NCT04832516

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

27 days

First QC Date

March 31, 2021

Last Update Submit

March 31, 2022

Conditions

Keywords

sportparallelphysiopathologyphysical activity prescription

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 (1)

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

    At 6 months

Other Outcomes (3)

  • 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

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

Traditional exercise group (CLA)

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

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Motor Activity

Interventions

World Health Organization

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

United NationsInternational AgenciesOrganizationsHealth 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
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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

April 7, 2021

Primary Completion

May 4, 2021

Study Completion

November 15, 2021

Last Updated

April 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations