Preventing Burnout Among Caregivers Through Physical Activity (PACA)

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).

Study Overview

• Status: Completed
• Conditions: Burn Out
• Intervention / Treatment: Other: Intervention group with physical activity programme; Other: Recommendations of the World Health Organisation

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69009
    • Clinique de la Sauvegarde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group : adaptive physical activity programme; 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; 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.; Other: Recommendations of the World Health Organisation; 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.
Active Comparator: Control Group : recommendations on physical activity; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Actual): April 2, 2026
• Study Completion (Actual): April 2, 2026

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Burnout, Psychological
• Other Study ID Numbers: 2024-A02575-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No