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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04998266
Other study ID # 21CH116
Secondary ID 2021-A01511-40
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2021
Est. completion date July 21, 2022

Study information

Verified date July 2022
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date July 21, 2022
Est. primary completion date March 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Performing following WHO (World Health Organization)
The CLA group will perform exercises following WHO (World Health Organization) prescription
Performing on their needs
The IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment.

Locations

Country Name City State
France CHU Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary SF-12 Score 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
At 6 months
Secondary Maximum oxygen consumption (VO2max in ml/kg/min) 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. At 6 months
Secondary Power of the lower limbs of employees in watt (W) 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 At 6 months
Secondary Grip force in Newton (N) Grip force evaluated in Newton (N) by the dynamometer (or handgrip) from baseline to 6 months of exercise intervention for both groups. At 6 months
Secondary Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) 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. At 6 months
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