[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07727577":3,"trial-entities:NCT07727577":135,"trial-summary:NCT07727577":138},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":50,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":75,"locations":78,"central_contacts":93,"overall_officials":95,"references":96,"see_also_links":134},"NCT07727577","P20GM103506","Cardiorespiratory Fitness and Acute High-Intensity Exercise Effects on Brain and Cognitive Function in Older Adults","NOT_YET_RECRUITING","2028-08-01","2026-07","2026-07-27","2026-08-01","Colby-Sawyer College","OTHER",false,"The goal of this clinical trial is to learn whether a single session of high-intensity interval exercise (HIIT) affects cognitive performance and brain activity in older adults, and whether cardiorespiratory fitness influences these effects. The main questions it aims to answer are:\n\n* Does a single HIIT session change performance on a task-switching test of cognitive flexibility?\n* Does a single HIIT session change prefrontal brain activity during cognitive testing, as measured by functional near-infrared spectroscopy (fNIRS)?\n* Do older adults with higher cardiorespiratory fitness show greater cognitive and brain changes in response to HIIT than those with lower fitness?\n\nParticipants will:\n\n* Visit the laboratory on two separate days\n* Complete a sub-maximal graded exercise test during the first visit to measure cardiorespiratory fitness\n* Complete a single \\~30-minute HIIT cycling session during the second visit\n* Complete a task-switching cognitive test before and after the HIIT session\n* Have their brain activity monitored with fNIRS while completing the cognitive tests","Cognitive decline is one of the most consequential changes associated with aging, and executive functions-the set of higher-order cognitive processes that allow people to plan, adapt, and control their behavior-are especially susceptible to age-related change because they depend heavily on the prefrontal cortex, a brain region that shows some of the earliest and most pronounced structural and functional changes with age. Cognitive flexibility, the ability to shift rapidly between competing task rules or mental sets, is one specific executive function that supports many everyday activities, including driving, multitasking, and decision-making, and it can be measured experimentally using a task-switching paradigm that compares performance on trials requiring a rule switch to trials that repeat the same rule.\n\nPhysical exercise is increasingly recognized as a non-pharmacological approach that may help preserve cognitive and brain health in older adults, but the evidence on the acute (single-session) effects of exercise on cognition is inconsistent. Outcomes appear to depend on exercise intensity, duration, the timing of cognitive testing relative to exercise, the population studied, and the specific cognitive domain assessed. High-intensity interval training (HIIT)-brief, repeated bouts of vigorous exercise separated by recovery periods-produces strong cardiovascular, metabolic, and neuroendocrine responses in a short amount of time and has been associated with greater gains in cardiorespiratory fitness and cognition than continuous moderate-intensity exercise in some populations. However, one influential framework, the reticular-activating hypofrontality (RAH) model, proposes that intense physical exertion can temporarily divert neural resources away from the prefrontal cortex toward brain regions controlling movement and basic physiological regulation, which could transiently impair executive function immediately after high-intensity exercise. This model has rarely been tested directly in older adults using simultaneous brain imaging and cognitive testing, and it is not yet known whether an individual's cardiorespiratory fitness level protects against this kind of transient impairment.\n\nThis study is designed to address that gap by examining, within the same older adults, how a single bout of HIIT affects both performance on a task-switching test of cognitive flexibility and underlying prefrontal brain activity, and by testing whether cardiorespiratory fitness-measured on a continuous scale rather than as a simple high\u002Flow grouping-moderates these acute responses. Brain activity will be assessed using functional near-infrared spectroscopy (fNIRS), a non-invasive optical imaging method in which a sensor cap placed on the participant's forehead emits and detects near-infrared light to track relative changes in oxygenated and deoxygenated hemoglobin concentrations in the prefrontal cortex; increases in oxygenated hemoglobin coupled with decreases in deoxygenated hemoglobin are interpreted as increased regional brain activation. Compared with functional MRI, fNIRS is more portable, less expensive, and more tolerant of movement, while offering better spatial resolution than EEG, making it well suited for studying exercise-related brain responses in older adults.\n\nParticipants will attend two laboratory visits on separate days at the Exercise and Cognition Lab. The first visit establishes each participant's cardiorespiratory fitness and familiarizes them with study procedures: after health screening and baseline physical measures, participants will practice the task-switching paradigm on a laptop using PsychoPy® stimulus presentation software until their performance stabilizes, in order to minimize learning effects during the later experimental session. They will then complete a submaximal graded exercise test on a cycle ergometer, following a validated multistage protocol (American College of Sports Medicine submaximal cycle ergometer protocol) consisting of four consecutive 3-minute stages of progressively increasing workload. Heart rate and workload recorded during each stage are used to extrapolate, via the established linear relationship between heart rate and oxygen consumption, an estimate of maximal oxygen uptake (VO₂max) at the participant's age-predicted maximal heart rate, providing a safe and time-efficient index of cardiorespiratory fitness without requiring participants to exercise to true maximal exertion.\n\nThe second visit constitutes the experimental exercise session. After a health status check, participants will be fitted with the fNIRS sensor cap, positioned over prefrontal regions according to the standard EEG 10-20 placement system, and will complete the task-switching cognitive assessment while brain activity is recorded (pre-exercise timepoint). The fNIRS cap will then be removed and participants will complete the HIIT protocol on a cycle ergometer: four 4-minute bouts of high-intensity cycling, controlled to approximately 85-90% of individually determined maximal power output and heart rate, separated by 3-minute periods of passive or light active recovery. Heart rate, rating of perceived exertion, and pedaling cadence are monitored and recorded each minute throughout the exercise bout, and workload is adjusted as needed to keep participants within the prescribed intensity range; exercise may be modified or stopped at the study team's discretion based on participant signs or symptoms. Heart rate throughout both visits is tracked continuously using a wearable optical heart rate sensor worn on the upper arm or forearm. Immediately after the exercise bout, participants are refitted with the fNIRS cap and repeat the task-switching assessment while brain activity is again recorded (post-exercise timepoint), allowing within-participant comparison of cognitive and prefrontal neural responses before versus immediately after a single session of high-intensity exercise.\n\nCardiorespiratory fitness values derived from the submaximal test will be examined as a continuous moderating variable in statistical models of the pre-to-post exercise changes in cognitive and brain outcomes, alongside relevant covariates such as age, sex, grip strength, and lean body mass, using repeated-measures and mixed-effects statistical approaches. This design allows the study to test not only whether HIIT produces measurable shifts in executive function and prefrontal activation immediately afterward, but also whether individual differences in fitness help explain who is more or less susceptible to such shifts.