Preventing Burnout Among Caregivers Through Physical Activity

NCT06815484 | Recruiting

• 1 other identifier: 2024-A02575-42
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Burn Out

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Study Arms (2)

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.

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.

Other: Recommendations of the World Health Organisation

Interventions

Intervention group with physical activity programme OTHER

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.

Intervention group : adaptive physical activity programme

Recommendations of the World Health Organisation OTHER

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; Intervention group : adaptive physical activity programme

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Thomas LANZ, MD

CONTACT

472172626; lanzthomas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The choice of randomisation by minimisation allows participants to be allocated at random to the two groups (intervention and control groups), thus ensuring a balance in the known characteristics likely to influence the results.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, prospective, comparative, randomised (2 arms), controlled study

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (1)