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A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)

This study is currently recruiting participants.
Verified November 2011 by Guy's and St Thomas' NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Swapna Mandal, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01483716
First received: November 30, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • % Weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6 minute walk test [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Study Start Date: November 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Behavioral: Rehabilitation
Experimental: Intervention
Rehabilitation arm
 Behavioral: Rehabilitation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483716

Contacts
Contact: Swapna Mandal, MBBS 02071888070 swapna.mandal@gstt.nhs.uk

Locations
United Kingdom
Guy's and St Thomas' NHS Trust Recruiting
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

No publications provided

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
Study First Received: November 30, 2011
Last Updated: November 30, 2011
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on June 18, 2013