Exercise Interventions in Obstructive Sleep Apnea Syndrome
The Effect of Exercise Snacks and Aerobic Exercise on Circadian Rhythm and Functional Capacity in Individuals With Obstructive Sleep Apnea Syndrome
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Melis Usul, PhD student
- Phone Number: +(90)5364667235
- Email: melisausul1999@gmail.com
Study Contact Backup
- Name: Gökşen Kuran Aslan, Professor
- Phone Number: +(90)5324095246
- Email: goksenkuran@yahoo.com
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye
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Contact:
- Melis Usul
- Phone Number: +(90)5364667235
- Email: melisausul1999@gmail.com
-
Principal Investigator:
- Melis USUL
-
Sub-Investigator:
- Gökşen Kuran Aslan
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Sub-Investigator:
- Esen Kıyan
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Sub-Investigator:
- Zeynep Banu Güngör
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: 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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Experimental: 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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No Intervention: Control Group (Usual Care)
Usual Care
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI) Total Score
Time Frame: 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
Time Frame: 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.
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From baseline to the end of the intervention at 8 weeks
|
|
Morningness-Eveningness Questionnaire (MEQ) Total Score
Time Frame: 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.
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From baseline to the end of the intervention at 8 weeks
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|
Serum Cortisol Level
Time Frame: From baseline to the end of the intervention at 8 weeks
|
Fasting morning serum cortisol concentration measured by chemiluminescent immunoassay.
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From baseline to the end of the intervention at 8 weeks
|
|
Serum Thyroid-Stimulating Hormone (TSH) Level
Time Frame: From baseline to the end of the intervention at 8 weeks
|
Fasting morning serum TSH concentration measured by chemiluminescent immunoassay.
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From baseline to the end of the intervention at 8 weeks
|
|
Functional Capacity
Time Frame: 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
|
|
Total Sleep Time (Sleep Diary)
Time Frame: 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.
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From baseline to the end of the intervention at 8 weeks
|
|
Total Sleep Time (Wearable Device)
Time Frame: 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.
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From baseline to the end of the intervention at 8 weeks
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Sleep Efficiency (Wearable Device)
Time Frame: 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
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insomnia Severity
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 (%)
Time Frame: From baseline to the end of the intervention at 8 weeks
|
Body fat percentage assessed using bioelectrical impedance analysis (BIA).
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From baseline to the end of the intervention at 8 weeks
|
|
Bone Mass (kg)
Time Frame: From baseline to the end of the intervention at 8 weeks
|
Bone mass assessed using bioelectrical impedance analysis (BIA).
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From baseline to the end of the intervention at 8 weeks
|
|
Body Water Percentage (%)
Time Frame: 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
|
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Fatigue Severity
Time Frame: 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
Time Frame: 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
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|
Physical Activity Level
Time Frame: 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
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Health-related quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ)
Time Frame: 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
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Patient Global Impression of Change
Time Frame: At the end of the intervention (8 weeks)
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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)
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: MELİS USUL, Istanbul University - Cerrahpasa
- Study Director: Gökşen Kuran Aslan, Professor, Istanbul University - Cerrahpasa
- Study Chair: Esen Kıyan, Professor, Istanbul University Faculty of Medicine
- Study Chair: Zeynep Banu Güngör, Professor, Istanbul University - Cerrahpasa
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 3RQX7PDq
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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