Exercise Interventions in Obstructive Sleep Apnea Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic Exercise Training
BehavioralParticipants 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.
Exercise Snacking
BehavioralThe 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.
Treatment groups
39 Participants
are divided into 3 treatment groupsGroup A: Aerobic Exercise GroupActive comparator 1 intervention
Group B: Exercise Snacks GroupExperimental treatment 1 intervention
Group C: Control Group (Usual Care)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pittsburgh Sleep Quality Index (PSQI) Total Score
Sleep quality assessed using the Pittsburgh Sleep Quality Index. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame
From baseline to the end of the intervention at 8 weeks2
Epworth Sleepiness Scale (ESS) Total Score
Daytime sleepiness will be assessed using the Epworth Sleepiness Scal (ESS).Scores ≥10 indicate excessive daytime sleepiness.
Time frame
From baseline to the end of the intervention at 8 weeks3
Morningness-Eveningness Questionnaire (MEQ) Total Score
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.
Time frame
From baseline to the end of the intervention at 8 weeks4
Serum Cortisol Level
Fasting morning serum cortisol concentration measured by chemiluminescent immunoassay.
Time frame
From baseline to the end of the intervention at 8 weeksSecondary outcomes
1
Insomnia Severity
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.
Time frame
From baseline to the end of the intervention at 8 weeks2
Waist Circumference (cm)
Waist circumference measured using a non-elastic tape measure.
Time frame
From baseline to the end of the intervention at 8 weeks3
Hip Circumference (cm)
Hip circumference measured using a non-elastic tape measure.
Time frame
From baseline to the end of the intervention at 8 weeks4
Neck Circumference (cm)
Neck circumference measured using a non-elastic tape measure.
Time frame
From baseline to the end of the intervention at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov
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