HealthyPROFILENCT04864028
Energy Profile and Low Intensity Activity (PROFILE)
A study testing physical activity in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2021to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- physical activity
- Keywords
- Active workstation, cycling, energy expenditure, sedentary
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityOther
15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Experimental | Not described Receives: Other: physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: change from baseline to the experimental visit (Day 1)
Secondary outcomes (8)
physical activity level (ActiGraph)
using acceleometry device (ActiGraph Gt3x)
Measured: during the 7 days following the experimental session
physical activity level (ActivPAL)
using accelerometry (ActivPAL)
Measured: during the 7 days following the experimental session
Body composition : fat mass and fat free mass
body composition will be assessed by bioelectrical impedance device (TANITA MC-780MA)
Measured: day 0
upper limb strength
will be assessed with handgrip for upper limb muscle
Measured: during the experimental session after energy expenditure assessment (Day 1)
aerobic fitness
will be assessed with the Step Test 6 minutes
Measured: during the experimental session after energy expenditure assessment (day 1)
lower limb strength
will be assessed with isokinetic dynamometer
Measured: during the experimental session after energy expenditure assessment (day1)
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.
Measured: during the experimental session before energy expenditure assessment (day 1)
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.
Measured: during the experimental session before energy expenditure assessment (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start25 May 2021
- Primary completion12 Dec 2022
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, Université d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Martine Duclos, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864028
- Sponsor's protocol ID
- RBHP 2020 DUCLOS 3
- Other IDs
- 2020-A03311-38
- Acronym
- PROFILE
- Status last verified
- Jul 2023
- First submitted
- 9 Apr 2021
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Adaptations During Active Workstation Use: Strategy for Individualization of Active Desk Programs
- ClinicalTrials.gov ID
- NCT04864028
- Acronym / sponsor ID
- PROFILE / RBHP 2020 DUCLOS 3
- Conditions
- Healthy
- Keywords
- Active workstation, cycling, energy expenditure, sedentary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, Université d'Auvergne
- Study start
- 25 May 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Experimental | Other: physical activity |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling | Other | Healthy volunteer |
Primary outcome
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)
8 secondary outcomes
physical activity level (ActiGraph)
Time frame: during the 7 days following the experimental session
physical activity level (ActivPAL)
Time frame: during the 7 days following the experimental session
Body composition : fat mass and fat free mass
Time frame: day 0
upper limb strength
Time frame: during the experimental session after energy expenditure assessment (Day 1)
aerobic fitness
Time frame: during the experimental session after energy expenditure assessment (day 1)
lower limb strength
Time frame: 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)
eating profile with TFEQ questionnaire (Three-Factor Eating Questionnaire)
Time frame: during the experimental session before energy expenditure assessment (day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Duclos principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy expenditure (time frame: change from baseline to the experimental visit (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023; AzTrials last refreshed its copy on 4 Nov 2026.