A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Hypoventilation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

NIV alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Rehabilitation arm

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type BEHAVIORAL

Interventions

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Rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No