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
Studie Overzicht
Toestand
Toestand
Conditie
Conditie
Interventie / Behandeling
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Studietype
Inschrijving (Geschat)
Inschrijving
Fase
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
Studiecontact
- Naam: Melis Usul, PhD student
- Telefoonnummer: +(90)5364667235
- E-mail: melisausul1999@gmail.com
Studie Contact Back-up
- Naam: Gökşen Kuran Aslan, Professor
- Telefoonnummer: +(90)5324095246
- E-mail: goksenkuran@yahoo.com
Studie Locaties
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Istanbul, Turkije (Türkiye)
- Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye
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Contact:
- Melis Usul
- Telefoonnummer: +(90)5364667235
- E-mail: melisausul1999@gmail.com
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Hoofdonderzoeker:
- Melis USUL
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Onderonderzoeker:
- Gökşen Kuran Aslan
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Onderonderzoeker:
- Esen Kıyan
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Onderonderzoeker:
- Zeynep Banu Güngör
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Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
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Actieve vergelijker: 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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Experimenteel: 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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Geen tussenkomst: Control Group (Usual Care)
Usual Care
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Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI) Total Score
Tijdsspanne: From baseline to the end of the intervention at 8 weeks
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Insomnia Severity
Tijdsspanne: From baseline to the end of the intervention at 8 weeks
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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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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 (%)
Tijdsspanne: 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)
Tijdsspanne: 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 (%)
Tijdsspanne: From baseline to the end of the intervention at 8 weeks
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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
Tijdsspanne: From baseline to the end of the intervention at 8 weeks
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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
Tijdsspanne: 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
Tijdsspanne: From baseline to the end of the intervention at 8 weeks
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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)
Tijdsspanne: From baseline to the end of the intervention at 8 weeks
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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
Tijdsspanne: 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.
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At the end of the intervention (8 weeks)
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Medewerkers en onderzoekers
Sponsor
Sponsor
Onderzoekers
Onderzoekers
- Hoofdonderzoeker: MELİS USUL, Istanbul University - Cerrahpasa
- Studie directeur: Gökşen Kuran Aslan, Professor, Istanbul University - Cerrahpasa
- Studie stoel: Esen Kıyan, Professor, Istanbul University Faculty of Medicine
- Studie stoel: Zeynep Banu Güngör, Professor, Istanbul University - Cerrahpasa
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Studie start
Primaire voltooiing (Geschat)
Primaire voltooiing
Studie voltooiing (Geschat)
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Eerst geplaatst
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update geplaatst
Laatste update ingediend die voldeed aan QC-criteria
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
Andere studie-ID-nummers
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