Набор скоро начнётся NCT07634029

Exercise Interventions in Obstructive Sleep Apnea Syndrome

Без фазы С лечением Obstructive Sleep Apnea (OSA) Exercise Snacks Physical Activity Circadian Rhythm

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: Aerobic Exercise Training, Exercise Snacking.
Кому может быть актуально: Состояния в реестре: Obstructive Sleep Apnea (OSA), Exercise Snacks, Physical Activity, Circadian Rhythm. Базовые параметры: 30 лет — 65 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 →

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Официальное название

The Effect of Exercise Snacks and Aerobic Exercise on Circadian Rhythm and Functional Capacity in Individuals With Obstructive Sleep Apnea Syndrome

Обзор

Obstructive Sleep Apnea Syndrome (OSA) is a condition characterized by repeated pauses or reductions in breathing during sleep, which can negatively affect sleep quality, daytime functioning, and physical capacity. Although regular exercise is known to have beneficial effects in OSA, the effects of different exercise approaches on circadian rhythm and functional capacity have not been sufficiently investigated.The primary aim of this study is to compare the effects of exercise snacking and aerobic exercise on circadian rhythm and functional capacity in individuals with OSA, in comparison with a control group. The secondary aim is to evaluate the effects of these exercise interventions on peripheral muscle strength, fatigue level, body composition, quality of life, and physical activity level.Participants will be randomly assigned to three groups: an aerobic exercise group, an exercise snacking group, and a control group. While the exercise groups will follow their respective intervention programs, the control group will continue their routine treatment.This study aims to answer whether exercise snacking, which consists of short bouts of exercise distributed throughout the day, may be an alternative or complementary approach to traditional aerobic exercise in individuals with OSA. In addition, this study aims to be the first randomized controlled trial evaluating the effects of exercise snacking on circadian rhythm and functional capacity in individuals with OSA.

Подробное описание

Obstructive Sleep Apnea Syndrome (OSA) is a common sleep-related breathing disorder characterized by repeated episodes of partial or complete upper airway obstruction during sleep. It is associated with intermittent hypoxia, sleep fragmentation, and increased risk of cardiovascular and metabolic comorbidities. Emerging evidence also suggests a bidirectional relationship between OSA and circadian rhythm disruption, where each condition may negatively influence the other. Therefore, improving circadian regulation may be an important therapeutic target in OSA management.Exercise is a widely accepted non-pharmacological intervention in OSA due to its potential benefits on sleep-related outcomes and overall health. However, adherence to conventional structured exercise programs may be limited due to time constraints and sustainability issues. Recently, exercise snacking-short bouts of exercise performed throughout the day-has been proposed as a time-efficient and more feasible alternative to traditional exercise approaches. This strategy may improve long-term adherence by integrating physical activity into daily routines without requiring supervised sessions.Despite its potential advantages, evidence regarding the effects of exercise snacking in individuals with OSA is currently limited. In addition, there is a lack of randomized controlled trials comparing exercise snacking with aerobic exercise while also evaluating circadian rhythm-related outcomes in this population.This study is designed as a prospective, single-blind, randomized controlled trial. A total of 39 individuals diagnosed with moderate to severe OSA will be randomly assigned to three groups: aerobic exercise group, exercise snacking group, and control group. The intervention period will last 8 weeks. The aerobic exercise group will perform supervised aerobic and resistance-based training, while the exercise snacking group will perform short, home-based exercise bouts distributed across the day. The control group will continue usual medical care and receive a single session of sleep hygiene education.The study will evaluate the effects of the interventions on circadian rhythm and functional capacity as primary outcomes, and on secondary outcomes including fatigue, muscle strength, body composition, physical activity level, insomnia severity, and quality of life. Assessments will be performed at baseline and after the 8-week intervention period.

Вмешательства

Поведенческое Aerobic Exercise Training
Participants in the aerobic exercise group will undergo an 8-week supervised aerobic exercise program on a cycle ergometer, performed twice per week. Each session will last approximately 30-45 minutes and will include a 5-minute low-intensity warm-up and a 5-minute cool-down period. Exercise intensity will be set at a moderate level according to the Karvonen method. The main exercise duration will be progressively increased throughout the intervention period: 20 minutes during weeks 1-2, 25 minu
Поведенческое Exercise Snacking
The exercises will be performed by participants at home and supervised by the researcher. Since progression of each exercise will be implemented every two weeks, participants will be scheduled to attend the clinic every two weeks, where the exercises will be demonstrated. Each session will consist of six different exercises (squat, heel raises, marching in place, jumping jacks, upright row, and chest press). Each exercise will be performed for 1 minute, followed by a 1-minute seated rest interva

Первичные конечные точки

Pittsburgh Sleep Quality Index (PSQI) Total Score [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Epworth Sleepiness Scale (ESS) Total Score [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Morningness-Eveningness Questionnaire (MEQ) Total Score [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Serum Cortisol Level [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Serum Thyroid-Stimulating Hormone (TSH) Level [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Functional Capacity [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Total Sleep Time (Sleep Diary) [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Total Sleep Time (Wearable Device) [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Sleep Efficiency (Wearable Device) [Срок оценки: From baseline to the end of the intervention at 8 weeks]

Вторичные конечные точки (12)

Insomnia Severity [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Waist Circumference (cm) [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Hip Circumference (cm) [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Neck Circumference (cm) [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Muscle Mass (kg) [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Body Fat Percentage (%) [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Bone Mass (kg) [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Body Water Percentage (%) [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Fatigue Severity [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Peripheral Muscle Strength [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Physical Activity Level [Срок оценки: From baseline to the end of the intervention at 8 weeks]
Health-related quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ) [Срок оценки: From baseline to the end of the intervention at 8 weeks]

Критерии участия

Критерии включения

Individuals diagnosed with OSAHS (AHI ≥ 15) confirmed by polysomnography, with moderate or severe disease, who have been receiving CPAP therapy for at least 3 months.
Adults aged 30-65 years.
No participation in any regular exercise program within the last 6 months.