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A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01483716
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : August 18, 2015
Information provided by (Responsible Party):
Swapna Mandal, Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Obesity Hypoventilation Syndrome Behavioral: Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
No Intervention: Control
NIV alone
Experimental: Intervention
Rehabilitation arm
Behavioral: Rehabilitation

Primary Outcome Measures :
  1. % Weight loss [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01483716

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United Kingdom
Guy's and St Thomas' NHS Trust
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
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Study Director: Nicholas Hart Guy's and St Thomas' NHS Foundation Trust
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Swapna Mandal, Clinical Research Fellow, Guy's and St Thomas' NHS Foundation Trust Identifier: NCT01483716    
Other Study ID Numbers: 11/LO/1481
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Obesity Hypoventilation Syndrome
Pathologic Processes
Nutrition Disorders
Body Weight
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases