Breaking Sitting with High-intensity Interval Training for Brain Health (HIIT2SITLess)

February 4, 2025 updated by: University of Illinois at Urbana-Champaign

Breaking Prolonged Sitting with High-intensity Interval Training to Improve Cognitive and Brain Health in Older Adults: a Pilot Feasibility Trial.

This trial will examine whether interrupting 3.5 hours of sitting every 30 min with 6 min high intensity interval training (HIIT) breaks compared to light intensity interval training (LIIT) will improve brain health in cognitively normal older adults. This trial will test the feasibility of HIIT breaks to sitting. It will also address several important but unanswered questions: (1) Does interrupting sitting with short HIIT breaks improve frontoparietal function? (2) Can interrupting sitting with HIIT breaks improve cognitive functions?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators are conducting an acute, single site randomized crossover trial testing two conditions lasting 3.5 hours each with a one to four-weeks washout period: (1) Interrupting sitting with 6 min of high-intensity interval training (HIIT) every 30 min, and (2) interrupting sitting with 6-min light-intensity interval training (LIIT) every 30 min. Investigators will administer the conditions in a counterbalanced order to 54 older adults (40-75 years). Brain function will be assessed using event-related brain potentials and measures of functional connectivity derived from electroencephalography. Cognitive functions will be assessed using a modified Eriksen flanker task and an antisaccade task. Investigators will measure episodic memory using a mnemonic discrimination task.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • University of Illinois at Urbana-Champaign
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 40-75 years
  2. BMI <40 kg/m2
  3. Sedentary (≥ 6 h/day sitting by a survey question)
  4. Physically inactive adults based on the CSEP-PATH: Physical Activity and Sedentayr Behaviour Questionnaire (PASB-Q) Adult (low or medium physical activity range equivalent to less than 300 min of moderate intensity physical activity per week)
  5. Capable of exercising vigorously based on the Physical Activity Readiness Questionnaire (PARQ+)
  6. Has a medical clearance for maximal exercise and HIIT from a physician
  7. Normotensive or participant's blood pressure is controlled
  8. Intelligence quotient (IQ) ≥85
  9. Fasting plasma glucose <126 mg/dL
  10. Good or corrected vision and hearing
  11. Right-handed
  12. No significant abnormalities on the ECG during the maximal exercise test
  13. No signs and symptoms that suggest an underlying cardiovascular disease as recorded during the maximal exercise test by a study physician.
  14. No indications to prematurely stop the maximal exercise test as outlined by the ACSM's Guidelines for Exercise Testing and Prescription
  15. Concussion if more than 12 months before the study screening.
  16. History of cancer but in full remission for at least 12 months and no history of chemotherapy, signed off by the physician or an oncologist

Exclusion Criteria:

  1. Physical disability or musculoskeletal disease prohibitive to vigorous exercise
  2. Learning disabilities
  3. Cognitive impairment (MoCA <26)
  4. Type 1 or 2 diabetes
  5. Neurological condition (e.g., Multiple Sclerosis, Parkinson, Dementia, Mild Cognitive Impairment)
  6. Color blindness
  7. Brain injury (e.g., traumatic brain injury, stroke, concussion)
  8. Migraine headaches
  9. Presence of other health conditions that may be exacerbated by exercise
  10. History of heart disease
  11. High cholesterol not controlled by medication
  12. Signs and symptoms indicative of underlying cardiovascular disease
  13. A chronic pulmonary disease
  14. Emphysema
  15. Pulmonary embolus
  16. Asthma
  17. History of renal disease
  18. History of seizures
  19. A neuropsychiatric disorder
  20. Osteoporosis if it interferes with an individual's ability to exercise
  21. Severe back problems
  22. Severe arthritis if it interferes with an individual's ability to exercise
  23. Thyroid disorder not controlled by medication
  24. Polyneuropathy
  25. Sleep disorders
  26. Acquired immunodeficiency syndrome (AIDS)
  27. Hepatitis C
  28. History of long Coronavirus Disease 2019 (COVID-19)
  29. History of cancer if not in full remission for at least 12 months and if a participant had the history of chemotherapy
  30. Current or past smoking <12 months
  31. Corticosteroid intake < 31 days before screening
  32. Opioids taken < 6 months from screening
  33. Anabolic androgens taken < 31 days before screening
  34. A serious illness or hospitalization in the last six months
  35. Currently taking medications that can affect the central nervous system (except for anxiolytics)
  36. Current participation in an ongoing trial likely to influence exercise ability or cognitive function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High-Intensity Interval Training (HIIT) Breaks
Sitting interrupted every 30 min by 6-min HIIT bouts.
Behavioral: High-Intensity Interval Training (HIIT) Breaks to Sitting
HIIT Breaks: a 3.5-hour sitting will be interrupted every 30 min with 6-min HIIT Breaks. During sitting participants will engage in standardized sedentary activities. Each 6-min HIIT break comprises a one-minute warm-up, followed by a 2-minute high-intensity interval, one minute rest (sitting on a cycle ergometer) followed by another 2 minutes at high intensity.
Sham Comparator: Light-Intensity Interval Training (HIIT) Breaks
Sitting interrupted every 30 min by 6-min LIIT bouts.
Behavioral: Light-Intensity Interval Training (LIIT) Breaks to Sitting
LIIT Breaks: a 3.5-hour sitting will be interrupted every 30 min with 6-min LIIT Breaks. Each 6-min LIIT break comprises a one-minute warm-up, followed by a 2-minute light-intensity interval, one minute rest (sitting on a cycle ergometer) followed by another 2-minute light-intensity interval.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in task-evoked brain activity
Time Frame: Immediately before intervention, 2 x during the intervention (50 min and 120 min into the intervention), and immediately after the intervention
EEG will be used to measure event-related brain potentials including the P3b-component during an inhibitory control task.
Immediately before intervention, 2 x during the intervention (50 min and 120 min into the intervention), and immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in cognitive functions
Time Frame: Immediately before intervention, 2 x during the intervention (50 min and 120 min into the intervention), and immediately after the intervention
A modified Eriksen flanker task will be used to measure inhibitory control.
Immediately before intervention, 2 x during the intervention (50 min and 120 min into the intervention), and immediately after the intervention
Change in cognitive functions
Time Frame: Immediately before intervention and immediately after the intervention
An antisaccade tasks will be used to measure inhibitory control. A mnemonic discrimination task will be used to measure episodic memory.
Immediately before intervention and immediately after the intervention
Change in resting stated and task evoked brain activity
Time Frame: Immediately before intervention and immediately after the intervention
EEG will be used to measure functional connectivity at rest and during engagement in inhibitory control and episodic memory tasks.
Immediately before intervention and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)
Northeastern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dominika M Pindus, Ph.D., University of Illinois Urbana-Champaign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23938
  • 1R21AG080411-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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