- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06700187
Frequency of Interrupting Sitting and Cognitive Function (FISCF)
Effects of Sitting Interruption Frequency on Cognitive Function and Glucose Metabolism: A Randomized, Controlled Cross-over Study Involving Young Sedentary Adults
Rationale: Sedentary behavior (SB) has been associated with impaired cognitive function in elderly, and negatively impacts glucose metabolism. Interrupting sitting with physical activity (PA) bouts may exert beneficial effects on cognitive function via an improved glucose metabolism. Nevertheless, the impact of breaking up prolonged sitting with various frequencies of PA bouts remains unexplored in young sedentary adults. Moreover, we hypothesize that the pattern of the breaks modifies the effects. Thus, randomized controlled trials (RCTs) are highly needed to investigate the effects of interrupting sitting with different frequencies of PA on cognitive function and glucose metabolism. We now hypothesize that interrupting sitting with different frequencies of walking breaks differentially affects cognitive function and glucose metabolism.
Objective: The aim is to investigate the effects of breaking up sitting with different frequencies of PA bouts on cognitive function and glucose metabolism in young sedentary adults.
Study design: A randomised, controlled cross-over study will be performed, consisting of four interventions in a counterbalanced order: uninterrupted prolonged sitting, short breaks, moderate breaks, and long breaks.
Intervention: Participants will complete four conditions in a randomized, counterbalanced order: sitting (uninterrupted prolonged sitting without any interruptions), short breaks (walk 1 minute every 10 minutes), moderate breaks (walk 3 minutes every 30 minutes), and long breaks (walk 27 minutes during the intervention). Each condition lasts 4.5 hours.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Renyan Ma
- Phone Number: +31 883887804
- Email: renyan.ma@maastrichtuniversity.nl
Study Contact Backup
- Name: Hans Savelberg, Phd
- Phone Number: +31 433881392
- Email: hans.savelberg@maastrichtuniversity.nl
Study Locations
-
-
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Maastricht, Netherlands
- Recruiting
- Nutrition and movement science
-
Contact:
- Phone Number: +31 (0)883887804
- Email: renyan.ma@maastrichtuniversity.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men and women aged 18-35 years;
- BMI between 18.5-24.9 kg/m2;
- SB, i.e. sitting for an average of at least 9 hours per day;
- Physically inactive, i.e. engaging in exercise for less than 2 to 3 times per week;
- Stable body weight (weight gain or loss < 3 kg in the past three months);
- Willingness to engage in four 6-hour laboratory visits;
- No difficult cannulation.
Exclusion Criteria:
- Not sedentary, i.e. sitting for less than an average of 9 hours per day;
- Physically active, i.e. engaging in exercise for more than 3 times a week;
- Abuse of drugs;
- Use medication to treat BP, lipid, or glucose metabolism;
- Pregnant females.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interrupting sitting
Participants will engage in low-intensity walking breaks in different frequencies for 4.5 hours
|
Participants will engage in 27 minutes walking in different frequencies, including short breaks (walk 1 minute every 10 minutes), moderate breaks (walk 3 minutes every 30 minutes), and long breaks (walk 27 minutes in one time during the intervention).
|
|
No Intervention: Control
Paticipants will remain seated for 4.5 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental flexibility
Time Frame: baseline and 5 hours post baseline
|
It will be assessed using the computer-based Trial Making Test
|
baseline and 5 hours post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interference
Time Frame: baseline and 5 hours post baseline
|
Interference is assessed by the computer-based Stroop task
|
baseline and 5 hours post baseline
|
|
Memory
Time Frame: baseline and 5 hours post baseline
|
Memory is assessed by the computer-based n-Back Test
|
baseline and 5 hours post baseline
|
|
Attention
Time Frame: baseline and 5 hours post baseline
|
Attention is assessed by the paper-based d2 attention Test
|
baseline and 5 hours post baseline
|
|
Glucose metabolism
Time Frame: baseline, 30 minutes, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, and 5 hour post baseline
|
Concentration of plasma glucose will be tested.
