Exercise Interventions in Obstructive Sleep Apnea Syndrome
2026年6月3日 更新者:Melis Usul、Istanbul University - Cerrahpasa
The Effect of Exercise Snacks and Aerobic Exercise on Circadian Rhythm and Functional Capacity in Individuals With Obstructive Sleep Apnea Syndrome
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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
39
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Melis Usul, PhD student
- 电话号码:+(90)5364667235
- 邮箱:melisausul1999@gmail.com
研究联系人备份
- 姓名:Gökşen Kuran Aslan, Professor
- 电话号码:+(90)5324095246
- 邮箱:goksenkuran@yahoo.com
学习地点
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-
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Istanbul、土耳其(türkiye)
- Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye
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接触:
- Melis Usul
- 电话号码:+(90)5364667235
- 邮箱:melisausul1999@gmail.com
-
首席研究员:
- Melis USUL
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副研究员:
- Gökşen Kuran Aslan
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副研究员:
- Esen Kıyan
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副研究员:
- Zeynep Banu Güngör
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Individuals with OSAHS and a body mass index (BMI) > 35 kg/m²
- Severe chronic pulmonary disease
- Neurological or musculoskeletal disorders that prevent exercise
- Unstable cardiovascular conditions
- Unstable metabolic conditions
- Severe psychiatric disorders such as bipolar disorder or schizophrenia
- Pregnancy or breastfeeding
- Individuals working night shifts or with schedules that may cause jet lag
- Use of steroid or hormone therapy
- Use of melatonin or sleep-regulating medications within the last 3 months
- Presence of acute infection or inflammation
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Aerobic Exercise Group
Aerobic Exercise Training
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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 minutes during weeks 3-4, 30 minutes during weeks 5-6, and 35 minutes during weeks 7-8.
Participants' heart rate will be monitored during exercise sessions, and perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale.In addition, all participants will be instructed to perform resistance exercises once per week.
The exercises will target the upper extremity, lower extremity, and core muscles and will consist of three different exercises.
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实验性的:Exercise Snacks Group
Exercise Snacking
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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 interval.
Thus, each session will last approximately 12 minutes.
Exercise progression will be applied every two weeks for each exercise.
During the sessions, participants will monitor their heart rate and oxygen saturation.
An oxygen saturation level below 90% will be defined as the exercise termination criterion.
Participants will be provided with a daily logbook to record completion of exercise snacking sessions.
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无干预:Control Group (Usual Care)
Usual Care
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI) Total Score
大体时间:From baseline to the end of the intervention at 8 weeks
|
Sleep quality assessed using the Pittsburgh Sleep Quality Index.
Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
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From baseline to the end of the intervention at 8 weeks
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Epworth Sleepiness Scale (ESS) Total Score
大体时间:From baseline to the end of the intervention at 8 weeks
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Daytime sleepiness will be assessed using the Epworth Sleepiness Scal (ESS).Scores ≥10 indicate excessive daytime sleepiness.
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From baseline to the end of the intervention at 8 weeks
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Morningness-Eveningness Questionnaire (MEQ) Total Score
大体时间:From baseline to the end of the intervention at 8 weeks
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Circadian rhythm preference will be assessed using the Morningness-Eveningness Questionnaire (MEQ).The questionnaire consists of 19 items evaluating sleep-wake preferences and chronotype.Higher scores indicate morningness, whereas lower scores indicate eveningness.
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From baseline to the end of the intervention at 8 weeks
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Serum Cortisol Level
大体时间:From baseline to the end of the intervention at 8 weeks
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Fasting morning serum cortisol concentration measured by chemiluminescent immunoassay.
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From baseline to the end of the intervention at 8 weeks
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Serum Thyroid-Stimulating Hormone (TSH) Level
大体时间:From baseline to the end of the intervention at 8 weeks
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Fasting morning serum TSH concentration measured by chemiluminescent immunoassay.
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From baseline to the end of the intervention at 8 weeks
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Functional Capacity
大体时间:From baseline to the end of the intervention at 8 weeks
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Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) according to American Thoracic Society criteria.
Walking distance covered within 6 minutes will be recorded in meters.
Higher values indicate better functional capacity.
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From baseline to the end of the intervention at 8 weeks
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Total Sleep Time (Sleep Diary)
大体时间:From baseline to the end of the intervention at 8 weeks
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Total sleep time will be assessed subjectively using a sleep diary based on the Consensus Sleep Diary (CSD).
Participants will complete the diary for 7 consecutive days at baseline and at week 8.
Total sleep time will be recorded in minutes.
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From baseline to the end of the intervention at 8 weeks
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Total Sleep Time (Wearable Device)
大体时间:From baseline to the end of the intervention at 8 weeks
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Total sleep time will be objectively assessed using a Polar Unite wearable activity tracker with Sleep Plus Stages™ algorithm.
