- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864028
Energy Profile and Low Intensity Activity (PROFILE) (PROFILE)
Energy Adaptations During Active Workstation Use: Strategy for Individualization of Active Desk Programs
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- CHU de Clermont-Ferrand
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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)
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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)
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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
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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)
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will be assessed with isokinetic dynamometer
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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.
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during the experimental session before energy expenditure assessment (day 1)
|
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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.
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during the experimental session before energy expenditure assessment (day 1)
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Collaborators and Investigators
Investigators
- Principal Investigator: Martine DUCLOS, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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