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Набор скоро начнётся NCT07140185

Impact of a Physical Activity Intervention on Sleep Quality, Mental and Physical Well-Being in Health Sciences Students

Без фазы С лечением Sleep Quality Sedentary Lifestlye Physical Activity Well-being

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: Regular Weekly Physical Activity Program, Weekend Warrior Physical Activity Program.
Кому может быть актуально
Состояния в реестре: Sleep Quality, Sedentary Lifestlye, Physical Activity, Well-being. Базовые параметры: 18 лет — 25 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
Tunisia
Следующий шаг
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Официальное название

Evaluation of a Physical Activity Intervention on Sleep Quality, Mental and Physical Well-Being in Health Sciences Students: A Randomized Controlled Trial Comparing Regular Weekly Activity With a "Weekend Warrior" Pattern

Обзор

This randomized controlled trial aims to compare the effects of a regular weekly physical activity program versus a "Weekend Warrior" activity pattern on sleep quality, physical well-being, and mental well-being in sedentary university students. Participants will be randomly assigned to one of the intervention groups or to a control group and assessed at baseline and after the intervention.

Подробное описание

Sedentary behavior is a growing concern among university students and is associated with poor sleep quality, fatigue, and lower mental well-being. Physical activity interventions can improve these outcomes, but the optimal frequency and pattern of activity remain unclear. This randomized controlled trial will evaluate and compare the effects of a regular weekly physical activity schedule with those of a "Weekend Warrior" pattern, in which the recommended amount of exercise is concentrated in two sessions per week. Sedentary university students will be randomly assigned to one of two intervention groups or to a control group for an 8-10 week period. Sleep quality (measured by actigraphy), physical well-being, and mental well-being will be assessed before and after the intervention. The findings of this study may help to inform public health recommendations for physical activity patterns among young adults.

Вмешательства

  • Поведенческое Regular Weekly Physical Activity Program
    Structured physical activity sessions three times per week, 50 minutes each, over 8 weeks. Includes aerobic exercises, supervised by trained instructors. Goal is to distribute the recommended weekly activity evenly.
  • Поведенческое Weekend Warrior Physical Activity Program
    Same total weekly activity as Arm 1, but concentrated in 2 weekend sessions of 75 minutes each. Includes aerobic exercises, supervised by the same trained instructors.

Первичные конечные точки

  • Sleep Efficiency (Actigraphy) [Срок оценки: Baseline (Week 0) and Post-intervention (Week 8)]
  • Subjective Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) [Срок оценки: Baseline (Week 0) and End of Intervention (Week 8)]
Вторичные конечные точки (4)
  • Psychological Well-Being (WHO-5 Well-Being Index) [Срок оценки: Baseline (Week 0) and End of Intervention (Week 8)]
  • Mental Health (Depression, Anxiety and Stress Scale, DASS-21) [Срок оценки: Baseline (Week 0) and End of Intervention (Week 8)]
  • Perceived Fatigue (Fatigue Severity Scale, FSS) [Срок оценки: Baseline (Week 0) and End of Intervention (Week 8)]
  • Functional Endurance (6-Minute Walk Test, 6MWT) [Срок оценки: Baseline (Week 0) and End of Intervention (Week 8)]

Критерии участия

Критерии включения

  • Aged 18 to 25 years.
  • Low level of physical activity, determined using the validated International Physical Activity Questionnaire (IPAQ) according to its scoring thresholds.
  • Provided written informed consent.
  • Available to participate in the entire intervention program and all planned assessments.

Критерии исключения

  • Current use of medications that may affect sleep quality or alertness (e.g., sedative hypnotics, sedative antidepressants, psychostimulants).
  • History of serious medical conditions or any contraindication to moderate physical activity.
  • Morbid obesity.
  • Current pregnancy during the study period.
  • Participation in another intervention program simultaneously.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Tunisia · 1 центр
  • Private Faculty of Health Sciences Sfax, Tunisia — Sfax

Идентификаторы

NCT: NCT07140185 · FMS110590-80-25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