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Sedentary BehaviorPERSINCT06277713

Preventing Exercise Resistance With Sedentary Interruptions

A study testing Standing interruptions, Exercise bout and Sedentary in people with Sedentary Behavior and Lipid Metabolism Disorder, run by Hasselt University at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this randomised cross-over trial is to learn about the interaction between sedentary behaviour throughout the day and the metabolic effect of an exercise bout on that same day in office workers with an increased risk for chronic disease. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
What is being tested?
Standing interruptions, Exercise bout and Sedentary
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteBelgium
Study dates
19 Feb 2024to 1 Jul 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 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • between 30 and 65 years old,
  • primarily work in an office environment for at least 0.75 full time equivalents,
  • sedentary (on average >9h of sedentary time per day, assessed objectively),
  • at an increased risk for disturbances in lipid profile (assessed with fingerstick (Analox®) total cholesterol >200 mg/dL or fingerstick triglycerides >150 mg/dL),
  • written informed consent to participate in the study.

Who cannot join

  • medical conditions precluding physical activity (PA) participation,
  • abusive alcohol intake (>20 units/week),
  • pregnant or intention to become pregnant,
  • change in dietary habits or weight loss (>2kg) in the last month before the study,
  • a diagnosis of cardiometabolic diseases such as diabetes mellitus or cardiovascular diseases.

Trial locations and contacts

1 site in 1 country.

Bert Op 't Eijnde, Prof. dr. contact

+3211292121

bert.opteijnde@uhasselt.be

Jen Vanherle, Drs. contact

jen.vanherle@uhasselt.be

Belgium1 site, 1 recruiting
  • Hasselt University

    Diepenbeek, Limburg, 3590

    Bert Op 't Eijnde, Prof. dr., +3211292121, bert.opteijnde@uhasselt.be

    Jen Vanherle, Drs., jen.vanherle@uhasselt.be

    Recruiting

Other trials in Belgium

About this study

The goal of this randomised cross-over trial is to learn about the interaction between sedentary behaviour throughout the day and the metabolic effect of an exercise bout on that same day in office workers with an increased risk for chronic disease.

The main question this study aims to answer is if the lipid-lowering effects of an exercise bout can be more pronounced by implementing alternations between a seated and a standing working position throughout the day.

Read more

Participants will be asked to:

  • Complete three intervention periods for a duration of 2 days at their workplace,
  • Attend a supervised training session (60min) at the research facility at the end of each intervention period,
  • Attend three assessment days at the research facility where postprandial metabolism will be evaluated after a standardised meal test.
Read the detailed description

The World Health Organisation recently published guidelines with physical activity recommendations that serve to promote healthy lifestyles and thus can help reduce the risk of chronic diseases. In these, they also included for the first time that sedentary behaviour (e.g. sedentary work, driving a car, ...) should be reduced as much as possible since there are clear links between a sedentary lifestyle and negative health effects.

However, WHO also indicates that more research is needed to investigate the health effects of interactions between planned physical activity and sedentary behaviour. This is of even greater importance as there are now some studies indicating that the acute effects of an exercise session are greatly reduced when combined with prolonged sitting throughout the day. This new insight has been labelled as sitting-induced exercise resistance. This study aims to investigate whether it is possible to reduce sitting behaviour by moving more and optimally preserve the effects of a training session.

This study will evaluate how the combination of sitting behaviour and a training session affects certain health parameters. Indeed, prolonged sitting leads to an increased risk of poor cardiometabolic health and consequently an increased risk of developing conditions such as diabetes and cardiovascular disease. Recent research shows that interrupting prolonged sitting can largely prevent some adverse effects on cardiometabolic health. Furthermore, it also shows that the positive effects of an exercise session are greatly reduced when this workout is scheduled on a day that was otherwise spent mainly sitting.

Previous research shows that interrupting sitting behaviour after 20 minutes by short-term (2min) exercise at light intensity would be optimal to improve glucose metabolism. However, this pattern is not very practical to apply in a work environment. For this, installing sit-stand desks could be a solution, as it seems that introducing such sit-stand desks in a work environment could cost-effectively reduce the risk of developing a number of chronic diseases by reducing sitting time. In this study, the effects on postprandial lipemia of reducing prolonged sitting time by introducing sit-stand desks and an exercise bout will be evaluated.

Being tested
Standing interruptions, Exercise bout, Sedentary
Keywords
Exercise, Postprandial metabolism
Medical subject headings
Sedentary Behavior, Lipid Metabolism Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standing interruptionsBehavioural

    A mobile sit-to-stand desk will be installed at the workplace and participants are instructed to alternate their working position every 30 minutes during two working days (8h).

  • Exercise boutBehavioural

    Participants will perform a continuous aerobic exercise bout for a duration of 60 minutes at a moderate intensity, which is defined as 60% of their maximal oxygen uptake (VO2max).

  • SedentaryBehavioural

    Participants are instructed to minimise any behaviour that is not sedentary during two working days (8h).

Study groups in NCT06277713
Study groupRoleWhat they receive
Exercise after prolonged sitting (SIT)Active comparatorAll participants will be instructed to complete two working days (8h) where they perform seated desk-work throughout the day. At the end of the second day, they will perform a supervised exercise bout at the research facility.
Receives: Behavioral: Exercise bout; Behavioral: Sedentary
Exercise after sitting with standing breaks (WBR)ExperimentalAll participants will be instructed to complete two working days (8h) where they alternate seated desk-work with standing desk-work hourly throughout the day. At the end of the second day, they will perform a supervised exercise bout at the research facility.
Receives: Behavioral: Standing interruptions; Behavioral: Exercise bout
Non-exercise control (NEX)OtherIn this control group all participants will be instructed to complete two working days (8h) where they perform seated desk-work throughout the day.
Receives: Behavioral: Sedentary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total and incremental area under the curve of postprandial response in lipid metabolism

    Lipid levels will be assessed at nine different timepoints (0 minutes, 30 minutes, 60 minutes, 120 minutes, 180 minutes, 210 minutes, 240 minutes, 300 minutes and 360 minutes). Postprandial responses will be defined as the area under the curve (AUC) over the three-hour period after each test meal and the cumulative AUC of the whole time frame.

    Measured: 360 minutes

Secondary outcomes (2)
  1. Total and incremental area under the curve of glucose and insulin postprandial responses

    Glucose and insulin levels will be assessed at nine different timepoints (0 minutes, 30 minutes, 60 minutes, 120 minutes, 180 minutes, 210 minutes, 240 minutes, 300 minutes and 360 minutes). Postprandial responses will be defined as the area under the curve (AUC) over the three-hour period after each test meal and the cumulative AUC of the whole time frame.

    Measured: 360 minutes

  2. Resting metabolic rate

    Resting metabolic rate will be determined by indirect calorimetry on the morning of each assessment day.

    Measured: 0 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start19 Feb 2024
  3. Primary completion30 Oct 2024 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

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
Model description
Participants will follow three regimes of 2 days each including a sedentary control, a sedentary with exercise and a standing breaks with exercise regimen. The sequence of the regimens will be randomised. Each regimen will be followed by a minimum wash-out period of 7 days during which subjects will continue their normal lifestyle. We will use a balanced design with 6 randomisation blocks (ABC, ACB, BAC,BCA, CAB, CBA). The randomisation will be computer-generated and allocation will be determined by a member of the research team drawing a sealed, non-translucent envelop with herein written the scheme.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277713
Sponsor's protocol ID
CME2023/069
Acronym
PERSI
Status last verified
Mar 2024
First submitted
19 Feb 2024
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: In a restriced access depositry. Personal data is sensitive data and is thus protected in a restricted access repository. During the project these data will be pseudonymized and after completion of the project data will be anonymized and the pseudonymization key will be destroyed. Access can be granted by the primary investigator who holds the pseudonymization key in a restricted folder during the project.

Publications

  • Vanherle JLP, Franssen WMA, Nieste I, O Eijnde B. Sit-To-Stand Breaks to Optimize Cardiometabolic Health Effects Following Exercise in Sedentary Adults With Dyslipidaemia: A Randomized Crossover Trial. Scand J Med Sci Sports. 2026 Jul;36(7):e70336. doi: 10.1111/sms.70336.

    PubMed 42400437

Questions about this trial

What is this clinical trial studying?

A study testing Standing interruptions, Exercise bout and Sedentary in people with Sedentary Behavior and Lipid Metabolism Disorder, run by Hasselt University at 1 site in Belgium.

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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Mar 2024. 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 Belgium. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bert Op 't Eijnde, Prof. dr. (+3211292121, bert.opteijnde@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total and incremental area under the curve of postprandial response in lipid metabolism (time frame: 360 minutes). 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 NCT06277713, 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 4 Mar 2024.

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PERSI Clinical Trial NCT06277713 | AzTrials