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NCT Number: NCT04864028

Energy Profile and Low Intensity Activity (PROFILE)

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.

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Key information

Conditions

Healthy Behavior Sedentary Behavior

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Other

15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling

Primary outcomes

  1. 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)

Secondary outcomes

  1. physical activity level (ActiGraph)

    Time frame: during the 7 days following the experimental session

    using acceleometry device (ActiGraph Gt3x)

  2. physical activity level (ActivPAL)

    Time frame: during the 7 days following the experimental session

    using accelerometry (ActivPAL)

  3. Body composition : fat mass and fat free mass

    Time frame: day 0

    body composition will be assessed by bioelectrical impedance device (TANITA MC-780MA)

  4. upper limb strength

    Time frame: during the experimental session after energy expenditure assessment (Day 1)

    will be assessed with handgrip for upper limb muscle

  5. aerobic fitness

    Time frame: during the experimental session after energy expenditure assessment (day 1)

    will be assessed with the Step Test 6 minutes

  6. lower limb strength

    Time frame: during the experimental session after energy expenditure assessment (day1)

    will be assessed with isokinetic dynamometer

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Laboratory AME2P UR3533
  • Université d'Auvergne

Registry information

Official study title

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

Acronym: PROFILE

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 28, 2021
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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