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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.
 
ClinicalTrials.gov Identifier: NCT01483716
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Swapna Mandal, Guy's and St Thomas' NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE November 30, 2011
First Posted Date  ICMJE December 1, 2011
Last Update Posted Date August 18, 2015
Study Start Date  ICMJE November 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
% Weight loss [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
6 minute walk test [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity Hypoventilation Syndrome
Intervention  ICMJE Behavioral: Rehabilitation
Study Arms  ICMJE
  • No Intervention: Control
    NIV alone
  • Experimental: Intervention
    Rehabilitation arm
    Intervention: Behavioral: Rehabilitation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2015)
37
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01483716
Other Study ID Numbers  ICMJE 11/LO/1481
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Swapna Mandal, Guy's and St Thomas' NHS Foundation Trust
Study Sponsor  ICMJE Guy's and St Thomas' NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nicholas Hart Guy's and St Thomas' NHS Foundation Trust
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP