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
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Melis Usul, PhD student
- Telefonnummer: +(90)5364667235
- E-post: melisausul1999@gmail.com
Studer Kontakt Backup
- Navn: Gökşen Kuran Aslan, Professor
- Telefonnummer: +(90)5324095246
- E-post: goksenkuran@yahoo.com
Studiesteder
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Istanbul, Tyrkia (Türkiye)
- Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye
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Ta kontakt med:
- Melis Usul
- Telefonnummer: +(90)5364667235
- E-post: melisausul1999@gmail.com
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Hovedetterforsker:
- Melis USUL
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Underetterforsker:
- Gökşen Kuran Aslan
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Underetterforsker:
- Esen Kıyan
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Underetterforsker:
- Zeynep Banu Güngör
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
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Aktiv komparator: 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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Eksperimentell: 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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Ingen inngripen: Control Group (Usual Care)
Usual Care
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Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI) Total Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Insomnia Severity
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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 (%)
Tidsramme: 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)
Tidsramme: 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 (%)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Etterforskere
Etterforskere
- Hovedetterforsker: MELİS USUL, Istanbul University - Cerrahpasa
- Studieleder: Gökşen Kuran Aslan, Professor, Istanbul University - Cerrahpasa
- Studiestol: Esen Kıyan, Professor, Istanbul University Faculty of Medicine
- Studiestol: Zeynep Banu Güngör, Professor, Istanbul University - Cerrahpasa
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
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