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Набор скоро начнётся NCT07234812

Resistance Exercise and Sleep Quality by Chronotype

Без фазы С лечением Physical Therapy Resistance Exercise Sleep Disturbances Sleep Quality

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: Moderate-Intensity Resistance Exercise Program.
Кому может быть актуально
Состояния в реестре: Physical Therapy, Resistance Exercise, Sleep Disturbances, Sleep Quality. Базовые параметры: 18 лет — 35 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effects of Tailored Resistance Exercise on Sleep Quality in Relation to Chronotype

Обзор

This study examines whether doing moderate resistance exercises in the morning can improve sleep quality and well-being in young adults. Participants with different daily activity patterns (morning or evening types) will take part in an 8-week online exercise program. The study will compare how exercise affects sleep, mood, and daily rhythm across these groups.

Подробное описание

Disturbed sleep is a widespread issue that affects health, mood, and daily function. Chronotype-the natural tendency to be active earlier or later in the day-may influence how people respond to exercise as a tool for improving sleep.

This trial investigates the effects of an 8-week, moderate-intensity resistance exercise program performed in the morning, delivered through telerehabilitation.

Participants include healthy young adults with self-identified morning or evening chronotypes. The study will measure changes in sleep quality, psychological well-being, alignment of daily rhythms, and will explore whether men and women respond differently to the program..

By comparing outcomes between chronotypes, this research aims to clarify whether exercise benefits are shaped by biological preference for morning or evening activity, or whether improvements occur regardless of chronotype.

The central question is whether improvements occur equally across chronotypes, or if biological preference shapes the response to exercise.

Null Hypothesis (H0): Moderate-intensity morning resistance exercise will have no differential effect on sleep quality, mood, or circadian alignment between participants with morning and evening chronotypes.

Alternative Hypothesis (H1):Moderate-intensity morning resistance exercise will have a differential effect on sleep quality, mood, or circadian alignment between participants with morning and evening chronotypes.

Вмешательства

  • Поведенческое Moderate-Intensity Resistance Exercise Program
    An 8-week, moderate-intensity resistance exercise program performed in the morning, 3 sessions/week on nonconsecutive days. Each 45-min session includes: 5-min warm-up (jumping jacks, high knees, running in place, hip hinge with reach, standing twists); 35-min progressive resistance training (Chest Press (Modified Push-Ups), Leg Press (Wall Sits with Squats), Squats, Shoulder Press (Resistance Band Overhead Press), Lat Pulldown (Resistance Band Pull-Downs), Rowing (Resistance Band Rows), Lower B

Первичные конечные точки

  • Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, Week 4, and Week 8; primary comparison is change from baseline to Week 8]
Вторичные конечные точки (7)
  • Change in Circadian Alignment Assessed by Munich Chronotype Questionnaire (MCTQ) [Срок оценки: Baseline and Week 8]
  • Change in Mood Assessed by Brunel Mood Scale (BRUMS) [Срок оценки: Baseline, Week 4, and Week 8]
  • Perceived Effort Assessed by OMNI Perceived Exertion Scale for Resistance Exercise (OMNI-RES) [Срок оценки: Throughout Weeks 1-8]
  • Muscle Soreness Assessed by 7-Point Likert Scale [Срок оценки: After each exercise session, Weeks 1-8]
  • Change in Physical Activity Level Assessed by International Physical Activity Questionnaire-Short Form (IPAQ-SF) [Срок оценки: Baseline and Week 8]
  • Change in Mood Assessed by Depression Anxiety Stress Scales-21 (DASS-21) [Срок оценки: Baseline, Week 4, and Week 8]
  • Change in Muscle Strength Assessed by One-Repetition Maximum (1RM) [Срок оценки: Baseline, Week 4, and Week 8]

