A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)
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ClinicalTrials.gov Identifier: NCT01483716
Recruitment Status :
First Posted : December 1, 2011
Last Update Posted : August 18, 2015
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
Swapna Mandal, Guy's and St Thomas' NHS Foundation Trust
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of OHS
BMI > 30 kg/m2
Chronic hypercapnia , daytime PaCO2 >6kPa
Evidence of sleep disordered breathing on overnight studies
Tolerated NIV > 4hrs on 1st night during initiation of NIV
Hypercapnic respiratory failure secondary to an identifiable cause other than OHS.
Respiratory acidosis (pH <7.35)
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