The exercise and concussion health study (TECHS): Pilot and feasibility protocol

IF 1.5 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Emma M. Tinney , Mark C. Nwakamma , Goretti España-Irla , Madeleine Perko , Ryan Luke Sodemann , Jacqueline Caefer , Julia Manczurowsky , Charles H. Hillman , Alexandra Stillman , Timothy P. Morris
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引用次数: 0

Abstract

Mild traumatic brain injury (mTBI) is a prevalent neurological condition, affecting millions worldwide, and frequently resulting in persistent cognitive impairment that significantly impacts daily functioning. Current clinical management and recommendations lack evidence based therapeutic interventions, with treatment approaches limited to symptom monitoring and activity modification. Non-pharmaceutical interventions are needed to promote cognitive recovery and mitigate long-term consequences of mTBI. The goal of this randomized control pilot study is to evaluate the feasibility and preliminary efficacy of a symptom-guided and virtually delivered aerobic exercise intervention for improving cognitive function following mTBI. We are conducting a 12-week pilot randomized control trial of exercise to promote recovery from mTBI, which aims to recruit 24 participants who have suffered an mTBI within the last year and are between the ages of 18–55 years old. Participants are randomly assigned to one of two groups: an intervention group receiving 90 min of virtually-delivered, symptom-guided aerobic exercise weekly for 12 weeks, or a control group receiving 90 min of virtually-delivered balance exercises weekly for 12 weeks. Comprehensive assessments, including cognitive testing and multimodal neuroimaging, were conducted pre and post intervention. We implement physical activity monitoring during weeks 1, 6, and 12 using accelerometry to measure behavior changes. This study will establish the feasibility of virtual exercise delivery in mTBI populations and preliminary evidence regarding cognitive and brain health benefits of aerobic exercise in mTBI. Results will inform future large-scale trials and contribute to an accessible, evidence-based intervention for cognitive recovery after mTBI.

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运动和脑震荡健康研究(TECHS):试点和可行性方案。
轻度创伤性脑损伤(mTBI)是一种普遍的神经系统疾病,影响着全世界数百万人,并经常导致持续的认知障碍,严重影响日常功能。目前的临床管理和建议缺乏基于证据的治疗干预措施,治疗方法仅限于症状监测和活动改变。需要非药物干预来促进认知恢复和减轻mTBI的长期后果。这项随机对照先导研究的目的是评估症状引导和虚拟有氧运动干预改善mTBI后认知功能的可行性和初步疗效。我们正在进行一项为期12周的运动促进mTBI恢复的随机对照试验,旨在招募24名年龄在18-55岁之间的参与者,他们在过去一年内患有mTBI。参与者被随机分配到两组中的一组:干预组每周接受90分钟的虚拟提供的、症状指导的有氧运动,持续12周;对照组每周接受90分钟的虚拟提供的平衡运动,持续12周。综合评估,包括认知测试和多模态神经成像,在干预前后进行。我们在第1、6和12周实施身体活动监测,使用加速度计测量行为变化。本研究将确定虚拟运动交付在mTBI人群中的可行性,并初步证明有氧运动对mTBI患者的认知和大脑健康益处。结果将为未来的大规模试验提供信息,并为mTBI后认知恢复提供可获得的、基于证据的干预措施。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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