Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift in Patients Who Can't Use CPAP or MAD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Apnea-Hypopnea index
研究概览
简要总结
Obstructive sleep apnea (OSA) is characterized by complete or partial upper-airway collapse during sleep associated with sleepiness. OSA causes severe impairments in quality of life (sleepiness, tiredness, concentration difficulties). Moreover, OSA has adverse consequences on the cardiovascular system by causing intermittent hypoxia, increased sympathetic nervous system activation and vascular endothelial dysfunction.
Continuous Positive Airway Pressure (CPAP) and mandibular advanced devices (MAD) remain the two first-line therapies for OSA. However, not all patients are eligible for these treatments or are not able to follow for a lifelong therapy and therefore do not use it consistently.
A recent meta-analysis has confirmed that regular physical activity reduces OSA by approximately 28% (Mendelson et al. 2018). However, an important inter-individual variability exists and no study to date has identified characteristics of patients who respond to these interventions.
The aim of this Prospective study, single-site, non-randomized 4-week trial is to evaluate the impact of a 4-week physical activity intervention on the apnea-hypopnea index (AHI) in OSA patients based on their baseline fluid shift level.
Participants included in the present study will benefit from a 4-week physical activity intervention. Upon the initial visit, a physical activity prescription will be defined and they will be equipped with a physical activity monitor that allows feedback. Participants will then exercise one day per week on-site and 4 days/week on their own. Weekly physical activity will be reviewed weekly with the participant during their on-site visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patient aged 18 to 80 years old
- •Patient with OSA (AHI ≥ 15 events/hr)
- •Patient not receiving any treatment for their OSA
- •Patient able to provide written informed consent
- •Patient able to participate in regular physical activity (no medical contraindication to exercise)
排除标准
- •• Pregnancy
- •Person deprived of liberty or subject to a legal protection measure
- •Patient presenting a condition that can influence the results. (According to the investigator's judgment, i.e. heart failure, venous insufficiency).
- •Vulnerable person or legally protected adult.
- •Patients already included in another interventional study
- •BMI > 30 kg/m²
- •Patient taking diuretics
结局指标
主要结局
Apnea-Hypopnea index
时间窗: Baseline-4weeks
Measured during polysomnography
次要结局
- Subjective sleepiness as measured by the Epworth Sleepiness Score(Baseline-4weeks)
- Overnight change in leg fluid volume(Baseline-4weeks)
- Quality of life assessed by the SF-36 questionnaire(Baseline-4weeks)
