Sedentary BehaviorNCT05709379
Effects of Interrupting Sedentary Behavior With High - or Low Intensity PA on CVD - and Cardiometabolic Riskfactors, and Cognitive Performance.
A study testing Sedentary behavior in people with Sedentary Behavior and Physical Activity, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
The knowledge gap on sedentary behavior and sedentary breaks includes whether detrimental effects of sedentary behavior can be fully attenuated by 1.) sedentary breaks 2.) physical activity or 3.) both combined. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Physical Activity
- What is being tested?
- Sedentary behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jan 2023to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Predominantly sedentary occupation.
- Physical activity: equal or less tham 150 minutes /week
- Nonobese. Central adiposity: Waist circumference equal or less than 102 cm for men and equal or less than < 88 cm for women. BMI < 30 km·m2
Who cannot join
- Shift-work
- Smoking
- Pregnancy
- Current use of medication, except from hormonal contraceptives.
- No presence of any co-morbidity (e.g. diabetes type 2, cardiovascular or cardiorespiratory disease, or other conditions known to affect carbohydrate and lipid metabolism - thyroid-, -liver or kidney).
- Systolic /diastolic resting blood pressure: > 140/90 mmHg
- Fasting blood glucose concentration: > 6.1 mmol/L
- Abnormal total cholesterol, LDL, LDL or triglyceride concentrations (> 50% above recommendations)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Interrupting Sedentary Behavior With High - or Low Intensity Physical Activity on Cardiovascular - and Cardiometabolic Riskfactors, and Cognitive Performance.
The knowledge gap on sedentary behavior and sedentary breaks includes whether detrimental effects of sedentary behavior can be fully attenuated by 1.) sedentary breaks 2.) physical activity or 3.) both combined. Specifically, when breaking sedentary time which physical activity pattern- and intensity modifies the negative effects of sedentary behavior on glucose- and lipid metabolism? This lack of quantitative evidence calls for prospective experimental studies investigating the physiological and biological impacts of sedentary behavior, as well as the effectiveness of different strategies to reduce sedentary time. Thus, quantifying effects of the intensity, frequency, volume of sedentary breaks and/or physical activity on predefined outcomes is of importance.
Aims:
Read more
Our primary aims are to investigate the effects of breaking up sedentary time on glucose- and lipid metabolism and thus examine whether physical activity intensity breaks during sedentary breaks matter. Specifically, the aims of the PhD-project are to provide knowledge on the following questions:
- How does high- or low physical activity intensity sedentary breaks acutely influence glucose- and lipid metabolism under iso-caloric conditions?
Read the detailed description
The participants will undergo 3 different trial conditions of which all are iso-caloric, but with different intensities when executing physical activity (PA) by treadmill walking corresponding to 25-30% or 80-85%, respectively, of their individual VO2max/peak values. PA intensities are estimated from the individual's pre-test. The trial-conditions are iso-caloric, and tailored to each individual's energy expenditure. This study has a is randomized cross-over design. If found eligible from step 1 and 2 in the inclusion process, participants will be invited to a final screening day in our lab. Eligible participants then consenting to joining the study will continue on to 3 trial days. Due to possible acute rise in insulin for up to 48 hours, a 5-14 day washout period between trials will be used to avoid carryover effects. In the washout periods between experimental conditions the participants will resume their habitual life activities and behaviors, i.e., diet and physical activity patterns. However, from visit 2, during washout the participants will wear accelerometers (ActiGraph GTX3+, Pensacola, FL) during waking hours to objectively measure sedentary time and physical activity for 7 consecutive days after each trial. Average sedentary time (hour/day) and time spent in , light-, moderate- and vigorous physical activity intensity (min/day) will be derived. During the main trial days, the participants may read or work on a personal computer during the sedentary time in the respective trial conditions. The sample size calculations with glucose as the primary outcome, are based on the study by Dunstan et al. (2012). They estimated that 19 paired observations were needed to secure a power of 0.90 in order to detect the smallest expected effect size between the interventions, when using a two-tailed test with a significance level of 5%. To account for the possibility of dropouts the sample size in the present project is set to recruit 30 participants, with 25 participants completing the trials, and thus planning for 80% power
- Conditions
- Sedentary Behavior, Physical Activity
- Being tested
- Sedentary behavior
- Keywords
- Sedentary behavior, Physical Activity, Cardiometabolic, Cardiovascular, Sitting
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary behaviorBehavioural
Interrupting sitting with walking/jogging at either high -or low physical activity intensity.
| Study group | Role | What they receive |
|---|---|---|
| Control trial | Experimental | Sitting from 8 am until 3pm. Receives: Behavioral: Sedentary behavior |
| High intensity sedentary breaks | Experimental | Physical activity on 80-85% of individual VO2max every hour. Modality: Hill walking/jogging on treadmill. Receives: Behavioral: Sedentary behavior |
| Low intensity sedentary breaks | Experimental | Physical activity on 25-30% of individual VO2max every hour. Modality: Hill walking on treadmill. Receives: Behavioral: Sedentary behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total (tAUC)- and incremental areas under the curve (iAUC) for glucose
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition
Measured: The iAUC for glucose will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
Secondary outcomes (5)
tAUC and iAUC analyses for insulin
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition
Measured: The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
tAUC and iAUC analyses for c-peptide
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition
Measured: The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
tAUC and iAUC analyses for triglycerides
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition
Measured: The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
tAUC and iAUC analyses for lipids
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition
Measured: The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
Cognitive function and performance
Cognitive function tasks will be performed, and cognitive function will be assessed by Trail making test A and B, and Stroop-test.
Measured: The cognitive measures will be performed during the procedure (at approx 400 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start2 Jan 2023
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be conducted as randomized controlled crossover trials involving 3 different trial conditions in each of the studies. Randomization will be stratified based on sex. The order of trials will be assigned randomly by a third party using a computer software. After pre-testing and familiarization (visit 1), the participants will undergo 3 different trial conditions of 7 hours. The trials are all iso-caloric, but with different intervals of sitting and executing moderate physical activity by treadmill walking/running corresponding to 25-30% or 80-85%, repectively of their individual VO2max values, estimated from the individual's pre-test. Blood samples will be taken and blood pressure measured every 30 minutes. The visits for main testing will be separated by a washout period of minimum 5 days, and women will be tested in the follicular phase.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Jostein Steene-Johannessen, Norwegian School of Sport Sciences
- Investigators
- Jostein Steene-Johennessen, Professor, Principal investigator, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709379
- Sponsor's protocol ID
- GENSED#2
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interrupting Sedentary Behavior With High - or Low Intensity Physical Activity on Cardiovascular - and Cardiometabolic Riskfactors, and Cognitive Performance.
- ClinicalTrials.gov ID
- NCT05709379
- Acronym / sponsor ID
- GENSED#2
- Conditions
- Sedentary Behavior, Physical Activity
- Keywords
- Sedentary behavior, Physical Activity, Cardiometabolic, Cardiovascular, Sitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 2 Feb 2023 (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.
The knowledge gap on sedentary behavior and sedentary breaks includes whether detrimental effects of sedentary behavior can be fully attenuated by 1.) sedentary breaks 2.) physical activity or 3.) both combined. Specifically, when breaking sedentary time which physical activity pattern- and intensity modifies the negative effects of sedentary behavior on glucose- and lipid metabolism? This lack of quantitative evidence calls for prospective experimental studies investigating the physiological and biological impacts of sedentary behavior, as well as the effectiveness of different strategies to reduce sedentary time. Thus, quantifying effects of the intensity, frequency, volume of sedentary breaks and/or physical activity on predefined outcomes is of importance.
Aims:
Our primary aims are to investigate the effects of breaking up sedentary time on glucose- and lipid metabolism and thus examine whether physical activity intensity breaks during sedentary breaks matter. Specifically, the aims of the PhD-project are to provide knowledge on the following questions:
- How does high- or low physical activity intensity sedentary breaks acutely influence glucose- and lipid metabolism under iso-caloric conditions?
