Department of Clinical Neurosciences, Division of Physical Medicine and Rehabilitation, University of Calgary, Calgary, AB, Canada.
Information Technologies, University of Calgary, Calgary, AB, Canada.
BMC Neurol. 2020 Feb 5;20(1):46. doi: 10.1186/s12883-020-1622-x.
Persistent post-concussive symptoms (PPCS) affect up to 30% of individuals following mild traumatic brain injury. PPCS frequently includes exercise intolerance. Sub-symptom threshold aerobic exercise has been proposed as a treatment option for symptom burden and exercise intolerance in this population. The primary aim of this study is to evaluate whether a progressive, sub-symptom threshold aerobic exercise program can alleviate symptom burden in adults with PPCS.
Fifty-six adults (18-65) with PPCS (>3mos-5 yrs) will be randomized into two groups: an immediate start 12-week aerobic exercise protocol (AEP) or delayed start 6-week placebo-like stretching protocol (SP), followed by AEP. Aerobic or stretching activities will be completed 5x/week for 30 mins during the intervention. Online daily activity logs will be submitted. Exercise prescriptions for the AEP will be 70-80% of heart rate at the point of symptom exacerbation achieved on a treadmill test with heart rate monitoring. Exercise prescription will be updated every 3-weeks with a repeat treadmill test. The Rivermead Post-concussion Symptom Questionnaire will be the primary outcome measure at 6 and 12-weeks of intervention. Secondary outcomes include assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including γ-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA) all measured at 6 and 12-weeks of intervention.
This trial will evaluate the use of aerobic exercise as an intervention for adults with PPCS, thus expanding our knowledge of this treatment option previously studied predominantly for adolescent sport-related concussion.
ClinicalTrials.gov - NCT03895450 (registered 2019-Feb-11).
持续性脑震荡后症状(PPCS)影响多达 30%的轻度创伤性脑损伤患者。PPCS 常伴有运动不耐受。亚症状阈有氧运动已被提议作为该人群症状负担和运动不耐受的治疗选择。本研究的主要目的是评估渐进式、亚症状阈有氧运动方案是否可以减轻 PPCS 成年人的症状负担。
56 名(18-65 岁)患有 PPCS(>3 个月至 5 年)的成年人将随机分为两组:立即开始 12 周的有氧运动方案(AEP)或延迟开始 6 周的安慰剂样伸展方案(SP),然后进行 AEP。在干预期间,每周 5 次进行 30 分钟的有氧运动或伸展活动。将在线提交每日活动日志。AEP 的运动处方将是在跑步机测试中达到症状恶化时心率的 70-80%,同时进行心率监测。每 3 周更新一次运动处方,并重复跑步机测试。Rivermead 脑震荡后症状问卷将是干预 6 周和 12 周的主要结局测量指标。次要结局包括头痛、生活质量、情绪、焦虑、疲劳、头晕、睡眠参数、白天嗜睡等特定症状的评估,以及血液生物标志物和磁共振成像和光谱数据,用于定量测量脑代谢物,包括γ-氨基丁酸(GABA)、谷胱甘肽、谷氨酸和 N-乙酰天冬氨酸(NAA),所有这些都将在干预的 6 周和 12 周进行测量。
本试验将评估有氧运动作为治疗 PPCS 成年人的干预措施,从而扩展我们对这种治疗选择的认识,这种治疗选择以前主要针对青少年运动相关脑震荡进行了研究。
ClinicalTrials.gov - NCT03895450(2019 年 2 月 11 日注册)。