A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)

Obesity Hypoventilation Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483716
• Other study ID #: 11/LO/1481
• Status: Completed
• Phase: N/A
• First received: November 30, 2011
• Last updated: August 16, 2015
• Start date: November 2011
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoventilation
• Obesity Hypoventilation Syndrome

Intervention

Behavioral:
• Rehabilitation

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Weight loss		12 months	No
Secondary	6 minute walk test		12 months	No