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Cardiorespiratory Fitness and Acute High-Intensity Exercise Effects on Brain and Cognitive Function in Older Adults (ExBrain)

11 sierpnia 2026 zaktualizowane przez: Colby-Sawyer College

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:

  • Does a single HIIT session change performance on a task-switching test of cognitive flexibility?
  • Does a single HIIT session change prefrontal brain activity during cognitive testing, as measured by functional near-infrared spectroscopy (fNIRS)?
  • Do older adults with higher cardiorespiratory fitness show greater cognitive and brain changes in response to HIIT than those with lower fitness?

Participants will:

  • Visit the laboratory on two separate days
  • Complete a sub-maximal graded exercise test during the first visit to measure cardiorespiratory fitness
  • Complete a single ~30-minute HIIT cycling session during the second visit
  • Complete a task-switching cognitive test before and after the HIIT session
  • Have their brain activity monitored with fNIRS while completing the cognitive tests

Przegląd badań

Szczegółowy opis

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.

Physical 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.

This 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/low 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.

Participants 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.

The 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.

Cardiorespiratory 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.

This 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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  • Physical active in the last three months (>3x/week 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.

Exclusion Criteria:

  • Use of illicit drugs, excessive alcohol, and/or 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 < 23

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: HIIT session
All enrolled participants complete two laboratory visits. The first visit establishes cardiorespiratory fitness via a submaximal graded exercise test and familiarizes participants with the task-switching cognitive paradigm. The second visit is the experimental session: participants complete the task-switching assessment with concurrent fNIRS brain imaging immediately before and immediately after a single bout of high-intensity interval training (HIIT). Cardiorespiratory fitness is examined as a continuous moderator of pre- to post-exercise changes in cognitive and brain outcomes.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Cognitive Flexibility (Task-Switching Performance)
Ramy czasowe: Immediately before (pre-exercise) and immediately after (post-exercise) a single HIIT session (approximately 40-45 minutes apart).
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).
Change in Prefrontal Cortex Activation (fNIRS)
Ramy czasowe: Immediately before (pre-exercise) and immediately after (post-exercise) a single HIIT session.
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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Correlation Between Cardiorespiratory Fitness (VO₂max ) and Change in Cognitive Flexibility
Ramy czasowe: Baseline (Visit 1) for VO₂max; pre- and post-exercise on Visit 2 (approximately 40-45 minutes apart) for switch cos
Correlation between estimated VO₂max (mL/kg/min), 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
Correlation Between Cardiorespiratory Fitness and Change in Prefrontal Cortex Activation
Ramy czasowe: Baseline (Visit 1) for VO₂max; pre- and post-exercise on Visit 2 (approximately 40-45 minutes apart) for HbO/HbR
Correlation between estimated VO₂max (mL/kg/min), 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/HbR

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2027

Ukończenie studiów (Szacowany)

1 sierpnia 2028

Daty rejestracji na studia

Pierwszy przesłany

17 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 lipca 2026

Pierwszy wysłany (Rzeczywisty)

27 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

De-identified (coded) individual participant data will be deposited in a repository as required for publication in peer-reviewed journals. Data will be available to researchers upon reasonable request, consistent with participant consent for use in a human performance database for future research use.

Ramy czasowe udostępniania IPD

De-identified individual participant data, along with the study protocol, SAP, and analytic code, will be made available beginning at the time of associated publication, with no planned end date for availability

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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