Energy Profile and Low Intensity Activity (PROFILE) (PROFILE)

July 7, 2023 updated by: University Hospital, Clermont-Ferrand

Energy Adaptations During Active Workstation Use: Strategy for Individualization of Active Desk Programs

The recent literature has highlighting the importance of the time of SB and the level of physical activity (PA) as predictors of metabolic cardio risks. Now, sedentary lifestyles are well recognized as one of the causes of mortality. As with physical activity, a dose-response relationship appears to exist: mortality would increase with time spent in sedentary behaviors. However, this relationship would not be linear: the more the daily sitting time increases, the more the consequences on mortality are important. It is now well demonstrated that time spent in sedentary adult behaviour finds primarily its origin in the work, characterized by prolonged and uninterrupted periods of sitting. Many strategies have been settled to break the prolonged sitting time. The most promising one seem to be the use of active workstations (standing, walking, cycling, stepping) because they reduce sedentary time at work and increase physical activity with positive effects on the global health. However inter variability in energy response have been identified during a sit to stand allocation with subject "savers" profile showing an increase in energy expenditure while others categorized as "non-savers" increased significantly their energy expenditure between sitting and standing position. As others active workstation strategies exist, this study aim to first, better characterize energy response to posture and activity allocation (15min sit-15min stand-15min sit-15min low intensity cycling), secondly to identify parameters that could explain different energy profile.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subject will have an inclusion visit during a medical consultation where the eligibility criteria to participate to this study will be checked.

During a second experimental visit, subjects will have to take a calibrated breakfast. Three hours after the breakfast, body composition will be assessed and energy expenditure and substrates oxidation will be measured with an indirect calorimetry device during 15min in a sitting position fallowed by 15min in standing position , 15min in a sitting position and 15min of low intensity cycling with a cycling desk.

Then subjects will underwent physical capacity test :

  • 6min step test
  • Handgrip test
  • lower limb strength test Finally, subjects will be equipped with accelerometer and inclinometer device they will need to wore during 7 days.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteer, male or female, between 18 and 61 years old
  • Body mass index > 18,5 kg/m2 and ≤ 25 kg/m2
  • Able to provide informed consent to research participation
  • Registered in the French social security system

Exclusion Criteria:

  • Subject using a sit-to-stand office desk or a swiss ball
  • Contact jobs (face-to-face with people)
  • Pregnant or breastfeeding women
  • Medical or surgical history determined by principal investigator to be not compatible with the study
  • Subject with cardiorespiratory and/or osteo-articular disorders limiting their ability to perform physical tests or the use of active offices
  • Subject with type 1 or type 2 diabetes treated with insulin
  • Subject with progressive cardiovascular or neoplastic disease.
  • Subject with a major infection within 3 months of inclusion.
  • Subject with known neuromuscular pathology: myopathy, myasthenia, rhabdomyolysis, paraplegia, hemiplegia
  • Subject with chronic or acute inflammatory pathology 3 months prior to inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteer
15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
energy expenditure
Time Frame: change from baseline to the experimental visit (Day 1)
Using an indirect calorimetry device change in energy expenditure will be assed during the 1h posture /activity allocation (15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling)
change from baseline to the experimental visit (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical activity level (ActiGraph)
Time Frame: during the 7 days following the experimental session
using acceleometry device (ActiGraph Gt3x)
during the 7 days following the experimental session
physical activity level (ActivPAL)
Time Frame: during the 7 days following the experimental session
using accelerometry (ActivPAL)
during the 7 days following the experimental session
Body composition : fat mass and fat free mass
Time Frame: day 0
body composition will be assessed by bioelectrical impedance device (TANITA MC-780MA)
day 0
upper limb strength
Time Frame: during the experimental session after energy expenditure assessment (Day 1)
will be assessed with handgrip for upper limb muscle
during the experimental session after energy expenditure assessment (Day 1)
aerobic fitness
Time Frame: during the experimental session after energy expenditure assessment (day 1)
will be assessed with the Step Test 6 minutes
during the experimental session after energy expenditure assessment (day 1)
lower limb strength
Time Frame: during the experimental session after energy expenditure assessment (day1)
will be assessed with isokinetic dynamometer
during the experimental session after energy expenditure assessment (day1)
eating profile with DEBQ questionnaire (Dutch Eating Behavior Questionnaire)
Time Frame: during the experimental session before energy expenditure assessment (day 1)
the questionnaire will identify with a scale (items to rank between never and always) three major factors influencing eating behavior "emotional , restrained and external eating". For all items score goes from 0 to 5pts and the lower score the better/healthier.
during the experimental session before energy expenditure assessment (day 1)
eating profile with TFEQ questionnaire (Three-Factor Eating Questionnaire)
Time Frame: during the experimental session before energy expenditure assessment (day 1)
the questionnaire will identify with a scale (items to rank between never and always) three major eating profiles (cognitive restraint, disinhibition, hunger). For Items 1 to 16 score goes from 4 to 1pts, from items 17-21 score goes from 1 to 4 pts. Global score is calculated the lower the healthier.
during the experimental session before energy expenditure assessment (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Martine DUCLOS, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2021

Primary Completion (Actual)

December 12, 2022

Study Completion (Actual)

June 29, 2023

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • RBHP 2020 DUCLOS 3
  • 2020-A03311-38 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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