Study Stopped
sponsor decision
Effect of Individualized Training Versus Non-individualized Training to Improve Quality of Life of Sedentary Employees
SELFIT
2 other identifiers
interventional
32
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedStudy Start
First participant enrolled
April 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2021
CompletedApril 8, 2022
March 1, 2022
27 days
March 31, 2021
March 31, 2022
Conditions
Keywords
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)
EXPERIMENTALGroup 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.
Traditional exercise group (CLA)
ACTIVE COMPARATORGroup with traditional exercise (CLA). The CLA group will perform exercises following WHO (World Health Organization) prescription.
Interventions
The CLA group will perform exercises following WHO (World Health Organization) prescription
The IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CLEMENT FOSCHIA, MD
CHU St-Etienne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- 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