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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD093733-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-intensity neck strengthening group | Experimental |
| |
| Control group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-intensity neck strengthening | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 weeks, 8 weeks, 12 weeks |
| 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). | 4 weeks, 8 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James T Eckner, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine | Ann Arbor | Michigan | 48108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29557889 | Background | Eckner JT, Goshtasbi A, Curtis K, Kapshai A, Myyra E, Franco LM, Favre M, Jacobson JA, Ashton-Miller JA. Feasibility and Effect of Cervical Resistance Training on Head Kinematics in Youth Athletes: A Pilot Study. Am J Phys Med Rehabil. 2018 Apr;97(4):292-297. doi: 10.1097/PHM.0000000000000843. | |
| 24488820 | Background | Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31. |
| Label | URL |
|---|---|
| Related Info | View source |
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Enrollment indicates participants who consented. Prior to randomization 5 participants were lost (2 withdrew, 2 lost to follow-up and 1 no longer eligible).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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). | 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. | Posted | Mean | Standard Deviation | meters per second per joule | 4 weeks, 8 weeks, 12 weeks |
|
Up to four months
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Nausea requiring ER visit, but not hospital admittance. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James T Eckner, MD, MS | University of Michigan Medical School | 734-647-5568 | jeckner@med.umich.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 | Jun 16, 2023 | May 14, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2023 | May 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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.
|
| Control group | Other | 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. |
|
| 4 weeks, 8 weeks, 12 weeks |
| 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). | 4 weeks, 8 weeks, 12 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | radians per second per joule | 4 weeks, 8 weeks, 12 weeks |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | meters per second | 4 weeks, 8 weeks, 12 weeks |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | radians per second | 4 weeks, 8 weeks, 12 weeks |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| 15 |
| 24 |
| EG001 | 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. | 0 | 19 | 1 | 19 | 11 | 19 |
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| vomiting | Gastrointestinal disorders | Systematic Assessment | Vomiting requiring ER visit, but not hospital admittance. |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea requiring ER visit, but not hospital admittance. |
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| conjunctivitis | Eye disorders | Systematic Assessment | Conjunctivitis requiring ER visit, but not hospital admittance. |
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| Minor hand injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Wisdom teeth removal surgery | Surgical and medical procedures | Systematic Assessment |
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| Sore throat | General disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Calf cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bilateral nerve pain in arms | Nervous system disorders | Systematic Assessment |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Ankle injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cold/flu symptoms | Infections and infestations | Systematic Assessment |
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| Hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| COVID | Infections and infestations | Systematic Assessment |
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| Knee discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back spasms | General disorders | Systematic Assessment |
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| Fatigue after extensive exertion | General disorders | Systematic Assessment |
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| Neck pain | General disorders | Systematic Assessment |
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| Knee injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Toe injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Suspected concussion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Confirmed concussion | Injury, poisoning and procedural complications | Systematic Assessment |
|
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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 |
| D008722 | Methods |
| Follow-Up Visit 1 (4 weeks) |
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| Follow-Up Visit 2 (8 weeks) |
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| Follow-Up Visit 3 (12 weeks) |
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| Follow-Up Visit 1 (4 weeks) |
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| Follow-Up Visit 2 (8 weeks) |
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| Follow-Up Visit 3 (12 weeks) |
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| Follow-Up Visit 1 (4 weeks) |
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| Follow-Up Visit 2 (8 weeks) |
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| Follow-Up Visit 3 (12 weeks) |
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