ExerciseSELFITNCT04832516
Effect of Individualized Training Versus Non-individualized Training to Improve Quality of Life of Sedentary Employees
A study testing Performing following WHO (World Health Organization) and Performing on their needs in people with Exercise and Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Healthy Volunteers, Health
- What is being tested?
- Performing following WHO (World Health Organization) and Performing on their needs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2021to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary people
- Affiliate to health care organism
- Subject who gave their consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise, Healthy Volunteers, Health, Quality of Life
- Being tested
- Performing following WHO (World Health Organization), Performing on their needs
- Keywords
- sport, parallel, physiopathology, physical activity prescription
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing following WHO (World Health Organization)Other
The CLA group will perform exercises following WHO (World Health Organization) prescription
Performing on their needsOther
The IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Performing following WHO (World Health Organization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 months
Secondary outcomes (1)
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.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start7 Apr 2021
- Primary completion4 May 2021
- Study completion15 Nov 2021
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CLEMENT FOSCHIA, MD, Principal investigator, CHU St-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832516
- Sponsor's protocol ID
- 20CH150
- Other IDs
- 2020-A03052-37
- Acronym
- SELFIT
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individualized Training Versus Non-individualized Training to Improve Quality of Life of Sedentary Employees: Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT04832516
- Acronym / sponsor ID
- SELFIT / 20CH150
- Conditions
- Exercise, Healthy Volunteers, Health, Quality of Life
- Keywords
- sport, parallel, physiopathology, physical activity prescription
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individualized exercise group (IND) | Experimental | Other: Performing on their needsGroup 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 comparator | Other: Performing following WHO (World Health Organization)Group with traditional exercise (CLA). The CLA group will perform exercises following WHO (World Health Organization) prescription. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sedentary people
- Affiliate to health care organism
- Subject who gave their consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performing following WHO (World Health Organization)The CLA group will perform exercises following WHO (World Health Organization) prescription | Other | Traditional exercise group (CLA) |
| Performing on their needsThe IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment. | Other | Individualized exercise group (IND) |
Primary outcome
SF-12 Score
Time frame: At 6 months
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
1 secondary outcome
Maximum oxygen consumption (VO2max in ml/kg/min)
Time frame: At 6 months
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CLEMENT FOSCHIA, MD principal investigator
CHU St-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performing following WHO (World Health Organization) and Performing on their needs in people with Exercise and Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-12 Score (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.