Burn OutPACANCT06815484
Preventing Burnout Among Caregivers Through Physical Activity
A study testing Intervention group with physical activity programme and Recommendations of the World Health Organisation in people with Burn Out, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of this study is to evaluate the impact of an adaptive physical activity programme to prevent the risk of burnout at the end of the programme (10 weeks after the start of the intervention). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn Out
- What is being tested?
- Intervention group with physical activity programme and Recommendations of the World Health Organisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2025to 2 Apr 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years ;
- Non-physician health professionals at the Clinique de la Sauvegarde ;
- Low or moderate level of physical activity, as assessed by the questionnaire International Physical Activity Questionnaire. In fact, work-related physical activity is not associated with a reduction in burnout ;
- Absence of serious chronic pathology incompatible with the physical activity of the protocol ;
- Willing and available to commit to the project for the duration of the study ;
- Using a personal smartphone or tablet and with an Internet connection ;
- Able to read, write and understand French ;
- Membership of a social security scheme.
Who cannot join
- High level of physical activity (not including work-related physical activity) ;
- Contraindication to physical activity (uncontrolled hypertension, uncontrolled heart disease...) ;
- Concurrent participation in another physical activity study ;
- Pregnant or likely to be pregnant ;
- Unable to be monitored for medical, social, family, geographical or psychological reasons for the duration of the study ;
- Persons deprived of their liberty by judicial or adm inistrative decision, or adults protected by law.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-centre, Randomised, Controlled Study Designed to Evaluate the Impact of a Nine-week Supervised Physical Activity Programme Physical Activity Programme on Reducing the Risk of Burnout in Burnout in Carers
The purpose of this study is to evaluate the impact of an adaptive physical activity programme to prevent the risk of burnout at the end of the programme (10 weeks after the start of the intervention).
Read the detailed description
The PACA trial is a pilot, prospective, comparative, randomised (2 arms), controlled, single-centre study.
The study population consisted of adult healthcare professionals at the Clinique de la Sauvegarde with a low to moderate level of physical activity and no contraindications to physical activity.
Participants will be randomised into two arms (ratio 1:1):
- Arm A (intervention): Participants will benefit from an adaptive physical activity programme supervised by a physical activity professional over a 9-week period.
- Arm B (control): Participants will receive the recommendations of the world health organisation for physical activity.
- Conditions
- Burn Out
- Being tested
- Intervention group with physical activity programme, Recommendations of the World Health Organisation
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group with physical activity programmeOther
Programme comprising active breaks to be incorporated into daily life, supervised group physical activity sessions with personalised advice and a motivational interview with a physical activity professional to encourage regular physical activity.
Recommendations of the World Health OrganisationOther
The World Health Organisation's recommendations on physical activity, which recommend at least 150 minutes a week of moderate-intensity activity or 75 minutes of high-intensity activity, and highlight the importance of limiting sedentary behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group : adaptive physical activity programme | Experimental | Participants will benefit from an adaptive physical activity programme supervised by a physical activity professional over a 9-week period. Participants will also receive the World Health Organisation's recommendations on physical activity, which recommend at least 150 minutes a week of moderate-intensity activity or 75 minutes of high-intensity activity, and highlight the importance of limiting sedentary behaviour. Receives: Other: Intervention group with physical activity programme; Other: Recommendations of the World Health Organisation |
| Control Group : recommendations on physical activity | Active comparator | Participants will be given only the World Health Organisation's recommendations on physical activity. At the end of the 9-week intervention period, participants will have the opportunity to take part in a motivational interview with a physical activity professional to encourage regular physical activity. Receives: Other: Recommendations of the World Health Organisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shirom - Melamed Burnout Measure
The primary endpoint is the burnout will be measured by the score on the Shirom - Melamed Burnout Measure questionnaire.