Measurements will be collected over 3 consecutive nights at baseline and at week 8.
Total sleep time will be expressed in minutes.
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From baseline to the end of the intervention at 8 weeks
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Sleep Efficiency (Wearable Device)
大体时间:From baseline to the end of the intervention at 8 weeks
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Sleep efficiency will be assessed using a Polar Unite wearable activity tracker with Sleep Plus Stages™ algorithm.
Measurements will be collected over 3 consecutive nights at baseline and at week 8. Sleep efficiency will be expressed as percentage (%).
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From baseline to the end of the intervention at 8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Insomnia Severity
大体时间:From baseline to the end of the intervention at 8 weeks
|
Insomnia severity will be assessed using the Insomnia Severity Index (ISI).
The ISI consists of 7 items scored from 0 to 4, with a total score ranging from 0 to 28.
Higher scores indicate greater insomnia severity.
Scores ≥10 indicate clinically significant insomnia.
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From baseline to the end of the intervention at 8 weeks
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Waist Circumference (cm)
大体时间:From baseline to the end of the intervention at 8 weeks
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Waist circumference measured using a non-elastic tape measure.
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From baseline to the end of the intervention at 8 weeks
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Hip Circumference (cm)
大体时间:From baseline to the end of the intervention at 8 weeks
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Hip circumference measured using a non-elastic tape measure.
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From baseline to the end of the intervention at 8 weeks
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Neck Circumference (cm)
大体时间:From baseline to the end of the intervention at 8 weeks
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Neck circumference measured using a non-elastic tape measure.
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From baseline to the end of the intervention at 8 weeks
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Muscle Mass (kg)
大体时间:From baseline to the end of the intervention at 8 weeks
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Muscle mass assessed using bioelectrical impedance analysis (BIA).
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From baseline to the end of the intervention at 8 weeks
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Body Fat Percentage (%)
大体时间:From baseline to the end of the intervention at 8 weeks
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Body fat percentage assessed using bioelectrical impedance analysis (BIA).
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From baseline to the end of the intervention at 8 weeks
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Bone Mass (kg)
大体时间:From baseline to the end of the intervention at 8 weeks
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Bone mass assessed using bioelectrical impedance analysis (BIA).
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From baseline to the end of the intervention at 8 weeks
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Body Water Percentage (%)
大体时间:From baseline to the end of the intervention at 8 weeks
|
Body water percentage assessed using bioelectrical impedance analysis (BIA).
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From baseline to the end of the intervention at 8 weeks
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Fatigue Severity
大体时间:From baseline to the end of the intervention at 8 weeks
|
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS).
The FSS consists of 9 items scored from 1 to 7. Higher scores indicate greater fatigue severity.
Mean scores ≥4 indicate clinically significant fatigue.
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From baseline to the end of the intervention at 8 weeks
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Peripheral Muscle Strength
大体时间:From baseline to the end of the intervention at 8 weeks
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Peripheral muscle strength (quadriceps, biceps brachii, and handgrip strength) will be assessed using a hand-held dynamometer and handgrip dynamometer.
Higher values indicate greater muscle strength.
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From baseline to the end of the intervention at 8 weeks
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Physical Activity Level
大体时间:From baseline to the end of the intervention at 8 weeks
|
Physical activity level will be assessed using a pedometer.
Average daily step count (steps/day) will be recorded.
Higher values indicate greater physical activity.
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From baseline to the end of the intervention at 8 weeks
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Health-related quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ)
大体时间:From baseline to the end of the intervention at 8 weeks
|
Quality of life will be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ).
The questionnaire consists of 26 items with total scores ranging from 4 to 16. Lower scores indicate greater impairment in sleep-related quality of life.
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From baseline to the end of the intervention at 8 weeks
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Patient Global Impression of Change
大体时间:At the end of the intervention (8 weeks)
|
Perceived clinical improvement will be assessed using the Patient Global Impression of Change (PGIC).
The scale ranges from 1 (very much improved) to 7 (very much worse).
Lower scores indicate greater perceived improvement.
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At the end of the intervention (8 weeks)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:MELİS USUL、Istanbul University - Cerrahpasa
- 研究主任:Gökşen Kuran Aslan, Professor、Istanbul University - Cerrahpasa
- 学习椅:Esen Kıyan, Professor、Istanbul University Faculty of Medicine
- 学习椅:Zeynep Banu Güngör, Professor、Istanbul University - Cerrahpasa
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2028年2月1日
研究注册日期
首次提交
2026年5月31日
首先提交符合 QC 标准的
2026年6月3日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月8日
上次提交的符合 QC 标准的更新
2026年6月3日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.