A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- % Weight loss
研究概览
简要总结
Obesity is an escalating problem in the UK and a proportion of these patients have a condition known as Obesity Hypoventilation Syndrome (OHS). This syndrome is associated with symptoms of breathlessness, reduction in exercise capacity, fatigue and headaches. Previous research has shown that patients with this condition tend to use healthcare services more frequently and are often at risk of other diseases such as diabetes mellitus and high blood pressure. Currently, the mainstay of treatment is noninvasive ventilation (NIV), this is a mask ventilator that patients use overnight to improve oxygen levels and remove carbon dioxide (the waste gas of breathing), however this does not fully treat the underlying problem. The research group has shown that NIV helps improve activity and contributes to weight loss in this group of patients. The aim of this research will be to investigate the effect of an exercise and nutrition programme in addition to NIV on weight loss and activity levels compared to NIV alone.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OHS
- •BMI > 30 kg/m2
- •Chronic hypercapnia , daytime PaCO2 >6kPa
- •FEV1/FVC ≥70%
- •Evidence of sleep disordered breathing on overnight studies
- •Tolerated NIV > 4hrs on 1st night during initiation of NIV
排除标准
- •Hypercapnic respiratory failure secondary to an identifiable cause other than OHS.
- •Respiratory acidosis (pH <7.35)
- •Wheelchair/bedbound patients
- •Cognitive impairment which would prevent the subject from complying with trial protocol
- •Unstable coronary artery syndrome
- •Patients postintubation or decannulation following treatment requiring acute hypercapnic respiratory failure
- •Patients undergoing renal replacement therapy
- •Critical peripheral vascular disease
- •Disabling locomotor disability preventing participation in exercises involved in the rehabilitation programme
- •Pregnancy
- •Bariatric surgery planned within 3 months
结局指标
主要结局
% Weight loss
时间窗: 12 months
次要结局
- 6 minute walk test(12 months)
研究者
Swapna Mandal
Clinical Research Fellow
Guy's and St Thomas' NHS Foundation Trust
