Participants will perform a standardized set of general resistance exercises targeting only the chest, shoulders, back, upper and lower extremities, and core, without resistance exercises specifically targeting the neck.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Neither subjects nor the study team members responsible for performing the laboratory- or radiology-based assessment will be informed of group allocation status, although subjects will be aware of whether or not they are performing neck strengthening exercises during their exercise sessions. Subjects will be instructed not to reveal their group status during subsequent assessment sessions.
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed and dated informed consent form, or assent form with parental consent for minors * Stated willingness to comply with all study procedures and availability for the duration of the study * Participated in a soccer team, club, or other soccer program/organization within the preceding 2 years * Be willing to adhere to the assigned exercise regimen
Exclusion criteria
* Prior history of trauma-induced neck injury of sufficient severity to require treatment by a medical provider within 30 days of injury or to limit sport participation for \> 1 day (note: having received routine chiropractic treatment in the absence of a recent traumatic injury to the neck will not be considered to meet this criterion) * Any prior history of whiplash injury, stinger/burner, or cervical radiculopathy diagnosed by a medical provider * Any prior history of bone, disk, neural, or ligamentous abnormality identified on cervical spine medical imaging performed for any reason that is felt by the PI (or designee) to present a risk to study participation * Any prior history of surgery involving the cervical spine (note: having undergone non-spine surgery to the soft tissue structures in the neck will not necessarily exclude participation, but will be considered on a case-by-case basis by the PI, or his designee, with consultation from the performing surgeon when deemed appropriate) * Self-report of moderate or severe neck pain (rated as 5 or greater on a 10-point pain scale) lasting \> 1 day in the previous 6 months that required any evaluation or treatment by a medical provider or that limited sport participation for \> 1 day (note: having received routine chiropractic treatment in the absence of moderate-severe neck pain will not be considered to meet this criterion) * Self-report of low back pain (any severity) associated with morning stiffness occurring 30 days or more in the previous 3 months. * Prior episode(s) of unexplained upper extremity numbness, tingling, or weakness suspicious to the PI, or designee, for a stinger/burner or cervical radiculopathy in the last 3 years * Prior history of concussion in the previous 6 months diagnosed by a medical provider or suspected by the subject, or the parent/guardian of a minor (if no medical evaluation was sought), or any diagnosed/suspected concussion without full recovery and clearance to resume unrestricted sport participation. * Personal history of migraine headaches within the previous 3 years diagnosed by a medical provider, with one or more headache episodes, or requiring treatment. * Personal history of anxiety disorder diagnosed by a medical provider that has either been difficult to control, affected daily function, or required treatment with medication or counseling within the previous 3 years. * Parental/guardian known history of anxiety disorder diagnosed by a medical provider that has either been difficult to control, affected daily function, or required treatment with medication or counseling within the previous 3 years. * Prior personal of any of the following or known family history of the following medical conditions known to be associated with atlanto-axial instability diagnosed by a medical provider: parental history of Down Syndrome, Ehlers-Danlos Syndrome, or Marfan syndrome; parental, or sibling history of rheumatoid arthritis/other systemic inflammatory disease with joint involvement or mucopolysaccharidosis * Known exposure to or infection with head lice in the previous 30 days * Known or suspected pregnancy (for females) * Serious allergic reaction to nickel/metal jewelry * Any contraindication to MRI scanning * Presence of significant abnormality on a standardized screening neurological and musculoskeletal physical examination * Prior participation in a resistance exercise training program including exercises specifically intended to target the neck muscles within 3 months of enrollment, or intention to begin participating in such an exercise program outside of the study protocol during the upcoming 12-week study period * Unable to speak and understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. | 4 weeks, 8 weeks, 12 weeks | The linear component of head acceleration was measured with a sensor attached to the head, while a device applied force to the head. The data is reported where higher values represent greater acceleration per amount of force delivered (zero represents no acceleration and greater numbers higher acceleration). |
| Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion. | 4 weeks, 8 weeks, 12 weeks | The angular component of head acceleration was measured with a sensor attached to the head, while a device applied force to the head. The data is reported where higher values represent greater acceleration per amount of force delivered (zero represents no acceleration and greater numbers higher acceleration). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion. | 4 weeks, 8 weeks, 12 weeks | The linear component of head acceleration was measured with a sensor attached to the head, while a simulated body check was administered. The data is reported where higher values represent greater acceleration (zero represents no acceleration and greater numbers higher acceleration). |
| Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion. | 4 weeks, 8 weeks, 12 weeks | The angular component of head acceleration was measured with a sensor attached to the head, while a simulated body check was administered. The data is reported where higher values represent greater acceleration (zero represents no acceleration and greater numbers higher acceleration). |
Countries
United States
Participant flow
Pre-assignment details
Enrollment indicates participants who consented. Prior to randomization 5 participants were lost (2 withdrew, 2 lost to follow-up and 1 no longer eligible).
Participants by arm
| Arm | Count |
|---|---|
| High-intensity Neck Strengthening Group high-intensity neck strengthening: All subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions.
Participants will perform a standardized set of general resistance exercises targeting the chest, shoulders, back, upper and lower extremities, and core. Additionally, they will also perform a higher number of repetitions of manual resistance neck strengthening exercises in sagittal plane flexion and extension, coronal plane lateral flexion in both directions, and axial plane rotation in both directions,as well as dumbbell shoulder shrugs. | 19 |
| Control Group Control group: All subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions.
