- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06243016
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
Status
Not yet recruiting
Conditions
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
- Name: Dominika M Pindus, Ph.D.
- Phone Number: 217-300-7317
- Email: pindus@illinois.edu
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:
- Age 60-75 years
- BMI <40 kg/m2
- Sedentary (≥ 6 h/day sitting by a survey question)
- Not exercising regularly (i.e., not exercising at least three times a week for at least 30 minutes)
- Capable of exercising vigorously based on the Physical Activity Readiness Questionnaire (PARQ+)
- Has a medical clearance for maximal exercise and HIIT from a physician
- Normotensive or participant's blood pressure is controlled
- Intelligence quotient (IQ) ≥85
- Fasting plasma glucose <126 mg/dL
- Good or corrected vision and hearing
- Right-handed
- No significant abnormalities on the ECG during the maximal exercise test
- No signs and symptoms that suggest an underlying cardiovascular disease as recorded during the maximal exercise test by a study physician.
- No indications to prematurely stop the maximal exercise test as outlined by the ACSM's Guidelines for Exercise Testing and Prescription
Exclusion Criteria:
- Physical disability or musculoskeletal disease prohibitive to vigorous exercise
- Learning disabilities
- Cognitive impairment (MoCA <26)
- Type 1 or 2 diabetes
- Neurological condition (e.g., Multiple Sclerosis, Parkinson, Dementia, Mild Cognitive Impairment)
- Color blindness
- Brain injury (e.g., traumatic brain injury, stroke, concussion)
- Migraine headaches
- Presence of other health conditions that may be exacerbated by exercise
- History of heart disease
- High cholesterol not controlled by medication
- Signs and symptoms indicative of underlying cardiovascular
- A chronic pulmonary disease
- Emphysema
- Pulmonary embolus
- Asthma
- History of renal disease
- History of seizures
- A neuropsychiatric disorder
- Osteoporosis if it interferes with an individual's ability to exercise
- Severe back problems
- Severe arthritis if it interferes with an individual's ability to exercise
- Thyroid disorder not controlled by medication
- Polyneuropathy
- Sleep disorders
- Acquired immunodeficiency syndrome (AIDS)
- Hepatitis C
- History of long Coronavirus Disease 2019 (COVID-19)
- History of cancer
- Current or past smoking <12 months
- Corticosteroid intake < 31 days before screening
- Opioids taken < 6 months from screening
- Anabolic androgens taken < 31 days before screening
- A serious illness or hospitalization in the last six months
- Currently taking medications that can affect the central nervous system (except for anxiolytics)
- 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
Keywords
Other Study ID 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
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.
Clinical Trials on Aging
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
Radboud University Medical CenterNot yet recruitingAging | Aging Well | Immuno Aging
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
San Diego State UniversityCompleted
-
Lithuanian Sports UniversityCompletedAging | Healthy AgingLithuania
-
Amazentis SAproDERM GmbHCompleted
-
University of West AtticaNot yet recruiting
-
University of Santiago de CompostelaAgencia Estatal de Investigación, SpainRecruiting
-
Beijing HospitalBGI-ShenzhenCompletedAging | Healthy Aging
Clinical Trials on High-Intensity Interval Training (HIIT) Breaks to Sitting
-
Université de SherbrookeRecruiting
-
Mayo ClinicRecruitingCardiac RehabilitationUnited States
-
Karolinska University HospitalKarolinska InstitutetUnknownDermatomyositis | PolymyositisSweden
-
Chang Gung Memorial HospitalCompletedHeart Failure | Morality | Remodeling, VentricularTaiwan
-
Brock UniversityCompletedCardiovascular Diseases | Metabolic SyndromeCanada
-
McMaster UniversityUnknown
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedKnee OsteoarthritisUnited States
-
Centre Hospitalier Universitaire VaudoisRecruitingPeripheral Arterial DiseaseSwitzerland
-
Amsterdam UMC, location VUmcRecruitingExercise | Brain Tumor, PrimaryNetherlands
-
VA Office of Research and DevelopmentAtlanta VA Medical CenterNot yet recruitingStroke | Stroke Rehabilitation | Walking, Difficulty | Lower Extremity Weakness, SpasticUnited States