- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04998266
Evaluation of Physical Capacities Within the Company and Effect of a Personalized Versus Traditional Training Program on the Quality of Life of Sedentary Employees (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: Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Saint-Étienne, France
- CHU Saint-Etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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.
|
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.
|
The CLA group will perform exercises following WHO (World Health Organization) prescription
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF-12 Score
Time Frame: 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 |
At 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum oxygen consumption (VO2max in ml/kg/min)
Time Frame: 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.
|
At 6 months
|
Power of the lower limbs of employees in watt (W)
Time Frame: 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
|
At 6 months
|
Grip force in Newton (N)
Time Frame: 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.
|
At 6 months
|
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)
Time Frame: 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.
|
At 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: CLEMENT FOSCHIA, MD, Chu St-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21CH116
- 2021-A01511-40 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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