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A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483716
First Posted: December 1, 2011
Last Update Posted: August 18, 2015
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.
Information provided by (Responsible Party):
Swapna Mandal, Guy's and St Thomas' NHS Foundation Trust
  Purpose
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 Intervention
Obesity Hypoventilation Syndrome Behavioral: Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Swapna Mandal, Guy's and St Thomas' NHS Foundation Trust:

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

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

Enrollment: 37
Study Start Date: November 2011
Study Completion Date: August 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
NIV alone
Experimental: Intervention
Rehabilitation arm
Behavioral: Rehabilitation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01483716


Locations
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
Investigators
Study Director: Nicholas Hart Guy's and St Thomas' NHS Foundation Trust
  More Information

Responsible Party: Swapna Mandal, Clinical Research Fellow, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01483716     History of Changes
Other Study ID Numbers: 11/LO/1481
First Submitted: November 30, 2011
First Posted: December 1, 2011
Last Update Posted: August 18, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Syndrome
Obesity
Hypoventilation
Obesity Hypoventilation Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases