Clinical trial NCT01483716: A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Hypoventilation Syndrome
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of OHS
* Age \>18
* 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

Exclusion Criteria:

* Hypercapnic respiratory failure secondary to an identifiable cause other than OHS.
* Age \<18
* 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

Primary outcomes:
measure: % Weight loss
timeFrame: 12 months
Secondary outcomes:
measure: 6 minute walk test
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Nicholas Hart
role: STUDY_DIRECTOR
References:
citation: Mandal S, Suh ES, Harding R, Vaughan-France A, Ramsay M, Connolly B, Bear DE, MacLaughlin H, Greenwood SA, Polkey MI, Elliott M, Chen T, Douiri A, Moxham J, Murphy PB, Hart N. Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO): a pilot randomised controlled trial. Thorax. 2018 Jan;73(1):62-69. doi: 10.1136/thoraxjnl-2016-209826. Epub 2017 Sep 29.