NCT06243016

Brief 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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 7, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

October 25, 2023

Last Update Submit

February 4, 2025

Conditions

Keywords

High-intensity interval trainingSittingExecutive functionsInhibitory controlEpisodic memoryEvent-related potentialsFunctional connectivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in cognitive functions

    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

    Immediately before intervention and immediately after the intervention

  • Change in resting stated and task evoked brain activity

    Immediately before intervention and immediately after the intervention

Study Arms (2)

High-Intensity Interval Training (HIIT) Breaks

ACTIVE COMPARATOR

Sitting interrupted every 30 min by 6-min HIIT bouts.

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.

Behavioral: Light-Intensity Interval Training (LIIT) Breaks to Sitting

Interventions

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.

High-Intensity Interval Training (HIIT) Breaks

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.

Light-Intensity Interval Training (HIIT) Breaks

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.
  • +1 more criteria

You may not qualify if:

  • 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 disease
  • A chronic pulmonary disease
  • Emphysema
  • Pulmonary embolus
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dominika M Pindus, Ph.D.

    University of Illinois Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominika M Pindus, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

February 5, 2024

Study Start

May 7, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

February 7, 2025

Record last verified: 2025-02

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