Clinical trial NCT04153214: Effects of Cycling Workstation on Cardiometabolic Health for Workers With an Office-sitting Desk (REMOVE)
Official title: Effects of Cycling Workstation on Cardiometabolic Health for Workers With an Office-sitting Desk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Behavior
Keywords: Cardiometabolic health
Sedentary Behavior
Active workstation
Cycling desk
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Laboratoire AME2P - Unversité Clermont Auvergne
First posted: 2019-11-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The recent literature has highlighting the importance of the time of inactivity 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 (treadmill, cycling, stepping) because they reduce sedentary time at work and increase physical activity with positive effects on the global health. If active workstations have demonstrated their effectiveness with overweight or obese people by increasing daily energy expenditure, their interest in prevention in normal weight people is less known. In addition, the long-term effectiveness of a program of reactivation by active workstation on biological parameters, quantitative and qualitative time of sedentary behaviour (duration, number of breaks) and physical fitness was not assessed.

The main objective of this project is to study the effects of the use of a cycling workstation for 60 minutes per day (30 minutes twice a day) for 3 months among professionals with an office-sitting desk on overall quantity of physical activity time (work and non-work) and sedentary time.

Detailed description: Subject will have a pre-inclusion visit during a medical consultation where the eligibility criteria to participate to this study will be checked.

After the inclusion of subject and their agreements to participate to the study, they will know in which group they are :

* Group who performs 30minutes twice a working day from day 1 to day 180 (interventional)
* Group who performs 30minutes twice a working day from day 90 to day 180 (control)

They will have evaluation at three different times : T0 (Day 1), T1 (Day 90), T2 (Day 180). The evaluation will evaluate :

* overall quantity and quality of physical activity time (work and non-work) and sedentary time
* Body composition
* Biological parameters
* Physical fitness
* Psychological parameters At the end of the protocol, there will be an assessment of the obstacles or motivations to this program.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer, male or female, between 18 and 61 years old
* Body mass index \> 18,5 kg/m2 and ≤ 35 kg/m2
* More than 0.8 full time equivalent hours (FTE) with 75% of this time in a sitting position
* Able to provide informed consent to research participation
* Registered in the French social security system

Exclusion Criteria:

* Work involving multiple periods of sitting interruptions \>1 minute
* Subject using a sit-to-stand office desk or a swiss ball
* Sports activity \> 2.5 hours/week
* 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
* Subject treated by beta-blocker
* Subject diagnosed and/or treated for schizophrenia, bipolar disorders, major depression
* Subject treated, or having stopped treatment for less than 3 months prior to inclusion, by corticosteroids, immunosuppressant, anabolic, growth hormone.
* Subject with unstable psychiatric condition
* Significant alcohol consumption (\> 2-3 drinks per day depending on gender) or presence of substance abuse.
* Unable to walk or pedal 45 minutes in a row
* Subject who is excluded from another study or who received more than €4,500 in the year following his participation in clinical studies
* Subject deprived of their liberty by judicial or administrative decision
* Refusal to sign written consent to participate
* Subject participating in another study

Primary outcomes:
measure: effects of the use of a cycling Workstation for 60 minutes per day (30 minutes twice a day) for 3 months among professionals with an office-sitting desk on overall quantity of physical activity time (work and non-work) and sedentary time
timeFrame: month 3
Secondary outcomes:
measure: Body composition
timeFrame: day 90
measure: Body composition
timeFrame: day 180
measure: Body composition
timeFrame: day 1
measure: Biological parameters - insulin
timeFrame: Day 1
measure: Biological parameters - insulin
timeFrame: Day 90
measure: Biological parameters - insulin
timeFrame: Day 180
measure: Biological parameters - glucose
timeFrame: Day 1
measure: Biological parameters - glucose
timeFrame: Day 90
measure: Biological parameters - glucose
timeFrame: Day 180
measure: Biological parameters - triglycerides
timeFrame: Day 1
measure: Biological parameters - triglycerides
timeFrame: Day 90
measure: Biological parameters - triglycerides
timeFrame: Day 180
measure: Biological parameters - cholesterol
timeFrame: Day 1
measure: Biological parameters - cholesterol
timeFrame: Day 90
measure: Biological parameters - cholesterol
timeFrame: Day 180
measure: Biological parameters - CRP
timeFrame: Day 1
measure: Biological parameters - CRP
timeFrame: Day 90
measure: Biological parameters - CRP
timeFrame: Day 180
measure: Biological parameters - anandamide
timeFrame: Day 1
measure: Biological parameters - anandamide
timeFrame: Day 90
measure: Biological parameters - anandamide
timeFrame: Day 180
measure: Psychological assessment
timeFrame: Day 1
measure: Psychological assessment
timeFrame: Day 90
measure: Psychological assessment
timeFrame: Day 180
measure: Resting metabolic rate
timeFrame: Day 1
measure: Resting metabolic rate
timeFrame: Day 90
measure: Resting metabolic rate
timeFrame: Day 180
measure: Physical capacity
timeFrame: Day 1
measure: Physical capacity
timeFrame: Day 90
measure: Physical capacity
timeFrame: Day 180
measure: Muscle Strength
timeFrame: Day 1
measure: Muscle Strength
timeFrame: Day 90
measure: Muscle Strength
timeFrame: Day 180
measure: Quality of the time spend to physical activities and sedentary behaviour
timeFrame: Day 1
measure: Quality of the time spend to physical activities and sedentary behaviour
timeFrame: Day 90
measure: Quality of the time spend to physical activities and sedentary behaviour
timeFrame: Day 180
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Martine Duclos
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guirado T, Metz L, Pereira B, Brun C, Birat A, Boscaro A, Bergouignan A, Thivel D, Duclos M. A 12-Week Cycling Workstation Intervention Improves Cardiometabolic Risk Factors in Healthy Inactive Office Workers. J Occup Environ Med. 2022 Aug 1;64(8):e467-e474. doi: 10.1097/JOM.0000000000002583. Epub 2022 Jun 11.
citation: Guirado T, Metz L, Pereira B, Bergouignan A, Thivel D, Duclos M. Effects of cycling workstation to get tertiary employee moving on their overall health: study protocol for a REMOVE trial. Trials. 2021 May 22;22(1):359. doi: 10.1186/s13063-021-05317-2.