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

Sedentary Behavior Clinical Trial

— REMOVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04153214
• Other study ID #: RBHP 2019 DUCLOS 2
• Secondary ID: 2019-A04449-48
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: January 2022

Study information

• Verified date: January 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 04 73 75 11 95
• Email: drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Behavioral:
• cycling
Participants will have a portable pedal machine under their desk and will use it 60minutes per day

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Laboratoire AME2P - Unversité Clermont Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body composition	Body fat mass, body fat free mass will be assessed by bioimpedance analysis	day 90
Secondary	Body composition	Body fat mass, body fat free mass will be assessed by bioimpedance analysis	day 180
Secondary	Body composition	Body fat mass, body fat free mass will be assessed by bioimpedance analysis	day 1
Secondary	Biological parameters - insulin	will be assessed in the fasting state using blood sample (insulin mlUI/L)	Day 1
Secondary	Biological parameters - insulin	will be assessed in the fasting state using blood sample (insulin mlUI/L)	Day 90
Secondary	Biological parameters - insulin	will be assessed in the fasting state using blood sample (insulin mlUI/L)	Day 180
Secondary	Biological parameters - glucose	will be assessed in the fasting state using blood sample (glucose g/L)	Day 1
Secondary	Biological parameters - glucose	will be assessed in the fasting state using blood sample (glucose g/L)	Day 90
Secondary	Biological parameters - glucose	will be assessed in the fasting state using blood sample (glucose g/L)	Day 180
Secondary	Biological parameters - triglycerides	will be assessed in the fasting state using blood sample (triglycerides g/L)	Day 1
Secondary	Biological parameters - triglycerides	will be assessed in the fasting state using blood sample (triglycerides g/L)	Day 90
Secondary	Biological parameters - triglycerides	will be assessed in the fasting state using blood sample (triglycerides g/L)	Day 180
Secondary	Biological parameters - cholesterol	will be assessed in the fasting state using blood sample (cholesterol g/L)	Day 1
Secondary	Biological parameters - cholesterol	will be assessed in the fasting state using blood sample (cholesterol g/L)	Day 90
Secondary	Biological parameters - cholesterol	will be assessed in the fasting state using blood sample (cholesterol g/L)	Day 180
Secondary	Biological parameters - CRP	will be assessed in the fasting state using blood sample (CRP-us mg/L)	Day 1
Secondary	Biological parameters - CRP	will be assessed in the fasting state using blood sample (CRP-us mg/L)	Day 90
Secondary	Biological parameters - CRP	will be assessed in the fasting state using blood sample (CRP-us mg/L)	Day 180
Secondary	Biological parameters - anandamide	will be assessed in the fasting state using blood sample (plasma concentration anandamide pmol/ml)	Day 1
Secondary	Biological parameters - anandamide	will be assessed in the fasting state using blood sample (plasma concentration anandamide pmol/ml)	Day 90
Secondary	Biological parameters - anandamide	will be assessed in the fasting state using blood sample (plasma concentration anandamide pmol/ml)	Day 180
Secondary	Psychological assessment	Through an evaluation of healthy life span, stress at work and outside, stress management and anxiety (questionnaires)	Day 1
Secondary	Psychological assessment	Through an evaluation of healthy life span, stress at work and outside, stress management and anxiety (questionnaires)	Day 90
Secondary	Psychological assessment	Through an evaluation of healthy life span, stress at work and outside, stress management and anxiety (questionnaires)	Day 180
Secondary	Resting metabolic rate	will be assessed at rest during 30 minutes using indirect calorimetry	Day 1
Secondary	Resting metabolic rate	will be assessed at rest during 30 minutes using indirect calorimetry	Day 90
Secondary	Resting metabolic rate	will be assessed at rest during 30 minutes using indirect calorimetry	Day 180
Secondary	Physical capacity	will be assessed with the Step Test 6 minutes	Day 1
Secondary	Physical capacity	will be assessed with the Step Test 6 minutes	Day 90
Secondary	Physical capacity	will be assessed with the Step Test 6 minutes	Day 180
Secondary	Muscle Strength	will be assessed with handgrip for upper limb muscle and isokinetic dynamometer for lower limb muscle	Day 1
Secondary	Muscle Strength	will be assessed with handgrip for upper limb muscle and isokinetic dynamometer for lower limb muscle	Day 90
Secondary	Muscle Strength	will be assessed with handgrip for upper limb muscle and isokinetic dynamometer for lower limb muscle	Day 180
Secondary	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
Secondary	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
Secondary	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