Clinical trial NCT06822075: Impact of a Physical Activity Program on the Mental Health of Medical Students.
Official title: SANTE - Solidarité, Activités Sportives et Ludiques, Nouveauté, Tissu et Étudiants
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Health Behavior
Health Related Physical Fitness
Mental Health
Sedentary Behaviors
Physical Inactivity
Medical Student
Keywords: Health
Student
Curriculum
Behavior
Medical
Physical activity
Sedentary
Mental and physical health
Isolation
Loneliness
Lead sponsor: Research on Healthcare Performance Lab U1290
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: An interventional study (intervention = SANTE program) with a crossover protocol, preceded by an randomization (1:1). One group will get SANTE Program during the first period of the study, then noting during the second period.

The other group will get noting during the first period of the study, then SANTE program during the second period. Both groups will successively benefit from the intervention (INT-1 group first, followed by the INT-2 group).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: University students frequently adopt a sedentary lifestyle with low levels of physical activity, leading to a deterioration in their health. A significant number of them also suffer from social isolation. Moreover, numerous studies have highlighted the vulnerability of university students (particularly those in medical programs) to mental health issues. Medical students, with their demanding academic curriculum, are no exception to this trend.

A student association at the Lyon Est Faculty of Medicine reported that students' mental health is very low (2022): at least 1 in 2 students has experienced a depressive episode, and 1 in 3 has had suicidal thoughts during their studies. Other recent studies indicate that medical students at Lyon Est exhibit high levels of stress, low self-confidence, and excessive sedentary behavior (ECOSTRESS and ECOSPERF studies, 2021, 2022, and 2023). Unfortunately, in 2024, new mental health surveys among medical students from the second year through the end of their internship continue to confirm these findings.

The SANTE project aims to offer solution to student to a highly effective means of improving both their mental health and their level of physical activity throught an intervention program. More precisely, the goal of this interventional study is to evaluate the impact of a physical activity program on the mental health in second-cycle medical students at the University of Lyon 1. The development of the SANTÉ program was based on (i) data from the literature, (ii) results from a previous local study (IRB No. 2024-07-02-03) that identified student needs through individual interviews and focus groups, and (iii) local findings from a co-construction workshop with students.


Eligibility criteria: Inclusion Criteria:

* Being a 2th-year or a 3th-year medical student at the Faculty of Medicine Lyon East and Lyon South during the academic years 2024-2025.
* Having read the information note.
* Having signed the written consent.

Exclusion Criteria:

* No exclusion criteria will be applied.

Primary outcomes:
measure: Overall mental health : Evolution of the score obtained at the Depression Anxiety and Stress Scale-21 (DASS-21)
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Secondary outcomes:
measure: Perceived level of physical activity : Score obtained at the Onaps-PAQ on physical activity levels.
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Perceived level of well-being : Score obtained at The World Health Organization-Five (WHO-5) Well-Being Index
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Perceived level of stress : Score obtained at the Perceveid Stress Scale (PSS)
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Perceived level of loneliness : Score obtained at the UCLA Loneliness Scale.
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Perceived level of sleep disturbance : Score obtained at the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Perceived level of fatigue : Score obtained at the Multidimentional Fatigue Inventory (MFI)
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Habits and beliefs about physical activity : Scores obtained at the Habits and Beliefs About Physical Activity Questionnaire
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Physical Fitness markers - Strength. The force developed during a maximal isometric contraction of the quadriceps.
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Physical Fitness markers markers - Power. Height of jump.
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Physical Fitness markers markers - Power. Height of jump.
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Physical Fitness markers - Endurance. Speed through the endurance test.
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Physical Fitness markers - Endurance. Heart rate during the endurance test.
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Physical Fitness markers - Flexibility. Lower body
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
measure: Physical Fitness markers - Flexibility. Upper body
timeFrame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Other outcomes:
measure: Likert - Questionnaire of satisfaction
timeFrame: Week 15-16 (Post-intervention)
Locations:
city: Lyon
country: France
facility: RESHAPE
Study officials:
affiliation: RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.
name: Sophie Schlatter, Dr.
role: PRINCIPAL_INVESTIGATOR
References: