Treatment Optimization of Brain-injured Warfighters: A Prescribed Sub-symptomatic Exercise Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Neurobehavioral Symptom Change
研究概览
简要总结
Prescribed sub-symptomatic adaptable exercise treatment (SAET) is a potential solution that promotes recovery needs following a TBI. SAET has been shown to benefit the mind and body in ways that decrease the severity and frequency of mild TBI (mTBI) symptoms. This study aims to validate SAET as an alternative, adaptable treatment or SMs with mTBI that focuses on reducing symptoms, improving mental health, increasing physiological functioning, and ultimately returning to duty.
The objective of this study is to develop a prescribed exercise treatment program for warfighters with mTBI that can be personalized for SM's needs (i.e., medical and occupational) and is adaptable to various clinical resources (e.g., forward operating bases, rural clinics, and mTBI specialty programs). The key question raised by this study is whether SAET is more effective than a stretching control group (SCG) in reducing neurobehavioral symptoms among SMs with persistent complaints following a mTBI.
详细描述
The study will be a randomized clinical trial among active duty service members (SMs) with persistent cognitive complaints following mTBI, comparing a prescribed sub-symptomatic adaptable exercise treatment (SAET) to an active stretching control group (SCG). SAET's overall effectiveness will be assessed by neurobehavioral symptom resolution. Additional exploratory aims will include cognitive performance, physiological adaptation and locomotion as well as functional changes in military performance. These items will be addressed in the following aims.
Primary Aim:
To determine whether SAET is more effective than the control condition in reducing neurobehavioral symptoms among SMs with persistent complaints following mTBI. Hypothesis 1: There will be a greater reduction in the Neurobehavioral Symptoms Inventory (NSI) from pre- to post-SAET compared to the control condition. A similar finding will continue from immediate to 3 month post-SAET.
Secondary Aims:
Sub-aim 1 Cognitive Status: To determine if SAET is effective at improving cognitive impairment among SMs with persistent complaints from mTBI. Sub-hypothesis 1: There will be a greater decrease in the Global Deficit Scores (GDS; an overall measure of cognitive impairment) post SAET in comparison to the control condition.
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
- Single (Outcomes Assessor)
盲法说明
Participants will be randomized into either the exercise or stretching condition in a 1:1 fashion. The outcome assessors will be blinded at all times while the intervention specialist (study trainers) will unblind themselves prior to the participants first intervention appointment.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active duty, male or female, ages 18 to 55
- •History of at least one mTBI sustained more than 1 month ago
- •Service members (SMs) with ongoing symptoms
排除标准
- •SMs who sustained a TBI of any severity within 1 month of enrollment
- •History of moderate, severe, or penetrating TBI
- •Current substance use disorder
- •History of a neurological disease (e.g., multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder)
- •An acute orthopedic injury that limits the capacity to complete study procedures
结局指标
主要结局
Neurobehavioral Symptom Change
时间窗: 6 Months
Change in the Neurobehavioral Symptoms Inventory (NSI) from pre- to post-SAET. Neurobehavioral symptoms will be assessed using the Neurobehavioral Symptom Inventory (NSI) which captures multiple neurobehavioral symptoms including cognitive, somatosensory, vestibular, and affective. Furthermore, this 22 item self-report questionnaire is well validated in research studies on TBI in military populations, it has known reliability and validity, as well as guidelines for assessment of change.
次要结局
- Warfighter readiness based on Combat Fitness Test(6 Months)
- Maximal oxygen consumption(6 Months)
- Cognitive Impairment Change(6 Months)
- Change in level of occupational performance(6 months)