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Набор по приглашению NCT06822075

Impact of a Physical Activity Program on the Mental Health of Medical Students.

Без фазы С лечением Health Behavior Health Related Physical Fitness Mental Health Sedentary Behaviors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SANTE program.
Кому может быть актуально
Состояния в реестре: Health Behavior, Health Related Physical Fitness, Mental Health, Sedentary Behaviors. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

SANTE - Solidarité, Activités Sportives et Ludiques, Nouveauté, Tissu et Étudiants

Обзор

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.

Вмешательства

  • Поведенческое SANTE program
    The intervention will consist of distinct period. Fisrt, 3 complete assessment periods will be realized : pre-intervention (week 1-2) ; mid-intervention (week 8-9) ; post-intervention (week 15 - 16) for evaluate the evolution of the health-related behavior, mental and physical health. Second, the SANTE program intervention will be implemented. Intervention 1 (week 3 and 7) for INT-1 group receive the SANTE program and INT-2 group do noting ; Intervention 2 (week 10-14) for INT-2 group receive th

Первичные конечные точки

  • Overall mental health : Evolution of the score obtained at the Depression Anxiety and Stress Scale-21 (DASS-21) [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
Вторичные конечные точки (12)
  • Perceived level of physical activity : Score obtained at the Onaps-PAQ on physical activity levels. [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Perceived level of well-being : Score obtained at The World Health Organization-Five (WHO-5) Well-Being Index [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Perceived level of stress : Score obtained at the Perceveid Stress Scale (PSS) [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Perceived level of loneliness : Score obtained at the UCLA Loneliness Scale. [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Perceived level of sleep disturbance : Score obtained at the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Perceived level of fatigue : Score obtained at the Multidimentional Fatigue Inventory (MFI) [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Habits and beliefs about physical activity : Scores obtained at the Habits and Beliefs About Physical Activity Questionnaire [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Physical Fitness markers - Strength. The force developed during a maximal isometric contraction of the quadriceps. [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Physical Fitness markers markers - Power. Height of jump. [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Physical Fitness markers markers - Power. Height of jump. [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Physical Fitness markers - Endurance. Speed through the endurance test. [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]
  • Physical Fitness markers - Endurance. Heart rate during the endurance test. [Срок оценки: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • No exclusion criteria will be applied.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

Франция · 1 центр
  • RESHAPE — Lyon

Идентификаторы

NCT: NCT06822075 · SANTE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