Preventing Exercise Resistance With Sedentary Interruptions (PERSI)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Sedentary Behavior; Lipid Metabolism Disorder
• Intervention / Treatment: Behavioral: Exercise bout; Behavioral: Sedentary; Behavioral: Standing interruptions

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bert Op 't Eijnde, Prof. dr.; Phone Number: +3211292121; Email: bert.opteijnde@uhasselt.be
• Study Contact Backup: Name: Jen Vanherle, Drs.; Email: jen.vanherle@uhasselt.be

Study Locations

• Belgium
  • Limburg
    • Diepenbeek, Limburg, Belgium, 3590
      • Recruiting
      • Hasselt University
      • Contact: Bert Op 't Eijnde, Prof. dr.; Phone Number: +3211292121; Email: bert.opteijnde@uhasselt.be
      • Contact: Jen Vanherle, Drs.; Email: jen.vanherle@uhasselt.be
      • Principal Investigator: Bert Op 't Eijnde, Prof. dr.
      • Sub-Investigator: Jen Vanherle, Drs.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise after prolonged sitting (SIT); All 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.	Behavioral: Exercise bout; 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).; Behavioral: Sedentary; Participants are instructed to minimise any behaviour that is not sedentary during two working days (8h).
Experimental: Exercise after sitting with standing breaks (WBR); All 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.	Behavioral: Exercise bout; 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).; Behavioral: Standing interruptions; 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).
Other: Non-exercise control (NEX); In this control group all participants will be instructed to complete two working days (8h) where they perform seated desk-work throughout the day.	Behavioral: Sedentary; Participants are instructed to minimise any behaviour that is not sedentary during two working days (8h).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	360 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	360 minutes
Resting metabolic rate	Resting metabolic rate will be determined by indirect calorimetry on the morning of each assessment day.	0 minute

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Bert Op 't Eijnde, Prof. dr., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Postprandial metabolism
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: CME2023/069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After publication of the results, data will become available for a duration of 25 years.
• IPD Sharing Access Criteria: Access will be granted after motivated and reasonable request to the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No