MOVING_LAB: Evaluation of Physical Capacities Within the Company and Effect of a Personalized Versus Traditional Training Program on the Quality of Life of Sedentary Employees

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Recruiting
CT.gov ID
NCT04998266
Collaborator
(none)
116
Enrollment
1
Location
2
Arms
16.8
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. Several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. However, it seems important to individualize these recommendations in order to prescribe the best possible dose of physical activity for each individual. In this project, the investigators want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life.

The originality of this project is to evaluate physical capacities directly within the company of the participants instead of hospital unit.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Performing following WHO (World Health Organization)
  • Other: Performing on their needs
N/A

Detailed Description

Physical activity (PA) is one of the major determinants of health. Indeed, the practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. The effects are beneficial regardless of age, gender and state of health. Moreover, in addition to the well-being of employees, several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. Today, the World Health Organization (WHO) prescribes 150 min of physical activity per week regardless of the person's profile (active employee, employee working in his office, construction worker, etc.).. In this project,the investigators therefore want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
After first session evaluation, employees will be randomly assigned to one of the 2 followings groups: (1) group with traditional exercise (CLA) and group with adapted and personalized exercises (IND). The CLA group will perform exercises following World Health Organization (WHO) prescription while the IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment. Note that all session evaluations are investigated within the company of the participantAfter first session evaluation, employees will be randomly assigned to one of the 2 followings groups: (1) group with traditional exercise (CLA) and group with adapted and personalized exercises (IND). The CLA group will perform exercises following World Health Organization (WHO) prescription while the IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment. Note that all session evaluations are investigated within the company of the participant
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of Physical Capacities Within the Company and Effect of a Personalized Versus Traditional Training Program on the Quality of Life of Sedentary Employees: Randomized Controlled Trial
Actual Study Start Date :
Oct 5, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Individualized exercise group (IND)

Group with adapted and personalized exercises (IND).The IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment.

Other: Performing on their needs
The IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment.

Active Comparator: Traditional exercise group (CLA)

Group with traditional exercise (CLA). The CLA group will perform exercises following WHO (World Health Organization) prescription.

Other: Performing following WHO (World Health Organization)
The CLA group will perform exercises following WHO (World Health Organization) prescription

Outcome Measures

Primary Outcome Measures

  1. SF-12 Score [At 6 months]

    The primary outcome is a change in Short Form 12 (SF-12) score from baseline to 6 months of exercise intervention for the 2 groups (IND and CLA). Physical component scored between 0-72 Mental component scored between 0-70 For each component 0 mean a worse outcome

Secondary Outcome Measures

  1. Maximum oxygen consumption (VO2max in ml/kg/min) [At 6 months]

    Maximum oxygen consumption (VO2max in ml/kg/min) during a sub-maximum exercise on an ergometric bike from baseline to 6 months of exercise intervention for both groups.

  2. Power of the lower limbs of employees in watt (W) [At 6 months]

    Measurement of the power (in W) developed during the realization of 2 sprints of a duration of 8 seconds interspersed by 2 minutes of recovery on the same ergonomic bicycle from baseline to 6 months of exercise intervention for both groups

  3. Grip force in Newton (N) [At 6 months]

    Grip force evaluated in Newton (N) by the dynamometer (or handgrip) from baseline to 6 months of exercise intervention for both groups.

  4. Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) [At 6 months]

    The perceived fatigue of employees will be assessed (from baseline to 6 months of exercise intervention for both groups) using the FACIT-F scale Scored between 0 and 52 A score below 34 means that the subject experiences significant fatigue in daily life, potentially impacting his quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria

  • Sedentary people

  • Affiliate to health care organism

  • Subject who gave their consent

  • Employee of a company having accepted the terms of the study, as well as the agreement of the occupational physician

Exclusion Criteria:
  • People with degenerative disease

  • Cardiovascular trouble

  • Subject who are not able to understand the proceeding of the study or to give their consent

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CHU Saint-EtienneSaint-ÉtienneFrance

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: CLEMENT FOSCHIA, MD, CHU St-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT04998266
Other Study ID Numbers:
  • 21CH116
  • 2021-A01511-40
First Posted:
Aug 10, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Study Results

No Results Posted as of Nov 17, 2021