Randomized, Parallel and Controled Clinical Trial to Assess the Effect of the Physical Activity Promotion During 12 Months on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Apnea-hypopnea index
研究概览
简要总结
Main objective: To assess the effect of the daily physical activity promotion with a pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to moderate obstructive sleep apnea (OSA).
Study patients. Subjects 30-80 years old with diagnosis of mild-moderate OSA (AHI: 5-30 and predominance of obstructive events [>80%)].
Design. Randomized, parallel and open-label clinical trial, controlled with conventional treatment.
Intervention: Patients will be randomized (1:1) to control group [treatment and follow-up according to conventional clinical practice] or intervention group [in addition to conventional treatment and follow-up, the patients will receive a pedometer to measure the number of steps walked daily. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol (<6000 steps/day: increase by 3000 steps/day; 6000 - 10000 steps/day: reach 10000 steps/day; and > 10000 steps/day: maintain or increase steps).
Measurements. At , 12, 24 and 52 weeks of randomization, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms, comorbidities, current medication); questionnaires (ESS, FOSQ, SF-12, EuroQoL and iPAZ); heart rate and blood pressure; analytical determinations (HbA1c, HOMA index, cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, homocysteine, NT-proBNP and hsCRP); plasmatic biomarkers (8-isoprostane, IL1beta, IL6, IL8 and TNFalpha); and evaluation of daily physical activity using an accelerometer.
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
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 30 to 80 years
- •Diagnosis of mild-moderate obstructive sleep apnea [apnea-hypopnea index 5-30 h-1] by polysomnography or respiratory polygraphy
- •Predominance of obstructive events (> 80%)
- •Signature of informed consent
排除标准
- •Previous diagnosis of chronic obstructive pulmonary disease, asthma, diffuse interstitial lung disease or chest wall disease.
- •Evidence of central apneas, hypoventilation syndrome or respiratory failure
- •Previous diagnosis of refractory arterial hypertension, congestive heart failure, ischemic heart disease or cerebro-vascular disease.
- •Neurological or osteoarticular limitation that prevents ambulation.
- •Professional drivers or occupational risk or respiratory
- •Previous treatment with CPAP
- •Participation in another clinical trial in the 30 days prior to randomization.
结局指标
主要结局
Apnea-hypopnea index
时间窗: 12 months
To compare the apnea-hypopnea index of patients with mild-moderate obstructive sleep apnea between conventional treatment or conventional treatment plus daily physical activity promotion with a pedometer
次要结局
- Nocturnal oxyhemoglobin saturation(12 months)
- Physical activity level(12 months)
- Baseline determinants of physical activity(12 months)
- Body composition(12 months)
- Diurnal sleepiness(12 months)
- Functional impact(12 months)
- Systematic Coronary Risk Evaluation(12 months)
- Insulin sensitivity(12 months)
- Oxidative stress(12 months)
- Systemic inflammation(12 months)
研究者
Francisco Garcia-Rio
MD, PhD
Hospital Universitario La Paz