The validated French version of the Shirom-Melamed Burnout Measure comprises 14 items assessed on a Likert scale from 1 (never) to 7 (always), quantifying the frequency of symptoms experienced over the last seven days.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start12 Mar 2025
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn OutStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, prospective, comparative, randomised (2 arms), controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815484
- Sponsor's protocol ID
- 2024-A02575-42
- Acronym
- PACA
- Status last verified
- May 2026
- First submitted
- 3 Feb 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre, Randomised, Controlled Study Designed to Evaluate the Impact of a Nine-week Supervised Physical Activity Programme Physical Activity Programme on Reducing the Risk of Burnout in Burnout in Carers
- ClinicalTrials.gov ID
- NCT06815484
- Acronym / sponsor ID
- PACA / 2024-A02575-42
- Conditions
- Burn Out
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 7 Feb 2025 (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 purpose of this study is to evaluate the impact of an adaptive physical activity programme to prevent the risk of burnout at the end of the programme (10 weeks after the start of the intervention).
Detailed description
The PACA trial is a pilot, prospective, comparative, randomised (2 arms), controlled, single-centre study.
The study population consisted of adult healthcare professionals at the Clinique de la Sauvegarde with a low to moderate level of physical activity and no contraindications to physical activity.
Participants will be randomised into two arms (ratio 1:1):
- Arm A (intervention): Participants will benefit from an adaptive physical activity programme supervised by a physical activity professional over a 9-week period.
- Arm B (control): Participants will receive the recommendations of the world health organisation for physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Pilot, prospective, comparative, randomised (2 arms), controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention group : adaptive physical activity programme | Experimental | Other: Intervention group with physical activity programme, Other: Recommendations of the World Health OrganisationParticipants will benefit from an adaptive physical activity programme supervised by a physical activity professional over a 9-week period. Participants will also receive the World Health Organisation's recommendations on physical activity, which recommend at least 150 minutes a week of moderate-intensity activity or 75 minutes of high-intensity activity, and highlight the importance of limiting sedentary behaviour. |
| Control Group : recommendations on physical activity | Active comparator | Other: Recommendations of the World Health OrganisationParticipants will be given only the World Health Organisation's recommendations on physical activity. At the end of the 9-week intervention period, participants will have the opportunity to take part in a motivational interview with a physical activity professional to encourage regular physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years ;
- Non-physician health professionals at the Clinique de la Sauvegarde ;
- Low or moderate level of physical activity, as assessed by the questionnaire International Physical Activity Questionnaire. In fact, work-related physical activity is not associated with a reduction in burnout ;
- Absence of serious chronic pathology incompatible with the physical activity of the protocol ;
- Willing and available to commit to the project for the duration of the study ;
Key exclusion criteria (6 listed)
- High level of physical activity (not including work-related physical activity) ;
- Contraindication to physical activity (uncontrolled hypertension, uncontrolled heart disease...) ;
- Concurrent participation in another physical activity study ;
- Pregnant or likely to be pregnant ;
- Unable to be monitored for medical, social, family, geographical or psychological reasons for the duration of the study ;
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 |
|---|---|---|
| Intervention group with physical activity programmeProgramme comprising active breaks to be incorporated into daily life, supervised group physical activity sessions with personalised advice and a motivational interview with a physical activity professional to encourage regular physical activity. | Other | Intervention group : adaptive physical activity programme |
| Recommendations of the World Health OrganisationThe World Health Organisation's recommendations on physical activity, which recommend at least 150 minutes a week of moderate-intensity activity or 75 minutes of high-intensity activity, and highlight the importance of limiting sedentary behaviour. | Other | Control Group : recommendations on physical activity, Intervention group : adaptive physical activity programme |
Primary outcome
Shirom - Melamed Burnout Measure
Time frame: 10 weeks
The primary endpoint is the burnout will be measured by the score on the Shirom - Melamed Burnout Measure questionnaire. The validated French version of the Shirom-Melamed Burnout Measure comprises 14 items assessed on a Likert scale from 1 (never) to 7 (always), quantifying the frequency of symptoms experienced over the last seven days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group with physical activity programme and Recommendations of the World Health Organisation in people with Burn Out, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 7 May 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Shirom - Melamed Burnout Measure (time frame: 10 weeks). 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 7 May 2026.