\n\nThis project builds on preliminary pilot work conducted by the same research team using a related experimental design, which demonstrated that the task-switching paradigm behaves as expected (slower responses on switch versus repeat trials) and that reliable, good-quality fNIRS signal can be obtained from older adult participants using this cap montage and analysis pipeline. Findings from this study are intended to clarify the neurocognitive mechanisms underlying acute responses to high-intensity exercise in older adults and to inform more precise, individualized guidance on how and when high-intensity exercise might be safely incorporated into the daily routines of older adults, including consideration of timing relative to cognitively demanding activities.",[18,19,20,21],"Healthy Aging","Cognitive Benefits","Cardio Respiratory Fitness","Brain Activity",[23,24,25,26],"Cognitive Flexibility","Prefrontal Cortex Activation","Aging","Acute effects of high-intensity interval exercise on cognitive flexibility and prefrontal brain activity in healthy older adults","INTERVENTIONAL","BASIC_SCIENCE",[30],"NA",{"count":32,"type":33},50,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","High-Intensity Interval Training","A single session of high-intensity interval training (HIIT) performed on a cycle ergometer, consisting of 4 bouts of 4 minutes of high-intensity cycling separated by 3 minutes of passive or light active recovery (total exercise session approximately 30 minutes, excluding warm-up and cool-down). High exercise intensity is individually prescribed and controlled at approximately 85-90% of each participant's maximal power output and maximal heart rate, both estimated from a submaximal graded exercise test (American College of Sports Medicine submaximal cycle ergometer protocol) completed during a prior laboratory visit. During the recovery intervals, participants cycle at a light workload (30-50% of maximum power output). Participants are asked to maintain a cadence of approximately 50-60 revolutions per minute throughout. Heart rate, rating of perceived exertion (RPE), and cadence are monitored and recorded every minute during the session by a trained study team member.",[40],"HIIT session",[42,46],{"measure":43,"description":44,"timeFrame":45},"Change in Cognitive Flexibility (Task-Switching Performance)","Changes in reaction time (milliseconds) switch cost, calculated as the difference in mean reaction time between switch trials and repeat trials, on a computerized numerical classification task-switching paradigm. Larger switch costs indicate poorer cognitive flexibility.","Immediately before (pre-exercise) and immediately after (post-exercise) a single HIIT session (approximately 40-45 minutes apart).",{"measure":47,"description":48,"timeFrame":49},"Change in Prefrontal Cortex Activation (fNIRS)","Relative changes (ΔμM) in oxygenated hemoglobin (HbO) and deoxyhemoglobin (HbR) concentrations in prefrontal cortex regions, measured via functional near-infrared spectroscopy (fNIRS) during task-switching performance. Increased HbO and decreased HbR reflects increased regional brain activation.","Immediately before (pre-exercise) and immediately after (post-exercise) a single HIIT session.",[51,55],{"measure":52,"description":53,"timeFrame":54},"Correlation Between Cardiorespiratory Fitness (VO₂max ) and Change in Cognitive Flexibility","Correlation between estimated VO₂max (mL\u002Fkg\u002Fmin), derived from the ACSM submaximal cycle ergometer test protocol, and the change in reaction time switch cost (milliseconds) on the computerized task-switching paradigm from pre- to post-exercise.","Baseline (Visit 1) for VO₂max; pre- and post-exercise on Visit 2 (approximately 40-45 minutes apart) for switch cos",{"measure":56,"description":57,"timeFrame":58},"Correlation Between Cardiorespiratory Fitness and Change in Prefrontal Cortex Activation","Correlation between estimated VO₂max (mL\u002Fkg\u002Fmin), derived from the ACSM submaximal cycle ergometer test protocol, and the change in oxygenated hemoglobin (HbO) and deoxyhemoglobin (HbR) concentrations (ΔμM) in the prefrontal cortex, measured via fNIRS, from pre- to post-exercise.","Baseline (Visit 1) for VO₂max; pre- and post-exercise on Visit 2 (approximately 40-45 minutes apart) for HbO\u002FHbR","ALL","55 