Критерии участия

Критерии включения

  • Age between 18 and 35 years
  • Generally healthy, with mild to moderate sleep disturbance as categorized by the Pittsburgh Sleep Quality Index (PSQI)
  • Body Mass Index (BMI) < 35 kg/m²
  • No physical or organic limitations or diseases that would prevent participation in physical activity
  • Non-smoker and non-alcoholic
  • Caffeine consumption ≤ 2 cups per day (including coffee and energy drinks)
  • Have not participated in more than 60 minutes/week of usual moderate-to-vigorous physical activity in the past 6 months, categorized as "moderate" on the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
  • No clinically diagnosed sleep apnea or other medical/psychiatric disorders responsible for sleep complaints
  • Regular sleep schedule (no night shifts or transmeridian travel) in the 30 days prior to study enrollment
  • Able to speak and write English

Критерии исключения

  • Current use of medications or psychotherapeutic drugs for insomnia or other psychiatric disorders
  • Use of melatonin or other sleep aids in the past month
  • Currently performing any aerobic or mind-body exercise classes (e.g., yoga, Pilates)
  • Habitual daytime napping
  • History of epilepsy or other convulsive disorders
  • Pregnant individuals
  • Habitual or recent use (within the past 30 days) of illegal drugs, psychotropic drugs, hypnotics, stimulants, or analgesics

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
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Turkey (Türkiye) · 1 центр
  • Medipol University — Istanbul

Публикации

  • Cheville AL, Kollasch J, Vandenberg J, Shen T, Grothey A, Gamble G, Basford JR. A home-based exercise program to improve function, fatigue, and sleep quality in patients with Stage IV lung and colorectal cancer: a randomized controlled trial. J Pain Symptom Manage. 2013 May;45(5):811-21. doi: 10.1016/j.jpainsymman.2012.05.006. Epub 2012 Sep 24. PMID 23017624
  • Karandikar-Agashe G, Agrawal R. Comparative Study of the Effect of Resistance Exercises versus Aerobic Exercises in Postmenopausal Women Suffering from Insomnia. J Midlife Health. 2020 Jan-Mar;11(1):2-5. doi: 10.4103/jmh.JMH_35_19. Epub 2020 May 4. PMID 32684719
  • Passos GS, Poyares D, Santana MG, Garbuio SA, Tufik S, Mello MT. Effect of acute physical exercise on patients with chronic primary insomnia. J Clin Sleep Med. 2010 Jun 15;6(3):270-5. PMID 20572421
  • de Sa Souza H, de Melo CM, Piovezan RD, Miranda REEPC, Carneiro-Junior MA, Silva BM, Thomatieli-Santos RV, Tufik S, Poyares D, D'Almeida V. Resistance Training Improves Sleep and Anti-Inflammatory Parameters in Sarcopenic Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Dec 6;19(23):16322. doi: 10.3390/ijerph192316322. PMID 36498393
  • Maric D, Ficarra S, Di Bartolo L, Rossi C, Asimakopoulou Z, Vantarakis A, Carbonell-Baeza A, Jimenez-Pavon D, Gomes B, Tavares P, Baxter R, Pusa S, Thaller P, Papakonstantinou S, Kirkar M, Glorioso F, Galioto M, Gentile A, Thomas E, Bianco A. Effects of resistance training on sleep quality and disorders among individuals diagnosed with cancer: A systematic review and meta-analysis of randomized co PMID 38650577
  • Vickers AJ. Time course of muscle soreness following different types of exercise. BMC Musculoskelet Disord. 2001;2:5. doi: 10.1186/1471-2474-2-5. Epub 2001 Oct 23. PMID 11701094
  • Morishita S, Tsubaki A, Takabayashi T, Fu JB. Relationship between the rating of perceived exertion scale and the load intensity of resistance training. Strength Cond J. 2018 Apr;40(2):94-109. doi: 10.1519/SSC.0000000000000373. PMID 29674945
  • Robertson RJ, Goss FL, Rutkowski J, Lenz B, Dixon C, Timmer J, Frazee K, Dube J, Andreacci J. Concurrent validation of the OMNI perceived exertion scale for resistance exercise. Med Sci Sports Exerc. 2003 Feb;35(2):333-41. doi: 10.1249/01.MSS.0000048831.15016.2A. PMID 12569225

Идентификаторы

NCT: NCT07234812 · E-10840098-202.3.02-1592

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