Energy Profile and Low Intensity Activity (PROFILE)

Healthy Clinical Trial

— PROFILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864028
• Other study ID #: RBHP 2020 DUCLOS 3
• Secondary ID: 2020-A03311-38
• Status: Completed
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: June 29, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 29, 2023
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• physical activity
15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Laboratory AME2P UR3533, Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	energy expenditure	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	physical activity level (ActiGraph)	using acceleometry device (ActiGraph Gt3x)	during the 7 days following the experimental session
Secondary	physical activity level (ActivPAL)	using accelerometry (ActivPAL)	during the 7 days following the experimental session
Secondary	Body composition : fat mass and fat free mass	body composition will be assessed by bioelectrical impedance device (TANITA MC-780MA)	day 0
Secondary	upper limb strength	will be assessed with handgrip for upper limb muscle	during the experimental session after energy expenditure assessment (Day 1)
Secondary	aerobic fitness	will be assessed with the Step Test 6 minutes	during the experimental session after energy expenditure assessment (day 1)
Secondary	lower limb strength	will be assessed with isokinetic dynamometer	during the experimental session after energy expenditure assessment (day1)
Secondary	eating profile with DEBQ questionnaire (Dutch Eating Behavior Questionnaire)	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)
Secondary	eating profile with TFEQ questionnaire (Three-Factor Eating Questionnaire)	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)