The Efficacy of an Aerobic Exercise and Cognitive Training Program on Postconcussive Symptomology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- The Rivermead Post Concussion Symptoms Questionnaire
研究概览
简要总结
The purpose of this study is to compare a 4-week, moderately intensive, lab and home-based aerobic exercise program versus exercise plus cognitive training. Participants will include individuals who experience lingering symptoms of a head injury or concussion.
详细描述
Eligible participants will engage in 30 minute bouts of aerobic exercise three times per week followed by a 20-minute post-exercise activity. Randomization will place participants into one of three groups: (1) aerobic exercise + cognitive training, (2) aerobic exercise + videos, or (3) waitlist control. Post-exercise activities will be delivered via participants' smartphone device by downloading the appropriate cognitive training platform or online video link.
Baseline and post-intervention assessments will consist of symptom reporting, cognitive measures, and psychosocial questionnaires. Physiological measures including heart rate and blood pressure will be assessed at baseline and at follow-up as well as during each in-lab exercise session. The wait-list control group is asked to complete all baseline and follow-up assessments and resume normal activity during the four weeks. The first week of exercise will take place in a lab-based environment, while weeks 2-4 will take place outside of the lab (participants must have access to exercise equipment at home or local fitness facility).
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have history of at least one concussion (onset was at age 18 or later)
- •Ability to exercise at moderate to vigorous activity levels (defined as 50%-75% of the adjusted age-predicted maximum heart rate)
- •Experiencing persistent symptoms (persistent defined as, most days per week for at least 2 weeks since sustaining injury) resulting from concussion or head injury
- •Access to a smartphone and willingness to allow research staff to install application (and space to allow for installation)
- •Access to a treadmill to complete exercise outside of lab environment
- •Willingness to provide proof of concussion or head injury medical diagnosis
- •Willingness to provide contact information of individual to confirm persistent symptoms if medical diagnosis is unavailable
- •Willingness to be randomized into one of three groups
排除标准
- •No history of concussion, head injury, or mild traumatic brain injury
- •Experiencing less than 3 persistent symptoms (persistent defined as, most days per week for at least 2 weeks since sustaining injury)
- •No access to a smartphone
- •No access to a treadmill
- •Too active (as defined by regular exercise most days per week for 30+ minutes over the past 3 months)
- •Unable or unwilling to comply to lab and home-based exercise prescription
- •Unable or unwilling to commit to full length of program
- •Incapable of performing moderately intensive aerobic exercise OR sustaining attention to screen for 20 minutes
- •Unwilling to be randomized to one of 3 groups
- •Unable to commute to and from UIUC campus
- •Already involved in regular weekly physical activity or cognitive training program
- •Had previously diagnosed mental health condition (e.g., Major Depressive Disorder, Generalized Anxiety Disorder)
- •Current involvement in litigation specific to injury
研究组 & 干预措施
Exercise+CT
Aerobic exercise for 30 minutes and smart-phone delivered cognitive training application for 20 minutes, 3 times per week for 4 weeks
干预措施: Exercise+CT (Behavioral)
Exercise only
Aerobic exercise for 30 minutes and smart-phone delivered videos for 20 minutes, 3 times per week for 4 weeks
干预措施: Exercise only (Behavioral)
结局指标
主要结局
The Rivermead Post Concussion Symptoms Questionnaire
时间窗: Assessed at baseline and at 1-month follow-up
Self reported symptoms following a head injury. Each of the 16 symptom items (e.g., sleep disturbance) is scored 0-4 (0=not experienced at all; 1=no more of a problem; 2=a mild problem; 3=a moderate problem; 4=a severe problem), yielding a total between 0 and 64. We are targeting change in total symptoms but because of the problems with "change scores" our operational definition of successful change in the primary outcome will be the time 2 total score (1-month follow-up) regressed on group while statistically adjusting for baseline score.
次要结局
- NIH Toolbox Cognition Battery - Working Memory(Assessed at baseline and at 1-month follow-up)
- NIH Toolbox Cognition Battery - Attention(Assessed at baseline and at 1-month follow-up)
研究者
Sean Mullen
Associate Professor
University of Illinois at Urbana-Champaign