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

Healthy Volunteers Clinical Trial

— SELFIT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04832516
• Other study ID #: 20CH150
• Secondary ID: 2020-A03052-37
• Status: Terminated
• Phase: N/A
• Start date: April 7, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• 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.

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: Terminated
• Enrollment: 32
• Est. completion date: November 15, 2021
• Est. primary completion date: May 4, 2021
• 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

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

Related Conditions & MeSH terms

• Exercise
• Health
• Healthy Volunteers
• Quality of Life

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
Other	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
Other	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
Other	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
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