NCT04153214

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

12 months

First QC Date

November 4, 2019

Last Update Submit

January 21, 2020

Conditions

Sedentary Behavior

Keywords

Cardiometabolic healthSedentary BehaviorActive workstationCycling desk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (36)

  • Body composition

    day 90

  • Body composition

    day 180

  • Body composition

    day 1

  • Biological parameters - insulin

    Day 1

  • Biological parameters - insulin

    Day 90

  • +31 more secondary outcomes

Study Arms (2)

Cycling workstation

EXPERIMENTAL

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

control

PLACEBO COMPARATOR

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

Interventions

cyclingBEHAVIORAL

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

Cycling workstationcontrol

Eligibility Criteria

Age18 Years - 61 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 known neuromuscular pathology: myopathy, myasthenia, rhabdomyolysis, paraplegia, hemiplegia
  • Subject treated by beta-blocker
  • Subject diagnosed and/or treated for schizophrenia, bipolar disorders, major depression
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 38616275DERIVED

  • 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.

    PMID: 35673701DERIVED

  • 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.

    PMID: 34022938DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Martine Duclos

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

04 73 75 11 95drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

January 6, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

FR(1)