Effects of Different Exercise Modalities on Apnea-Hypopnea Index and Oxidative Stress in Patients With Obstructive Sleep Apnea.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The objective of this study was to compare different exercise modalities (moderate continuous intensity training, high intensity interval training, and inspiratory muscle training) on Apnea-Hypopnea index and oxidative stress in patients with Obstructive sleep apnea.
详细描述
Forty patients with OSA aged 20 and 50 years old, dividing into 4 groups (MICT, HIIT, IMT, and CON) by stratified (with sex, age, and OSA severity) and single random sampling. The MICT group received 50 minutes of running at 65-70% of maximum heart rate 3 days/week for 12 weeks. The HIIT groups received 28 minutes of running (High intensity at 85-90% of maximum heart rate 2 minutes interval with low intensity 50-55% of maximum heart rate 2 minutes) 3 days/week for 12 weeks. The IMT group received Powerbreathe ® device, performing 240 breath (8 sets) per day at 50% of Maximal inspiratory pressure (MIP), 5 days/week for 12 week. The CON group did not have any intervention but usual care. Data collection was split 2 days (1st day for polysomnography evaluation, and 2nd day for questionnaire, blood collection, body composition, exhaled nitric oxide, pulmonary function, respiratory muscle strength and aerobic capacity). All variables were measured before and after exercise program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with mild (AHI 5-15) or moderate (AHI 15-30) OSA, aged between 20 - 50 years.
- •BMI between 18.5 - 24.9 kg/ m
- •No history of exercise more than 150 min/week for 4 weeks.
- •No used CPAP or discontinue at least 2 weeks.
- •No history for surgery for OSA treatment. Screened by physician that patients have not had Uncontrolled diabetes (blood sugar 180 mg/dL) Uncontrolled hypertension (BP 139/89 mmHg) Any coronary artery disease Any neuromuscular disease Chronic Obstructive Pulmonary Disease; COPD Any cognitive disease Other sleep-related disorders Cancer
- •Not a person with current smoker, menopause or pregnancy.
- •Stable medication.
- •Willing to participate in this research.
排除标准
- •Cannot participate at least 80% of exercise program.
- •Inevitable event (injury, sickness, etc.)
- •Unwilling to continue this research.
结局指标
主要结局
The Pittsburgh Sleep Quality Index (PSQI)
时间窗: Change from Baseline Sleep-related and Quality of Life by The Pittsburgh Sleep Quality Index (PSQI) questionnaire at 12 weeks.
The Pittsburgh Sleep Quality Index (PSQI) Thai version was evaluated at baseline and post-intervention to assess subjective sleep quality over the previous 2 weeks. This index aimed to evaluate their subjective sleep quality over the preceding two weeks. The PSQI provided seven component scores, which included assessments of sleep quality, the time taken to fall asleep, the duration of sleep, the regularity of sleep, disturbances during sleep, the use of sleep medications, and daytime dysfunction. By summing up the scores from these subscales, a global score ranging from 0 to 21 was calculated. A global score above 5 is generally considered an indication of poor sleep quality.
Apnea-Hypopnea index (event/hr)
时间窗: Change from Baseline Apnea-Hypopnea index at 12 weeks.
The study performed polysomnography in the sleep laboratory using standard EEG with frontal leads (F1, F2), central leads (C3, C4), occipital leads (O1, O2), and reference leads at mastoids (M1, M2). Electromyography and electrooculography were also used. Oxygen saturation (SpO2) was measured using a finger probe. Air flow was measured using two methods: a nasal pressure transducer and an oral-nasal thermocouple. Respiratory movements of the thorax and abdomen were monitored using respiratory inductance plethysmography. The position of the body was measured using a position sensor attached to the anterior chest wall on the thoracic belt.
Oxidative stress
时间窗: Change from Baseline Oxidative stress at 12 weeks.
Blood was collected into sterile ethylenediaminetetraacetic acid (EDTA) tubes from the cubital vein by a nurse at Exercise Physiology laboratory, Chulalongkorn University. The collected blood was analyzed by a medical technologist. To obtain plasma, the EDTA blood samples were centrifuged at 3,000 rpm for 10 minutes. All plasma samples were stored at a temperature of -80°C until they were used for various assays.
The Short Form-36 (SF-36) questionnaire
时间窗: Change from Baseline Sleep-related and Quality of Life by The The Short Form-36 (SF-36) questionnaire at 12 weeks.
The Short Form-36 (SF-36) questionnaire Thai version was evaluated at baseline and post-intervention. This questionnaire consists of 36 questions that are used to assess quality of life (QoL) across eight domains related to both physical and mental health. These domains include physical functioning, role limitations due to physical health (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional health (role-emotional), and mental health. Each domain is scored on a scale of 0 to 100, where higher scores indicate a better health-related quality of life (HRQL) compared to lower scores.
The Functional Outcomes of Sleep Questionnaire (FOSQ)
时间窗: Change from Baseline Sleep-related and Quality of Life by The Functional Outcomes of Sleep Questionnaire (FOSQ) at 12 weeks.
The Functional Outcomes of Sleep Questionnaire (FOSQ) Thai version was evaluated at baseline and post-intervention. This questionnaire specifically designed to assess health-related quality of life in relation to sleep disorders. It comprises 30 items that examine five domains related to normal daily life: general productivity (8 items), vigilance (7 items), social outcome (2 items), activity level (9 items), and sexual relationship (4 items). Each subscale and a global score were calculated, with the subscale scores ranging from 1 to 4 and the global score ranging from 5 to 20. A lower score indicates a higher level of dysfunction or poorer quality of life.
The Epworth sleepiness scale (ESS)
时间窗: Change from Baseline Sleep-related and Quality of Life by The Epworth sleepiness scale (ESS) Questionnaire at 12 weeks.
The Epworth sleepiness scale (ESS) Thai version was evaluated at baseline and post-intervention. This questionnaire is used to assess excessive daytime sleepiness (EDS). The questionnaire consists of eight scenarios where individuals rate their potential for dozing off or falling asleep on a scale of 0 to 3. The ESS has demonstrated excellent internal consistency and test-retest reliability, making it suitable for assessing the effectiveness of interventions. A total ESS score greater than 10 indicates the presence of EDS and a high risk of sleep-related breathing disorders.
次要结局
- Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)(Change from baseline FEV1/FVC at 12 weeks.)
- Pulmonary function (Forced expiratory flow at 25 - 75% of FVC; FEF25-75%)(Change from baseline FEF25-75% at 12 weeks.)
- Pulmonary function (Maximal voluntary ventilation; MVV)(Change from baseline MVV at 12 weeks.)
- Exhaled nitric oxide (ppb)(Change from baseline Exhaled nitric oxide at 12 weeks.)
- Pulmonary function (Forced Expiratory Volume in one second; FEV1)(Change from baseline FEV1 at 12 weeks.)
- Respiratory muscle strength(Change from baseline Respiratory muscle strength at 12 weeks.)
- Pulmonary function (Forced vital capacity; FVC)(Change from baseline FVC at 12 weeks.)
- Pulmonary function (Peak expiratory flow; PEF)(Change from baseline PEF at 12 weeks.)
- Aerobic capacity (ml/kg/min)(Change from baseline Aerobic capacity at 12 weeks.)