Healthy Volunteers Clinical Trial
— MOVING_LABOfficial 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
Verified date | July 2022 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Saint-Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
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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