Effects of a Lifestyle Intervention on Quality of Life, Weight Loss and Cardiovascular Risk in Patients With Obstructive Sleep Apnoea Established on Continuous Positive Airway Pressure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Incremental shuttle walk performance
研究概览
简要总结
Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by interrupted breathing while sleeping. It is associated with cardiovascular problems such as high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are overweight and have impaired quality of life. Lifestyle interventions incorporating exercise training, dietary advice and behaviour change have been shown to elicit favourable changes in quality of life, body mass/composition and cardiovascular risk in a range of patient groups. However, no study has investigated the impact of lifestyle modification on such health outcomes in patients with OSAHS. This study will address this issue by investigating the effects of a lifestyle intervention on quality of life, body mass/composition and cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the intervention group will be offered a 12-week individualised lifestyle programme consisting of supervised exercise training, dietary advice and behaviour change counselling. Patients in the control group will receive an educational booklet detailing healthy eating and exercise guidelines but no supervised or structured intervention. The results of this study will inform the design of a larger, multi-centre randomised controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obstructive sleep apnoea patients who have been receiving CPAP therapy for at least 6 months and are known to be adherent to the treatment (>75% nightly use per week)
- •clinically obese (body mass index >30)
- •age 18-85 years
- •able to undertake exercise testing and training
排除标准
- •patients with any contraindications to exercise (e.g. severe hypertension, unstable arrhythmias, severe musculoskeletal injuries)
- •unable to undertake the requirements of the study
- •non-English speaking
- •already undertaking >30 min exercise >3 times per week
- •non-compliant with CPAP
- •body mass index <30
- •unable to provide written informed consent
结局指标
主要结局
Incremental shuttle walk performance
时间窗: 25 weeks
Body mass
时间窗: 25 weeks
次要结局
- Quality of life (EQ-5D and EQ-VAS)(13 and 25 weeks)
- Body fat percentage(13 and 25 weeks)
- Resting blood pressure(13 and 25 weeks)
- Blood markers (glucose, insulin, lipids, CRP)(13 and 25 weeks)
研究者
Garry Tew
Senior Research Fellow
Sheffield Teaching Hospitals NHS Foundation Trust