AgingHIIT2SITLessNCT06243016
Breaking Sitting with High-intensity Interval Training for Brain Health
A study testing High-Intensity Interval Training (HIIT) Breaks to Sitting and Light-Intensity Interval Training (LIIT) Breaks to Sitting in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- High-Intensity Interval Training (HIIT) Breaks to Sitting and Light-Intensity Interval Training (LIIT) Breaks to Sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-75 years
- BMI <40 kg/m2
- Sedentary (≥ 6 h/day sitting by a survey question)
- 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)
- Capable of exercising vigorously based on the Physical Activity Readiness Questionnaire (PARQ+)
- Has a medical clearance for maximal exercise and HIIT from a physician
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- 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
- Concussion if more than 12 months before the study screening.
- 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
Who cannot join
- 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
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- 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 disease
- 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 if not in full remission for at least 12 months and if a participant had the history of chemotherapy
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
Dominika M Pindus, PhD, 2173007317, pindus@illinois.edu
About this study
Official title: 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?
Read the 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.
- Conditions
- Aging
- Being tested
- High-Intensity Interval Training (HIIT) Breaks to Sitting, Light-Intensity Interval Training (LIIT) Breaks to Sitting
- Keywords
- High-intensity interval training, Sitting, Executive functions, Inhibitory control, Episodic memory, Event-related potentials, Functional connectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Training (HIIT) Breaks to SittingBehavioural
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 SittingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training (HIIT) Breaks | Active comparator | Sitting interrupted every 30 min by 6-min HIIT bouts. Receives: Behavioral: High-Intensity Interval Training (HIIT) Breaks to Sitting |
| Light-Intensity Interval Training (HIIT) Breaks | Sham comparator | Sitting interrupted every 30 min by 6-min LIIT bouts. Receives: Behavioral: Light-Intensity Interval Training (LIIT) Breaks to Sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before intervention, 2 x during the intervention (50 min and 120 min into the intervention), and immediately after the intervention
Secondary outcomes (3)
Change in cognitive functions
A modified Eriksen flanker task will be used to measure inhibitory control.
Measured: 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
An antisaccade tasks will be used to measure inhibitory control. A mnemonic discrimination task will be used to measure episodic memory.
Measured: Immediately before intervention and immediately after the intervention
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.
Measured: Immediately before intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start7 May 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dominika M Pindus, Ph.D., Principal investigator, University of Illinois Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243016
- Sponsor's protocol ID
- 23938
- Other IDs
- 1R21AG080411-01A1
- Acronym
- HIIT2SITLess
- Status last verified
- Feb 2025
- First submitted
- 25 Oct 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pindus DM, Paluska S, So J, Wyczesany M, Ligeza TS, Sarol J, Kuang J, Quiroz FB, Shanmugam R, Syed T, Kos M, Khan N, Hillman C, Kramer A. Breaking prolonged sitting with high-intensity interval training to improve cognitive and brain health in middle-aged and older adults: a protocol for the pilot feasibility HIIT2SITLess trial. BMJ Open. 2025 May 7;15(5):e095415. doi: 10.1136/bmjopen-2024-095415.
PubMed 40341152
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Prolonged Sitting with High-intensity Interval Training to Improve Cognitive and Brain Health in Older Adults: a Pilot Feasibility Trial.
- ClinicalTrials.gov ID
- NCT06243016
- Acronym / sponsor ID
- HIIT2SITLess / 23938
- Conditions
- Aging
- Keywords
- High-intensity interval training, Sitting, Executive functions, Inhibitory control, Episodic memory, Event-related potentials, Functional connectivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Northeastern University, National Institute on Aging (NIA)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training (HIIT) Breaks | Active comparator | Behavioral: High-Intensity Interval Training (HIIT) Breaks to SittingSitting interrupted every 30 min by 6-min HIIT bouts. |
| Light-Intensity Interval Training (HIIT) Breaks | Sham comparator | Behavioral: Light-Intensity Interval Training (LIIT) Breaks to SittingSitting interrupted every 30 min by 6-min LIIT bouts. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 40-75 years
- BMI <40 kg/m2
- Sedentary (≥ 6 h/day sitting by a survey question)
- 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)
- Capable of exercising vigorously based on the Physical Activity Readiness Questionnaire (PARQ+)
Key exclusion criteria (36 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval Training (HIIT) Breaks to SittingHIIT 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. | Behavioural | High-Intensity Interval Training (HIIT) Breaks |
| Light-Intensity Interval Training (LIIT) Breaks to SittingLIIT 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. | Behavioural | Light-Intensity Interval Training (HIIT) Breaks |
Primary outcome
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.
3 secondary outcomes
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
Change in cognitive functions
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 40341152Pindus DM, Paluska S, So J, Wyczesany M, Ligeza TS, Sarol J, Kuang J, Quiroz FB, Shanmugam R, Syed T, Kos M, Khan N, Hillman C, Kramer A. Breaking prolonged sitting with high-intensity interval training to improve cognitive and brain health in middle-aged and older adults: a protocol for the pilot feasibility HIIT2SITLess trial. BMJ Open. 2025 May 7;15(5):e095415. doi: 10.1136/bmjopen-2024-095415.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominika M Pindus, Ph.D. principal investigator
University of Illinois Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training (HIIT) Breaks to Sitting and Light-Intensity Interval Training (LIIT) Breaks to Sitting in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominika M Pindus, Ph.D. (217-300-7317, pindus@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.