Years","79 Years",true,{"inclusion":64,"exclusion":68,"raw_text":74},[65,66,67],"Physical active in the last three months (\\>3x\u002Fweek of 30 minutes of moderate exercise)","To participate in the study, participants must answer \"no\" to all the Physical Activity Readiness questionnaire (PAR-Q) questions and have no signs and symptoms of cardiovascular, metabolic, and kidney diseases following the decision tree of the American College of Sports Medicine screening procedure.","Agree to have their data stored in a human performance database for future use. Agree to have their data stored in a repository per the requirement of peer-reviewed scientific journals, which may require data to be stored in a repository as a condition for publication. Such repositories are online databases, in which coded data is linked (no link to participants personally) to the journal article citation. Must read, understand, and sign the informed consent form.",[69,70,71,72,73],"Use of illicit drugs, excessive alcohol, and\u002For performance-enhancing drugs.","Have any current orthopedic injury.","Have implanted medical devices.","Serious medical conditions limiting the ability to safety participate in either the PA interventions; these include dementia, symptomatic heart or vascular disease, severe hypertension, recent myocardial infarction, stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease or active cancer","Mini-mental examination score \\\u003C 23","Inclusion Criteria:\n\n* Physical active in the last three months (\\>3x\u002Fweek of 30 minutes of moderate exercise)\n* To participate in the study, participants must answer \"no\" to all the Physical Activity Readiness questionnaire (PAR-Q) questions and have no signs and symptoms of cardiovascular, metabolic, and kidney diseases following the decision tree of the American College of Sports Medicine screening procedure.\n* Agree to have their data stored in a human performance database for future use. Agree to have their data stored in a repository per the requirement of peer-reviewed scientific journals, which may require data to be stored in a repository as a condition for publication. Such repositories are online databases, in which coded data is linked (no link to participants personally) to the journal article citation. Must read, understand, and sign the informed consent form.\n\nExclusion Criteria:\n\n* Use of illicit drugs, excessive alcohol, and\u002For performance-enhancing drugs.\n* Have any current orthopedic injury.\n* Have implanted medical devices.\n* Serious medical conditions limiting the ability to safety participate in either the PA interventions; these include dementia, symptomatic heart or vascular disease, severe hypertension, recent myocardial infarction, stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease or active cancer\n* Mini-mental examination score \\\u003C 23",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":12,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":90},"New London","New Hampshire","03257","United States",[85],{"name":86,"role":87,"phone":88,"email":89},"Kell Grandjean da Costa, PhD","CONTACT","603-526-3799","kell.dacosta@colby-sawyer.edu",{"lat":91,"lon":92},43.41396,-71.98508,[94],{"name":86,"role":87,"phone":88,"email":89},[],[97,101,104,107,110,113,116,119,122,125,128,131],{"pmid":98,"type":99,"citation":100},"39074260","BACKGROUND","da Costa KG, Fontes EB, Menta A, Kramer AF, Fielding RA, Verghese J, Kowaleski C, Ward N, Reid KF. Prefrontal Cortex Oxygenation During Exercise in Older Adults with Motoric Cognitive Risk Syndrome. Adv Biol (Weinh). 2025 Jun;9(6):e2400231. doi: 10.1002\u002Fadbi.202400231. Epub 2024 Jul 29.",{"pmid":102,"type":99,"citation":103},"22486393","Vina J, Sanchis-Gomar F, Martinez-Bello V, Gomez-Cabrera MC. Exercise acts as a drug; the pharmacological benefits of exercise. Br J Pharmacol. 2012 Sep;167(1):1-12. doi: 10.1111\u002Fj.1476-5381.2012.01970.x.",{"pmid":105,"type":99,"citation":106},"34279765","Marriott CFS, Petrella AFM, Marriott ECS, Boa Sorte Silva NC, Petrella RJ. High-Intensity Interval Training in Older Adults: a Scoping Review. Sports Med Open. 2021 Jul 19;7(1):49. doi: 10.1186\u002Fs40798-021-00344-4.",{"pmid":108,"type":99,"citation":109},"34523365","Jung M, Ryu S, Kang M, Javadi AH, Loprinzi PD. Evaluation of the transient hypofrontality theory in the context of exercise: A systematic review with meta-analysis. Q J Exp Psychol (Hove). 