NCT07727577

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Aug 2028

First Submitted

Initial submission to the registry

July 17, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

July 17, 2026

Last Update Submit

August 11, 2026

Conditions

Keywords

Cognitive FlexibilityPrefrontal Cortex ActivationAgingAcute effects of high-intensity interval exercise on cognitive flexibility and prefrontal brain activity in healthy older adults

Outcome Measures

Primary Outcomes (2)

  • 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).

  • 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.

Secondary Outcomes (2)

  • Correlation Between Cardiorespiratory Fitness (VO₂max ) and Change in Cognitive Flexibility

    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

    Baseline (Visit 1) for VO₂max; pre- and post-exercise on Visit 2 (approximately 40-45 minutes apart) for HbO/HbR

Study Arms (1)

HIIT session

EXPERIMENTAL

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.

Behavioral: High-Intensity Interval Training

Interventions

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.

HIIT session

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colby-Sawyer College

New London, New Hampshire, 03257, United States

Location

Related Publications (12)

  • 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/adbi.202400231. Epub 2024 Jul 29.

    PMID: 39074260BACKGROUND
  • 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/j.1476-5381.2012.01970.x.

    PMID: 22486393BACKGROUND
  • 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/s40798-021-00344-4.

    PMID: 34279765BACKGROUND
  • 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: 10.1177/17470218211048807. Epub 2021 Oct 11.

    PMID: 34523365BACKGROUND
  • 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/fpsyg.2020.01106. eCollection 2020.

    PMID: 32547460BACKGROUND
  • 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/jsep.31.4.505.

    PMID: 19842545BACKGROUND
  • 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/bul0000460. Epub 2025 Jan 30.

    PMID: 39883421BACKGROUND
  • 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/j.brainres.2012.02.068. Epub 2012 Mar 4.

    PMID: 22480735BACKGROUND
  • 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/fnagi.2021.615247. eCollection 2021.

    PMID: 33776741BACKGROUND
  • 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/s41598-025-91833-z.

    PMID: 40000786BACKGROUND
  • 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/fnhum.2019.00260. eCollection 2019.

    PMID: 31417381BACKGROUND
  • Cantelon JA, Giles GE. A Review of Cognitive Changes During Acute Aerobic Exercise. Front Psychol. 2021 Dec 16;12:653158. doi: 10.3389/fpsyg.2021.653158. eCollection 2021.

    PMID: 34975602BACKGROUND

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Kell Grandjean da Costa, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 27, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
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

Locations