Creatine Supplementation in Concussion Recovery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Creatine.
- Кому может быть актуально
- Состояния в реестре: Concussion, Brain. Базовые параметры: 18 лет — 35 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Assigned Creatine Ingestion With Usual Diet or Usual Diet Alone.
Обзор
The proposed study aims to compare concussion recovery in those supplementing creatine and those not supplementing creatine. Specific aim 1: To compare number of days until asymptomatic between those taking creatine vs. those not taking creatine following a concussion. Hypothesis: The investigators hypothesize that individuals taking creatine will become asymptomatic sooner than those not taking creatine.Specific aim 2: To compare typical concussion assessment scores (i.e., symptom score, mental status, neurocognition, balance, motor coordination, and visual performance) between those taking creatine vs those not taking creatine following a concussion once asymptomatic.Hypothesis: The investigators hypothesize that individuals taking creatine will have better symptom scores, balance, mental status, and neurocognition assessment scores than those not taking creatine once asymptomatic. The investigators will calculate descriptive statistics for all demographic, days to asymptomatic, and concussion assessments. For specific aim 1, The investigators will calculate a t-test to determine if days to asymptomatic differed in those taking creatine vs. those not taking creatine. For specific aim 2, the investigators will calculate t-tests with Bonferonni corrections to determine if concussion assessment scores (Sport Concussion Office Assessment Tool-6 assessments, CNS Vital Signs, visual assessment) differed in those taking creatine vs. those not taking creatine.
Подробное описание
Our proposed study aims to compare concussion recovery in those supplementing creatine and those not supplementing creatine. Specific aim 1: To compare number of days until asymptomatic between those taking creatine vs. those not taking creatine following a concussion. Hypothesis: The investigators hypothesize that individuals taking creatine will become asymptomatic sooner than those not taking creatine. Specific aim 2: To compare typical concussion assessment scores (i.e., symptom score, mental status, neurocognition, balance, motor coordination, and visual performance) between those taking creatine vs those not taking creatine following a concussion once asymptomatic. Hypothesis: The investigators hypothesize that individuals taking creatine will have better symptom scores, balance, mental status, and neurocognition assessment scores than those not taking creatine once asymptomatic.
Once the research team is contacted about a potential injury, the investigators will ensure the participant meets inclusion criteria prior to meeting and schedule a meeting if meet inclusion criteria to explain study details, obtain informed consent, administer a symptom checklist (Sport Concussion Office Assessment Tool-5, SCOAT-6) and demographic questionnaire, and provide creatine. The investigators will use the following components of the SCAOT-6: Removal from play and description, (Current Injury; p. 652), Symptom Evaluation (p. 654-655), Verbal Cognitive Tests (p. 655), Digits Backwards (p. 656), Months in Reverse (p. 656), Orthostatic Vital Signs (p.657), Balance (p. 658), Timed Tandem Gait (p. 658), Complex Tandem Gait (p. 659), Dual Task Gait (p.659), Modified Vestibular/Ocular-Motor Screen (p. 660), Anxiety Screen (p. 660), Depression Screen (p. 660), sleep screen (p. 661), Delayed Word Recall (p. 662) (requires approximately 1 hour). Participants will be randomly assigned to the intervention or control group (10 participants targeted for each group; participant identification numbers will be predetermined and allocated once enrolled). The intervention group will consume their usual diet plus 5 grams of creatine for the first four days following the initial meeting, and then 3 grams of creatine once per day thereafter until asymptomatic. The control group will be asked to consume their usual diet and no creatine. The investigators will then remain in contact with the participant to ensure compliance, and assess when the participant is asymptomatic. When the investigators contact the participant will vary depending on recovery process (e.g., if a participant has high symptom burden, they may allow a few days between contact; whereas if a participant is nearing asymptomatic, they contact the participant more frequently).
Once the participant becomes asymptomatic, the investigators will meet to administer a SCAOT-6, a computerized neurocognitive assessment (CNS Vital Signs), visual assessment (King-Devick) and note days from injury to asymptomatic. CNS Vital Signs requires approximately 20-25 minutes and assesses the domains of verbal and visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, simple attention, and motor speed. King-Devick is a visual assessment asking participants to read three test cards with numbers as fast as possible without committing errors. The investigators anticipate the assessment requiring approximately 1.5 hours.
The investigators will calculate descriptive statistics for all demographic, days to asymptomatic, and concussion assessments. For specific aim 1, the investigators will calculate a t-test to determine if days to asymptomatic differed in those taking creatine vs. those not taking creatine. For specific aim 2, the investigators will calculate t-tests with Bonferonni corrections to determine if concussion assessment scores (SCOAT-6 assessments, CNS Vital Signs, visual assessment) differed in those taking creatine vs. those not taking creatine.
Вмешательства
- Пищевая добавка Creatine
Creatine supplementation
Первичные конечные точки
- Days to asymptomatic [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
Вторичные конечные точки (12)
- Symptom evaluation - Sport Concussion Office Assessment Tool 6 [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Standardized Assessment of Concussion - Sport Concussion Office Assessment Tool 6 [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6 [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6 [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Balance Error Scoring System - Sport Concussion Office Assessment Tool 6 [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Timed Tandem Gait - Sport Concussion Office Assessment Tool 6 [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Complex Tandem Gait - Sport Concussion Office Assessment Tool 6 [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Dual Task Gait Cognitive Accuracy Score - Sport Concussion Office Assessment Tool 6 [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Dual Task Gait Average Time - Sport Concussion Office Assessment Tool 6 [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Vestibular/Ocular-Motor Screening Smooth Pursuits [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Vestibular/Ocular-Motor Screening Saccades Horizontal [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
- Vestibular/Ocular-Motor Screening Saccades Vertical [Срок оценки: From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks]
Критерии участия
Критерии включения
- 18-35 years old with a diagnosed concussion within 72 hours post-injury
Критерии исключения
- Learning disability, renal disease, mental behavior or migraine history, and current creatine use or have not taken creatine in the past 6 weeks
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- San Diego State University — San Diego
Публикации
- Roschel H, Gualano B, Ostojic SM, Rawson ES. Creatine Supplementation and Brain Health. Nutrients. 2021 Feb 10;13(2):586. doi: 10.3390/nu13020586. PMID 33578876
- Broglio SP, Cantu RC, Gioia GA, Guskiewicz KM, Kutcher J, Palm M, Valovich McLeod TC; National Athletic Trainer's Association. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014 Mar-Apr;49(2):245-65. doi: 10.4085/1062-6050-49.1.07. Epub 2014 Mar 7. PMID 24601910
- Giza CC, Hovda DA. The new neurometabolic cascade of concussion. Neurosurgery. 2014 Oct;75 Suppl 4(0 4):S24-33. doi: 10.1227/NEU.0000000000000505. PMID 25232881
- Harmon KG, Clugston JR, Dec K, Hainline B, Herring S, Kane SF, Kontos AP, Leddy JJ, McCrea M, Poddar SK, Putukian M, Wilson JC, Roberts WO. American Medical Society for Sports Medicine position statement on concussion in sport. Br J Sports Med. 2019 Feb;53(4):213-225. doi: 10.1136/bjsports-2018-100338. PMID 30705232
Идентификаторы
NCT: NCT06208813 · Temp-4061