2022 Jul;75(7):1193-1214. doi: 10.1177\u002F17470218211048807. Epub 2021 Oct 11.",{"pmid":111,"type":99,"citation":112},"32547460","Heath M, Shukla D. A Single Bout of Aerobic Exercise Provides an Immediate \"Boost\" to Cognitive Flexibility. Front Psychol. 2020 May 29;11:1106. doi: 10.3389\u002Ffpsyg.2020.01106. eCollection 2020.",{"pmid":114,"type":99,"citation":115},"19842545","Ekkekakis P. Illuminating the black box: investigating prefrontal cortical hemodynamics during exercise with near-infrared spectroscopy. J Sport Exerc Psychol. 2009 Aug;31(4):505-53. doi: 10.1123\u002Fjsep.31.4.505.",{"pmid":117,"type":99,"citation":118},"39883421","Chang YK, Ren FF, Li RH, Ai JY, Kao SC, Etnier JL. Effects of acute exercise on cognitive function: A meta-review of 30 systematic reviews with meta-analyses. Psychol Bull. 2025 Feb;151(2):240-259. doi: 10.1037\u002Fbul0000460. Epub 2025 Jan 30.",{"pmid":120,"type":99,"citation":121},"22480735","Chang YK, Labban JD, Gapin JI, Etnier JL. The effects of acute exercise on cognitive performance: a meta-analysis. Brain Res. 2012 May 9;1453:87-101. doi: 10.1016\u002Fj.brainres.2012.02.068. Epub 2012 Mar 4.",{"pmid":123,"type":99,"citation":124},"33776741","Castells-Sanchez A, Roig-Coll F, Dacosta-Aguayo R, Lamonja-Vicente N, Sawicka AK, Toran-Monserrat P, Pera G, Montero-Alia P, Heras-Tebar A, Domenech S, Via M, Erickson KI, Mataro M. Exercise and Fitness Neuroprotective Effects: Molecular, Brain Volume and Psychological Correlates and Their Mediating Role in Healthy Late-Middle-Aged Women and Men. Front Aging Neurosci. 2021 Mar 8;13:615247. doi: 10.3389\u002Ffnagi.2021.615247. eCollection 2021.",{"pmid":126,"type":99,"citation":127},"40000786","Ahmadi S, Belanger M, O'Brien MW, Registe PPW, Dupuy O, Mekari S. Acute effects of high-intensity interval training and moderate-intensity continuous training on executive functions in healthy older adults. Sci Rep. 2025 Feb 25;15(1):6749. doi: 10.1038\u002Fs41598-025-91833-z.",{"pmid":129,"type":99,"citation":130},"31417381","Bae S, Masaki H. Effects of Acute Aerobic Exercise on Cognitive Flexibility Required During Task-Switching Paradigm. Front Hum Neurosci. 2019 Jul 31;13:260. doi: 10.3389\u002Ffnhum.2019.00260. eCollection 2019.",{"pmid":132,"type":99,"citation":133},"34975602","Cantelon JA, Giles GE. A Review of Cognitive Changes During Acute Aerobic Exercise. Front Psychol. 2021 Dec 16;12:653158. doi: 10.3389\u002Ffpsyg.2021.653158. eCollection 2021.",[],{"nct_id":4,"conditions":136,"biomarkers":137},[25],[],{"nct_id":4,"found":62,"summary":139,"prompt_version":149},{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This interventional study plans to enroll 50 participants. It is not specified if it is randomized or blinded.","completed","Cardiorespiratory Fitness and High-Intensity Exercise for Brain and Cognitive Function in Older Adults","This study is looking at how a single session of high-intensity interval training (HIIT) affects thinking skills and brain activity in older adults. Researchers want to see if HIIT, which involves short bursts of intense exercise on a bike, can improve your ability to switch between tasks (cognitive flexibility) and change activity in the front part of your brain (prefrontal cortex). They are also interested in whether your current fitness level plays a role in these effects. The study aims to enroll 50 healthy adults between 55 and 79 years old who are physically active and meet certain health criteria. The main goal is to understand if HIIT can offer cognitive benefits for older adults.","Cognitive and brain activity changes are measured immediately before and after a single HIIT session, approximately 40-45 minutes apart.",115,"You would participate in a single session of high-intensity interval training (HIIT) on a cycle ergometer, lasting about 30 minutes. Cognitive and brain activity tests will be done immediately before and after this exercise session.","Not stated in the trial record.",[37],"v2"]