Preventing Exercise Resistance With Sedentary Interruptions

NCT06277713 | Recruiting DMC

• 1 other identifier: CME2023/069
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sedentary Behavior; Lipid Metabolism Disorder; Exercise

Keywords

Exercise; Postprandial metabolism

Outcome Measures

Primary Outcomes (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.

  360 minutes

Secondary Outcomes (2)

• Total and incremental area under the curve of glucose and insulin postprandial responses

  360 minutes

• Resting metabolic rate

  0 minute

Study Arms (3)

Exercise after prolonged sitting (SIT)

ACTIVE COMPARATOR

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; Behavioral: Sedentary

Exercise after sitting with standing breaks (WBR)

EXPERIMENTAL

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: Standing interruptions; Behavioral: Exercise bout

Non-exercise control (NEX)

OTHER

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

Interventions

Standing interruptions BEHAVIORAL

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 after sitting with standing breaks (WBR)

Exercise bout BEHAVIORAL

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).

Exercise after prolonged sitting (SIT); Exercise after sitting with standing breaks (WBR)

Sedentary BEHAVIORAL

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

Exercise after prolonged sitting (SIT); Non-exercise control (NEX)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Lipid Metabolism Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bert Op 't Eijnde, Prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bert Op 't Eijnde, Prof. dr.

CONTACT

+3211292121; bert.opteijnde@uhasselt.be

Jen Vanherle, Drs.

CONTACT

jen.vanherle@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the allocation of participants as samples will be code labeled.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: February 19, 2024
• Primary Completion: October 30, 2024
• Study Completion: July 1, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication of the results, data will become available for a duration of 25 years.
• Access Criteria: Access will be granted after motivated and reasonable request to the principal investigator.

Locations

BE (1)