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Exercise Interventions in Obstructive Sleep Apnea Syndrome

2026년 6월 3일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

39

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 터키 (Türkiye)
      • Istanbul, 터키 (Türkiye)
        • Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye
        • 연락하다:
        • 수석 연구원:
          • Melis USUL
        • 부수사관:
          • Gökşen Kuran Aslan
        • 부수사관:
          • Esen Kıyan
        • 부수사관:
          • Zeynep Banu Güngör

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Aerobic Exercise Group
Aerobic Exercise Training
행동: 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 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.
실험적: Exercise Snacks Group
Exercise Snacking
행동: 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 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.
간섭 없음: Control Group (Usual Care)
Usual Care

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pittsburgh Sleep Quality Index (PSQI) Total Score
기간: 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.
From baseline to the end of the intervention at 8 weeks
Epworth Sleepiness Scale (ESS) Total Score
기간: From baseline to the end of the intervention at 8 weeks
Daytime sleepiness will be assessed using the Epworth Sleepiness Scal (ESS).Scores ≥10 indicate excessive daytime sleepiness.
From baseline to the end of the intervention at 8 weeks
Morningness-Eveningness Questionnaire (MEQ) Total Score
기간: From baseline to the end of the intervention at 8 weeks
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.
From baseline to the end of the intervention at 8 weeks
Serum Cortisol Level
기간: From baseline to the end of the intervention at 8 weeks
Fasting morning serum cortisol concentration measured by chemiluminescent immunoassay.
From baseline to the end of the intervention at 8 weeks
Serum Thyroid-Stimulating Hormone (TSH) Level
기간: From baseline to the end of the intervention at 8 weeks
Fasting morning serum TSH concentration measured by chemiluminescent immunoassay.
From baseline to the end of the intervention at 8 weeks
Functional Capacity
기간: From baseline to the end of the intervention at 8 weeks
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.
From baseline to the end of the intervention at 8 weeks
Total Sleep Time (Sleep Diary)
기간: From baseline to the end of the intervention at 8 weeks
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.
From baseline to the end of the intervention at 8 weeks
Total Sleep Time (Wearable Device)
기간: From baseline to the end of the intervention at 8 weeks
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.
From baseline to the end of the intervention at 8 weeks
Sleep Efficiency (Wearable Device)
기간: From baseline to the end of the intervention at 8 weeks
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 (%).
From baseline to the end of the intervention at 8 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Insomnia Severity
기간: 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.
From baseline to the end of the intervention at 8 weeks
Waist Circumference (cm)
기간: From baseline to the end of the intervention at 8 weeks
Waist circumference measured using a non-elastic tape measure.
From baseline to the end of the intervention at 8 weeks
Hip Circumference (cm)
기간: From baseline to the end of the intervention at 8 weeks
Hip circumference measured using a non-elastic tape measure.
From baseline to the end of the intervention at 8 weeks
Neck Circumference (cm)
기간: From baseline to the end of the intervention at 8 weeks
Neck circumference measured using a non-elastic tape measure.
From baseline to the end of the intervention at 8 weeks
Muscle Mass (kg)
기간: From baseline to the end of the intervention at 8 weeks
Muscle mass assessed using bioelectrical impedance analysis (BIA).
From baseline to the end of the intervention at 8 weeks
Body Fat Percentage (%)
기간: From baseline to the end of the intervention at 8 weeks
Body fat percentage assessed using bioelectrical impedance analysis (BIA).
From baseline to the end of the intervention at 8 weeks
Bone Mass (kg)
기간: From baseline to the end of the intervention at 8 weeks
Bone mass assessed using bioelectrical impedance analysis (BIA).
From baseline to the end of the intervention at 8 weeks
Body Water Percentage (%)
기간: From baseline to the end of the intervention at 8 weeks
Body water percentage assessed using bioelectrical impedance analysis (BIA).
From baseline to the end of the intervention at 8 weeks
Fatigue Severity
기간: 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.
From baseline to the end of the intervention at 8 weeks
Peripheral Muscle Strength
기간: From baseline to the end of the intervention at 8 weeks
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.
From baseline to the end of the intervention at 8 weeks
Physical Activity Level
기간: 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.
From baseline to the end of the intervention at 8 weeks
Health-related quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ)
기간: 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.
From baseline to the end of the intervention at 8 weeks
Patient Global Impression of Change
기간: 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.
At the end of the intervention (8 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Istanbul University - Cerrahpasa

수사관

  • 수석 연구원: MELİS USUL, Istanbul University - Cerrahpasa
  • 연구 책임자: Gökşen Kuran Aslan, Professor, Istanbul University - Cerrahpasa
  • 연구 의자: Esen Kıyan, Professor, Istanbul University Faculty of Medicine
  • 연구 의자: Zeynep Banu Güngör, Professor, Istanbul University - Cerrahpasa

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 12월 1일

연구 완료 (추정된)

2028년 2월 1일

연구 등록 날짜

최초 제출

2026년 5월 31일

QC 기준을 충족하는 최초 제출

2026년 6월 3일

처음 게시됨 (실제)

2026년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 3일

마지막으로 확인됨

2026년 6월 1일

추가 정보

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키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 3RQX7PDq

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아니요

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아니

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

신체 활동에 대한 임상 시험

Aerobic Exercise Training에 대한 임상 시험

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