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

NCT ID: NCT04153214

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Sedentary Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cycling workstation

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

Group Type EXPERIMENTAL

cycling

Intervention Type BEHAVIORAL

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

control

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.

Group Type PLACEBO_COMPARATOR

cycling

Intervention Type BEHAVIORAL

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

Interventions

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cycling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire AME2P - Unversité Clermont Auvergne

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine Duclos

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise LACLAUTRE

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Martine Duclos

Role: primary

0473751664

References

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Nasir H, Dutheil F, Ramos I, Guirado T, de Saint-Vincent S, Thivel D, Metz L, Duclos M. Effects of portable pedal machines at work on lipoprotein subfraction profile in sedentary workers - the REMOVE study. Lipids Health Dis. 2024 Apr 14;23(1):105. doi: 10.1186/s12944-024-02098-w.

Reference Type DERIVED
PMID: 38616275 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35673701 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34022938 (View on PubMed)

Other Identifiers

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2019-A04449-48

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2019 DUCLOS 2

Identifier Type: -

Identifier Source: org_study_id

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