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临床试验/NCT03084211
NCT03084211已完成不适用

A Randomized Controlled Trial Comparing Prescribed Light Exercise to Standard Management for Emergency Department Patients With Acute Mild Traumatic Brain Injury.

Mount Sinai Hospital, Canada2 个研究点 分布在 1 个国家目标入组 367 人开始时间: 2017年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
367
试验地点
2
主要终点
proportion of patients with PCS

研究概览

简要总结

Introduction: Current guidelines for treating patients with mild traumatic brain injury (MTBI) recommend a period of cognitive rest and gradual return to usual activities with avoidance of any activity that exacerbates symptoms. However, recent studies have reported prolonged rest beyond 48 hours might hinder MTBI recovery, and there is limited evidence to suggest following guidelines has a positive impact on prognosis. Given the paucity of effective management strategies to prevent post-concussion syndrome (PCS) and emerging evidence of the benefits of exercise in MTBI patients, there is an urgent need for more research on the effectiveness of an early exercise intervention in the acute MTBI patient population as prevention of PCS.

Research Question: Among adult (18-64 years) patients presenting to the ED with a discharge diagnosis of acute MTBI (defined by the Zurich consensus statement), does prescribing light exercise (ie: 30 min daily walking) reduce the proportion of patients with PCS at 30 days, compared to standard discharge instructions?

Methods: This will be a randomized controlled trial of adult (18-64 years) patients discharged from an academic ED diagnosed with MTBI occurring within 48 hours of the index ED visit. The intervention group will receive discharge instructions prescribing 30 minutes of light exercise (ie: walking) and the control group will be instructed to gradually return to activities. Discharge instructions will be read by the attending physician or ED nurse. Patients will be provided a printed copy of the discharge instructions. Depending on their preferences, patients will be contacted by email or by telephone to complete the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), a validated, 16 item questionnaire.

The primary outcome of this study will be the proportion of patients with PCS at 30 days, defined as an increase from baseline of ≥ 3 symptoms on the validated RPQ at 1 month. Secondary outcomes will include change in RPQ from baseline to 72 hours, 7 days, 14 days, 30 days post initial ED visit, number of missed days of school or work and repeat visits to a healthcare provider. To assess compliance with ED discharge instructions, patients will be asked to complete a daily activity journal and will be given fitness tracking devices.

详细描述

Introduction:The emergency department (ED) is the first point of health care contact for most head injured patients. The majority (estimated 85%) of patients suffering head injury will not have intra-cranial damage requiring neurosurgical consultation, but may have symptoms of mil traumatic brain injury (MTBI). Patients with MTBI may have physical, emotional, behavioral, or cognitive symptoms such as headache, sleep disturbance, disorders of balance, fatigue, irritability, memory and concentration problems, and the majority have self-limited symptoms that abate within 7 to 10 days. Although early and spontaneous resolution occurs in most patients, a small proportion of adults with MTBI will have a protracted course. It is estimated between 15-30% of patients with MTBI develop post-concussion syndrome (PCS), which is a persistence of head injury symptoms after MTBI.3 PCS usually lasts 2-4 months, and the symptoms typically peak 4-6 weeks following the injury4. However, in a smaller percentage of patients, the symptoms of PCS last for a year or longer. Approximately 20% of adults with PCS will not have returned to full-time work 1 year after the initial injury, and some are disabled permanently by PCS.

Current guidelines recommend a period of 'cognitive rest' and stepwise return to usual activities following MTBI. Cognitive rest is defined as the avoidance of mental activities that may trigger symptoms, such as watching television, using the computer, exercising, or talking on the phone. Patients following 'return to usual activity' instructions are encouraged to only resume normal activities once symptoms have resolved, and if symptoms return upon recommencement of activities, to return to rest. However, a recent systematic review of early educational interventions in the ED for MTBI concluded there are no clear and consistent interventions or standard management practices that exist for this population. Additionally, previous research evaluating a period of strict bed rest, which includes both physical and cognitive rest, has also not been shown to decrease severity or duration of MTBI symptoms. Based on the best available evidence, current guidelines for the management of MTBI suggest complete bed rest should be avoided after the first 48 hours post-injury.

Regular exercise has been shown to have positive effects on well-being, including mental health, improved self esteem, sleep and memory. Recent studies including patients with PCS have reported exercise treatment programs improved exercise tolerance and decreased symptoms, even for those patients where exercise previously exacerbated PCS symptoms. Additionally, Wise et al., randomized patients with severe TBI to either a structured exercise program for 10 weeks or usual care and found patients in the exercise group were less depressed and reported better health status compared to those not included in the exercise program.

Rationale: Given the paucity of effective management strategies that prevent PCS following MTBI and emerging evidence of the benefits of exercise in MTBI patients, there is an urgent need for more research on the effectiveness of an early exercise intervention in the acute MTBI patient population as prevention of PCS.

Research Question: Among adult (18-64 years) patients presenting to the ED with a discharge diagnosis of acute MTBI (defined by the Zurich consensus statement), does prescribing light exercise (ie: 30 min daily walking) reduce the proportion of patients with PCS at 30 days, compared to standard discharge instructions?

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • MTBI occurring within 48 hours of the index emergency department visit

排除标准

  • Acute intracranial injury identified on head CT
  • Multisystem injuries prohibiting light exercise
  • Existing medical condition that would compromise ability to participate in light exercise
  • GCS < 15 at time of ED discharge
  • Underlying neurological condition resulting in communication difficulties
  • Insurmountable language barrier
  • Inability to follow-up via telephone
  • Alcohol or drug intoxication

结局指标

主要结局

proportion of patients with PCS

时间窗: 30 days

Defined as an increase from baseline of ≥ 3 symptoms on the validated Rivermead Post-Concussion Symptoms Questionnaire

次要结局

  • Change in RPQ from baseline(72 hours, 7 days, 14 days, 30 days post initial ED visit)
  • Days of school or work missed(72 hours, 7 days, 14 days, 30 days post initial ED visit)
  • Return visits to a health care provider(72 hours, 7 days, 14 days, 30 days post initial ED visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Varner, MD

Clinician Scientist

Mount Sinai Hospital, Canada

研究点 (2)

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