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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06243016
Other study ID # 23938
Secondary ID 1R21AG080411-01A
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 31, 2024
Est. completion date May 31, 2026

Study information

Verified date January 2024
Source University of Illinois at Urbana-Champaign
Contact Dominika M Pindus, Ph.D.
Phone 217-300-7317
Email pindus@illinois.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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?


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 54
Est. completion date May 31, 2026
Est. primary completion date May 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Illinois at Urbana-Champaign Urbana Illinois

Sponsors (3)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign National Institute on Aging (NIA), Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in task-evoked brain activity 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 Change in cognitive functions 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
Secondary Change in cognitive functions 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
Secondary Change in resting stated and task evoked brain activity 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
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