Assigned Creatine Ingestion With Usual Diet or Usual Diet Alone.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Days to asymptomatic
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-35 years old with a diagnosed concussion within 72 hours post-injury
排除标准
- •Learning disability, renal disease, mental behavior or migraine history, and current creatine use or have not taken creatine in the past 6 weeks
研究组 & 干预措施
Creatine supplementation
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.
干预措施: Creatine (Dietary Supplement)
Control Group
Participants will consume their normal daily diet.
结局指标
主要结局
Days to asymptomatic
时间窗: 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
Days to asymptomatic
次要结局
- Complex Tandem Gait - Sport Concussion Office Assessment Tool 6(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(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)
- Reaction time - CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Cognitive Flexibility- CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Standardized Assessment of Concussion - Sport Concussion Office Assessment Tool 6(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(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(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(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(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)
- Visual memory - CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Symptom evaluation - Sport Concussion Office Assessment Tool 6(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 Convergence(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)
- Anxiety Screen - Sport Concussion Office Assessment Tool 6(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)
- Depression Screen - Sport Concussion Office Assessment Tool 6(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)
- Sleep Screen - Sport Concussion Office Assessment Tool 6(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 attention - CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Processing speed - CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Timed Tandem Gait - Sport Concussion Office Assessment Tool 6(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(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 Vestibular-Ocular Reflex Vertical(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)
- Verbal memory - CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Vestibular/Ocular-Motor Screening Vestibular-Ocular Reflex Horizontal(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 Visual Motion Sensitivity Test(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)
- Psychomotor speed - CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Executive function - CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Simple Attention - CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Motor Speed - CNS Vital Signs(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- King-Devick Visual Assessment(Will be measured once at the asymptomatic timepoint; From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, no more than 100 weeks after injury)
- Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6(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)