Evaluation of Physical Capacities Within the Company and Effect of a Personalized Versus Traditional Training Program on the Quality of Life of Sedentary Employees

NCT04998266 | Completed

• 2 other identifiers: 21CH1162021-A01511-40
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Health

Keywords

sport; parallel; physiopathology; physical activity prescription; quality of life; exercise; Company

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Maximum oxygen consumption (VO2max in ml/kg/min)

  At 6 months

• Power of the lower limbs of employees in watt (W)

  At 6 months

• Grip force in Newton (N)

  At 6 months

• Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)

  At 6 months

Study Arms (2)

Individualized exercise group (IND)

EXPERIMENTAL

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

Traditional exercise group (CLA)

ACTIVE COMPARATOR

Group with traditional exercise (CLA). The CLA group will perform exercises following WHO (World Health Organization) prescription.

Other: Performing following WHO (World Health Organization)

Interventions

Performing following WHO (World Health Organization) OTHER

The CLA group will perform exercises following WHO (World Health Organization) prescription

Traditional exercise group (CLA)

Performing on their needs OTHER

The IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment.

Individualized exercise group (IND)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• People with degenerative disease
• Cardiovascular trouble
• Subject who are not able to understand the proceeding of the study or to give their consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

Related Publications (1)

• Le Mat Y, Casali C, Le Mat F, Feasson L, Foschia C, Gery M, Rossi J, Millet GY. Impact of a Self-Autonomous Evaluation Station and Personalized Training Algorithm on Quality of Life and Physical Capacities in Sedentary Adults: Randomized Controlled Trial. JMIR Form Res. 2024 Oct 4;8:e45461. doi: 10.2196/45461.

  PMID: 39365990 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

World Health Organization

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

United Nations; International Agencies; Organizations; Health Care Economics and Organizations

Study Officials

• CLEMENT FOSCHIA, MD

  CHU St-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After first session evaluation, employees will be randomly assigned to one of the 2 followings groups: (1) group with traditional exercise (CLA) and group with adapted and personalized exercises (IND). The CLA group will perform exercises following World Health Organization (WHO) prescription while the IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment. Note that all session evaluations are investigated within the company of the participant

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 10, 2021
• Study Start: October 5, 2021
• Primary Completion: March 9, 2022
• Study Completion: July 21, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)