Detailed description
The participants will undergo 3 different trial conditions of which all are iso-caloric, but with different intensities when executing physical activity (PA) by treadmill walking corresponding to 25-30% or 80-85%, respectively, of their individual VO2max/peak values. PA intensities are estimated from the individual's pre-test. The trial-conditions are iso-caloric, and tailored to each individual's energy expenditure. This study has a is randomized cross-over design. If found eligible from step 1 and 2 in the inclusion process, participants will be invited to a final screening day in our lab. Eligible participants then consenting to joining the study will continue on to 3 trial days. Due to possible acute rise in insulin for up to 48 hours, a 5-14 day washout period between trials will be used to avoid carryover effects. In the washout periods between experimental conditions the participants will resume their habitual life activities and behaviors, i.e., diet and physical activity patterns. However, from visit 2, during washout the participants will wear accelerometers (ActiGraph GTX3+, Pensacola, FL) during waking hours to objectively measure sedentary time and physical activity for 7 consecutive days after each trial. Average sedentary time (hour/day) and time spent in , light-, moderate- and vigorous physical activity intensity (min/day) will be derived. During the main trial days, the participants may read or work on a personal computer during the sedentary time in the respective trial conditions. The sample size calculations with glucose as the primary outcome, are based on the study by Dunstan et al. (2012). They estimated that 19 paired observations were needed to secure a power of 0.90 in order to detect the smallest expected effect size between the interventions, when using a two-tailed test with a significance level of 5%. To account for the possibility of dropouts the sample size in the present project is set to recruit 30 participants, with 25 participants completing the trials, and thus planning for 80% power
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study will be conducted as randomized controlled crossover trials involving 3 different trial conditions in each of the studies. Randomization will be stratified based on sex. The order of trials will be assigned randomly by a third party using a computer software. After pre-testing and familiarization (visit 1), the participants will undergo 3 different trial conditions of 7 hours. The trials are all iso-caloric, but with different intervals of sitting and executing moderate physical activity by treadmill walking/running corresponding to 25-30% or 80-85%, repectively of their individual VO2max values, estimated from the individual's pre-test. Blood samples will be taken and blood pressure measured every 30 minutes. The visits for main testing will be separated by a washout period of minimum 5 days, and women will be tested in the follicular phase.
| Arm | Type | Receives |
|---|---|---|
| Control trial | Experimental | Behavioral: Sedentary behaviorSitting from 8 am until 3pm. |
| High intensity sedentary breaks | Experimental | Behavioral: Sedentary behaviorPhysical activity on 80-85% of individual VO2max every hour. Modality: Hill walking/jogging on treadmill. |
| Low intensity sedentary breaks | Experimental | Behavioral: Sedentary behaviorPhysical activity on 25-30% of individual VO2max every hour. Modality: Hill walking on treadmill. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Predominantly sedentary occupation.
- Physical activity: equal or less tham 150 minutes /week
- Nonobese. Central adiposity: Waist circumference equal or less than 102 cm for men and equal or less than < 88 cm for women. BMI < 30 km·m2
Key exclusion criteria (8 listed)
- Shift-work
- Smoking
- Pregnancy
- Current use of medication, except from hormonal contraceptives.
- No presence of any co-morbidity (e.g. diabetes type 2, cardiovascular or cardiorespiratory disease, or other conditions known to affect carbohydrate and lipid metabolism - thyroid-, -liver or kidney).
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 |
|---|---|---|
| Sedentary behaviorInterrupting sitting with walking/jogging at either high -or low physical activity intensity. | Behavioural | Control trial, High intensity sedentary breaks, Low intensity sedentary breaks |
Primary outcome
Total (tAUC)- and incremental areas under the curve (iAUC) for glucose
Time frame: The iAUC for glucose will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition
5 secondary outcomes
tAUC and iAUC analyses for insulin
Time frame: The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
tAUC and iAUC analyses for c-peptide
Time frame: The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
tAUC and iAUC analyses for triglycerides
Time frame: The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
tAUC and iAUC analyses for lipids
Time frame: The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
Cognitive function and performance
Time frame: The cognitive measures will be performed during the procedure (at approx 400 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jostein Steene-Johennessen, Professor principal investigator
Norwegian School of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary behavior in people with Sedentary Behavior and Physical Activity, run by Norwegian School of Sport Sciences at 1 site in Norway.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 21 Jan 2026. 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 Norway. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total (tAUC)- and incremental areas under the curve (iAUC) for glucose (time frame: The iAUC for glucose will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.