Effects of Cycling Workstation on Cardiometabolic Health for Workers With an Office-sitting Desk (REMOVE)

Study Overview
=================
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.

Official Title
-----------------
Effects of Cycling Workstation on Cardiometabolic Health for Workers With an Office-sitting Desk

Conditions
-----------------
Sedentary Behavior

Intervention / Treatment
-----------------
* Behavioral: cycling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 61 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cycling workstation<br>Participants will have a portable pedal machine under their desk and will use it 60minutes per day (30minutes in the morning and 30minutes in the afternoon) during 6 months | Behavioral: cycling<br>* Participants will have a portable pedal machine under their desk and will use it 60minutes per day<br>|
| Placebo Comparator: control<br>Daily activities unchanged during 3 months. Then they will have a portable pedal machine under their desk and will use it 60minutes per day (30minutes in the morning and 30minutes in the afternoon) during 3 months. | Behavioral: cycling<br>* Participants will have a portable pedal machine under their desk and will use it 60minutes per day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Quantify by the use of an accelerometer device wears at the hip | month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Body fat mass, body fat free mass will be assessed by bioimpedance analysis | day 90 | 
| Body composition | Body fat mass, body fat free mass will be assessed by bioimpedance analysis | day 180 | 
| Body composition | Body fat mass, body fat free mass will be assessed by bioimpedance analysis | day 1 | 
| Biological parameters - insulin | will be assessed in the fasting state using blood sample (insulin mlUI/L) | Day 1 | 
| Biological parameters - insulin | will be assessed in the fasting state using blood sample (insulin mlUI/L) | Day 90 | 
| Biological parameters - insulin | will be assessed in the fasting state using blood sample (insulin mlUI/L) | Day 180 | 
| Biological parameters - glucose | will be assessed in the fasting state using blood sample (glucose g/L) | Day 1 | 
| Biological parameters - glucose | will be assessed in the fasting state using blood sample (glucose g/L) | Day 90 | 
| Biological parameters - glucose | will be assessed in the fasting state using blood sample (glucose g/L) | Day 180 | 
| Biological parameters - triglycerides | will be assessed in the fasting state using blood sample (triglycerides g/L) | Day 1 | 
| Biological parameters - triglycerides | will be assessed in the fasting state using blood sample (triglycerides g/L) | Day 90 | 
| Biological parameters - triglycerides | will be assessed in the fasting state using blood sample (triglycerides g/L) | Day 180 | 
| Biological parameters - cholesterol | will be assessed in the fasting state using blood sample (cholesterol g/L) | Day 1 | 
| Biological parameters - cholesterol | will be assessed in the fasting state using blood sample (cholesterol g/L) | Day 90 | 
| Biological parameters - cholesterol | will be assessed in the fasting state using blood sample (cholesterol g/L) | Day 180 | 
| Biological parameters - CRP | will be assessed in the fasting state using blood sample (CRP-us mg/L) | Day 1 | 
| Biological parameters - CRP | will be assessed in the fasting state using blood sample (CRP-us mg/L) | Day 90 | 
| Biological parameters - CRP | will be assessed in the fasting state using blood sample (CRP-us mg/L) | Day 180 | 
| Biological parameters - anandamide | will be assessed in the fasting state using blood sample (plasma concentration anandamide pmol/ml) | Day 1 | 
| Biological parameters - anandamide | will be assessed in the fasting state using blood sample (plasma concentration anandamide pmol/ml) | Day 90 | 
| Biological parameters - anandamide | will be assessed in the fasting state using blood sample (plasma concentration anandamide pmol/ml) | Day 180 | 
| Psychological assessment | Through an evaluation of healthy life span, stress at work and outside, stress management and anxiety (questionnaires) | Day 1 | 
| Psychological assessment | Through an evaluation of healthy life span, stress at work and outside, stress management and anxiety (questionnaires) | Day 90 | 
| Psychological assessment | Through an evaluation of healthy life span, stress at work and outside, stress management and anxiety (questionnaires) | Day 180 | 
| Resting metabolic rate | will be assessed at rest during 30 minutes using indirect calorimetry | Day 1 | 
| Resting metabolic rate | will be assessed at rest during 30 minutes using indirect calorimetry | Day 90 | 
| Resting metabolic rate | will be assessed at rest during 30 minutes using indirect calorimetry | Day 180 | 
| Physical capacity | will be assessed with the Step Test 6 minutes | Day 1 | 
| Physical capacity | will be assessed with the Step Test 6 minutes | Day 90 | 
| Physical capacity | will be assessed with the Step Test 6 minutes | Day 180 | 
| Muscle Strength | will be assessed with handgrip for upper limb muscle and isokinetic dynamometer for lower limb muscle | Day 1 | 
| Muscle Strength | will be assessed with handgrip for upper limb muscle and isokinetic dynamometer for lower limb muscle | Day 90 | 
| Muscle Strength | will be assessed with handgrip for upper limb muscle and isokinetic dynamometer for lower limb muscle | Day 180 | 
| Quality of the time spend to physical activities and sedentary behaviour | moderate and high intensity physical activity low intensity physical activity total sedentary time number of sedentary periods of ≥30 minutes, ≤10 minutes, 10 to 30 minutes Evaluate by the use of an accelerometer device wears at the hip | Day 1 | 
| Quality of the time spend to physical activities and sedentary behaviour | moderate and high intensity physical activity low intensity physical activity total sedentary time number of sedentary periods of ≥30 minutes, ≤10 minutes, 10 to 30 minutes Evaluate by the use of an accelerometer device wears at the hip | Day 90 | 
| Quality of the time spend to physical activities and sedentary behaviour | moderate and high intensity physical activity low intensity physical activity total sedentary time number of sedentary periods of ≥30 minutes, ≤10 minutes, 10 to 30 minutes Evaluate by the use of an accelerometer device wears at the hip | Day 180 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiometabolic health, Sedentary Behavior, Active workstation, Cycling desk