A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)

Guy's and St Thomas' NHS Foundation Trust

Status

Completed

Conditions

Obesity Hypoventilation Syndrome

Treatments

Behavioral: Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT01483716

11/LO/1481

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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