NCT04864028

Brief Summary

The recent literature has highlighting the importance of the time of SB 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 (standing, walking, cycling, stepping) because they reduce sedentary time at work and increase physical activity with positive effects on the global health. However inter variability in energy response have been identified during a sit to stand allocation with subject "savers" profile showing an increase in energy expenditure while others categorized as "non-savers" increased significantly their energy expenditure between sitting and standing position. As others active workstation strategies exist, this study aim to first, better characterize energy response to posture and activity allocation (15min sit-15min stand-15min sit-15min low intensity cycling), secondly to identify parameters that could explain different energy profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

April 9, 2021

Last Update Submit

July 7, 2023

Conditions

Keywords

Active workstationcyclingenergy expendituresedentary

Outcome Measures

Primary Outcomes (1)

  • energy expenditure

    Using an indirect calorimetry device change in energy expenditure will be assed during the 1h posture /activity allocation (15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling)

    change from baseline to the experimental visit (Day 1)

Secondary Outcomes (8)

  • physical activity level (ActiGraph)

    during the 7 days following the experimental session

  • physical activity level (ActivPAL)

    during the 7 days following the experimental session

  • Body composition : fat mass and fat free mass

    day 0

  • upper limb strength

    during the experimental session after energy expenditure assessment (Day 1)

  • aerobic fitness

    during the experimental session after energy expenditure assessment (day 1)

  • +3 more secondary outcomes

Study Arms (1)

Healthy volunteer

EXPERIMENTAL
Other: physical activity

Interventions

15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling

Healthy volunteer

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
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 ≤ 25 kg/m2
  • Able to provide informed consent to research participation
  • Registered in the French social security system

You may not qualify if:

  • Subject using a sit-to-stand office desk or a swiss ball
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martine Duclos

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 28, 2021

Study Start

May 25, 2021

Primary Completion

December 12, 2022

Study Completion

June 29, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations