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

January 29, 2024 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

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 (60-75 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

Interventional

Enrollment (Estimated)

54

Phase

  • 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 Locations

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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 60-75 years
  2. BMI <40 kg/m2
  3. Sedentary (≥ 6 h/day sitting by a survey question)
  4. Not exercising regularly (i.e., not exercising at least three times a week for at least 30 minutes)
  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

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
  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
  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
Intervention / Treatment
Active Comparator: High-Intensity Interval Training (HIIT) Breaks
Sitting interrupted every 30 min by 6-min HIIT bouts.
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.
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

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

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.

Investigators

  • 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 (Estimated)

January 31, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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