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
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Melis Usul, PhD student
- Puhelinnumero: +(90)5364667235
- Sähköposti: melisausul1999@gmail.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Gökşen Kuran Aslan, Professor
- Puhelinnumero: +(90)5324095246
- Sähköposti: goksenkuran@yahoo.com
Opiskelupaikat
-
-
-
Istanbul, Turkki (Türkiye)
- Istanbul University-Cerrahpaşa, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye
-
Ottaa yhteyttä:
- Melis Usul
- Puhelinnumero: +(90)5364667235
- Sähköposti: melisausul1999@gmail.com
-
Päätutkija:
- Melis USUL
-
Alatutkija:
- Gökşen Kuran Aslan
-
Alatutkija:
- Esen Kıyan
-
Alatutkija:
- Zeynep Banu Güngör
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Active Comparator: Aerobic Exercise Group
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.
|
|
Kokeellinen: Exercise Snacks Group
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.
|
|
Ei väliintuloa: Control Group (Usual Care)
Usual Care
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI) Total Score
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Insomnia Severity
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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 (%)
Aikaikkuna: 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)
Aikaikkuna: 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 (%)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: MELİS USUL, Istanbul University - Cerrahpasa
- Opintojohtaja: Gökşen Kuran Aslan, Professor, Istanbul University - Cerrahpasa
- Opintojen puheenjohtaja: Esen Kıyan, Professor, Istanbul University Faculty of Medicine
- Opintojen puheenjohtaja: Zeynep Banu Güngör, Professor, Istanbul University - Cerrahpasa
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 3RQX7PDq
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .