Effect of Individualized Training Versus Non-individualized Training to Improve Quality of Life of Sedentary Employees (SELFIT)

Effect of Individualized Training Versus Non-individualized Training to Improve Quality of Life of Sedentary Employees: Controlled Randomized 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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Exercise; Healthy Volunteers; Health
• Intervention / Treatment: Other: Performing on their needs; Other: Performing following WHO (World Health Organization)

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Sedentary people
• Affiliate to health care organism
• Subject who gave their consent

Exclusion Criteria:

• People with degenerative disease
• Pregnant women
• 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)

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: CLEMENT FOSCHIA, MD, CHU St-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Actual): May 4, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: sport; parallel; physiopathology; physical activity prescription
• Other Study ID Numbers: 20CH150; 2020-A03052-37 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No