A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)
Primary Purpose
Obesity Hypoventilation Syndrome
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Obesity Hypoventilation Syndrome
Eligibility 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
Sites / Locations
- Guy's and St Thomas' NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
NIV alone
Rehabilitation arm
Outcomes
Primary Outcome Measures
% Weight loss
Secondary Outcome Measures
6 minute walk test
Full Information
NCT ID
NCT01483716
First Posted
November 30, 2011
Last Updated
August 16, 2015
Sponsor
Guy's and St Thomas' NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01483716
Brief Title
A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
NIV alone
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Rehabilitation arm
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation
Primary Outcome Measure Information:
Title
% Weight loss
Time Frame
12 months
Secondary Outcome Measure Information:
Title
6 minute walk test
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Hart
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Guy's and St Thomas' NHS Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28971973
Citation
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.
Results Reference
derived
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A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)
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