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
{"title":"The exercise and concussion health study (TECHS): Pilot and feasibility protocol","authors":"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","doi":"10.1016/j.conctc.2026.101608","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101608"},"PeriodicalIF":1.5000,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865426000153","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/1/29 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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.
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.