Participants will perform a standardized set of general resistance exercises targeting only the chest, shoulders, back, upper and lower extremities, and core, without resistance exercises specifically targeting the neck. | 24 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | High-intensity Neck Strengthening Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 15.11 years STANDARD_DEVIATION 1.1 | 15.47 years STANDARD_DEVIATION 1.39 | 15.75 years STANDARD_DEVIATION 1.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 38 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 34 Participants | 19 Participants |
| Region of Enrollment United States | 19 Participants | 43 Participants | 24 Participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 27 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 19 |
| other Total, other adverse events | 15 / 24 | 11 / 19 |
| serious Total, serious adverse events | 1 / 24 | 1 / 19 |
Outcome results
Primary
Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion.
The angular component of head acceleration was measured with a sensor attached to the head, while a device applied force to the head. The data is reported where higher values represent greater acceleration per amount of force delivered (zero represents no acceleration and greater numbers higher acceleration).
Time frame: 4 weeks, 8 weeks, 12 weeks
Population: For the high-intensity group 3 subjects withdrew from follow-up visit 1 to Follow-Up Visit 3. For the control group 4 subjects withdrew from the baseline visit to follow-up visit 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion. | Baseline | .057 radians per second per joule | Standard Deviation 0.04 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 1 (4 weeks) | .054 radians per second per joule | Standard Deviation 0.036 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 2 (8 weeks) | .056 radians per second per joule | Standard Deviation 0.037 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 3 (12 weeks) | .05 radians per second per joule | Standard Deviation 0.039 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 3 (12 weeks) | .049 radians per second per joule | Standard Deviation 0.035 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion. | Baseline | .069 radians per second per joule | Standard Deviation 0.047 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 2 (8 weeks) | .063 radians per second per joule | Standard Deviation 0.039 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 1 (4 weeks) | .058 radians per second per joule | Standard Deviation 0.043 |
Primary
Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion.
The linear component of head acceleration was measured with a sensor attached to the head, while a device applied force to the head. The data is reported where higher values represent greater acceleration per amount of force delivered (zero represents no acceleration and greater numbers higher acceleration).
Time frame: 4 weeks, 8 weeks, 12 weeks
Population: For the high-intensity group 3 subjects withdrew from follow-up visit 1 to Follow-Up Visit 3. For the control group 4 subjects withdrew from the baseline visit to follow-up visit 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. | Baseline | .895 meters per second per joule | Standard Deviation 0.378 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 1 (4 weeks) | .873 meters per second per joule | Standard Deviation 0.398 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 2 (8 weeks) | .893 meters per second per joule | Standard Deviation 0.44 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 3 (12 weeks) | .839 meters per second per joule | Standard Deviation 0.392 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 3 (12 weeks) | .793 meters per second per joule | Standard Deviation 0.386 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. | Baseline | 1.069 meters per second per joule | Standard Deviation 0.501 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 2 (8 weeks) | .937 meters per second per joule | Standard Deviation 0.404 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Direct Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 1 (4 weeks) | .903 meters per second per joule | Standard Deviation 0.491 |
Secondary
Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion.
The angular component of head acceleration was measured with a sensor attached to the head, while a simulated body check was administered. The data is reported where higher values represent greater acceleration (zero represents no acceleration and greater numbers higher acceleration).
Time frame: 4 weeks, 8 weeks, 12 weeks
Population: For the high-intensity group 3 subjects withdrew from follow-up visit 1 to Follow-Up Visit 3. For the control group 4 subjects withdrew from the baseline visit to follow-up visit 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion. | Baseline | 0.020 radians per second | Standard Deviation 0.01 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 1 (4 weeks) | 0.02 radians per second | Standard Deviation 0.011 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 2 (8 weeks) | 0.02 radians per second | Standard Deviation 0.008 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 3 (12 weeks) | 0.019 radians per second | Standard Deviation 0.009 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 3 (12 weeks) | 0.019 radians per second | Standard Deviation 0.009 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion. | Baseline | 0.020 radians per second | Standard Deviation 0.008 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 2 (8 weeks) | 0.019 radians per second | Standard Deviation 0.008 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Angular Motion. | Follow-Up Visit 1 (4 weeks) | 0.018 radians per second | Standard Deviation 0.01 |
Secondary
Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion.
The linear component of head acceleration was measured with a sensor attached to the head, while a simulated body check was administered. The data is reported where higher values represent greater acceleration (zero represents no acceleration and greater numbers higher acceleration).
Time frame: 4 weeks, 8 weeks, 12 weeks
Population: For the high-intensity group 3 subjects withdrew from follow-up visit 1 to Follow-Up Visit 3. For the control group 4 subjects withdrew from the baseline visit to follow-up visit 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion. | Baseline | 1.007 meters per second | Standard Deviation 0.417 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 1 (4 weeks) | 1.007 meters per second | Standard Deviation 0.418 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 2 (8 weeks) | 0.999 meters per second | Standard Deviation 0.367 |
| High-intensity Neck Strengthening Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 3 (12 weeks) | 0.938 meters per second | Standard Deviation 0.367 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 3 (12 weeks) | 1.007 meters per second | Standard Deviation 0.397 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion. | Baseline | 1.105 meters per second | Standard Deviation 0.432 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 2 (8 weeks) | 0.973 meters per second | Standard Deviation 0.323 |
| Control Group | Mean Area Under the Net Head Acceleration vs. Time Curve During Indirect Loading, With Anticipatory Bracing - Linear Motion. | Follow-Up Visit 1 (4 weeks) | 0.943 meters per second | Standard Deviation 0.403 |