|
baseline, 30 minutes, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, and 5 hour post baseline
|
|
Glucose metabolism
Time Frame: baseline, 30 minutes, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, and 5 hour post baseline
|
Concentration of serum insulin will be tested.
|
baseline, 30 minutes, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, and 5 hour post baseline
|
|
Serum brain-derived neurotrophic factor (BDNF)
Time Frame: baseline, 2 hour, 3 hour, and 5 hour post baseline
|
Concentration of serum BDNF, as one of the exploratory outcomes will be tested.
|
baseline, 2 hour, 3 hour, and 5 hour post baseline
|
|
Blood lipids
Time Frame: baseline, and 5 hours post baseline
|
As exploratory outcomes, concentration of serum total cholesterol (TC), and high-density lipoprotein cholesterol (HDL-C) will be tested.
|
baseline, and 5 hours post baseline
|
|
Serum triacylglycerol (TAG)
Time Frame: baseline, 30 minutes, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, and 5 hour post baseline
|
As another exploratory outcome, concentration of serum TAG will be tested.
|
baseline, 30 minutes, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, and 5 hour post baseline
|
|
Mood
Time Frame: baseline and 5 hours post baseline
|
Short version of Profile of Mood States (POMS) questionnaire will be used to test mood.
|
baseline and 5 hours post baseline
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Wheeler MJ, Green DJ, Ellis KA, Cerin E, Heinonen I, Naylor LH, Larsen R, Wennberg P, Boraxbekk CJ, Lewis J, Eikelis N, Lautenschlager NT, Kingwell BA, Lambert G, Owen N, Dunstan DW. Distinct effects of acute exercise and breaks in sitting on working memory and executive function in older adults: a three-arm, randomised cross-over trial to evaluate the effects of exercise with and without breaks in sitting on cognition. Br J Sports Med. 2020 Jul;54(13):776-781. doi: 10.1136/bjsports-2018-100168. Epub 2019 Apr 29.
- Wheeler MJ, Green DJ, Cerin E, Ellis KA, Heinonen I, Lewis J, Naylor LH, Cohen N, Larsen R, Dempsey PC, Kingwell BA, Owen N, Dunstan DW. Combined effects of continuous exercise and intermittent active interruptions to prolonged sitting on postprandial glucose, insulin, and triglycerides in adults with obesity: a randomized crossover trial. Int J Behav Nutr Phys Act. 2020 Dec 14;17(1):152. doi: 10.1186/s12966-020-01057-9.
- Homer AR, Taylor FC, Dempsey PC, Wheeler MJ, Sethi P, Townsend MK, Grace MS, Green DJ, Cohen ND, Larsen RN, Kingwell BA, Owen N, Dunstan DW. Frequency of Interruptions to Sitting Time: Benefits for Postprandial Metabolism in Type 2 Diabetes. Diabetes Care. 2021 Jun;44(6):1254-1263. doi: 10.2337/dc20-1410. Epub 2021 Apr 26.
- Duran AT, Friel CP, Serafini MA, Ensari I, Cheung YK, Diaz KM. Breaking Up Prolonged Sitting to Improve Cardiometabolic Risk: Dose-Response Analysis of a Randomized Crossover Trial. Med Sci Sports Exerc. 2023 May 1;55(5):847-855. doi: 10.1249/MSS.0000000000003109. Epub 2023 Jan 12.
- Wu Y, Van Gerven PWM, de Groot RHM, Eijnde BO, Winkens B, Savelberg HHCM. Effects of breaking up sitting with light-intensity physical activity on cognition and mood in university students. Scand J Med Sci Sports. 2023 Mar;33(3):257-266. doi: 10.1111/sms.14277. Epub 2022 Dec 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL86254.068.24
- CCMO, WMO (Registry Identifier: NL-OMON57014)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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