Skip to main content
Clinical Trials/NCT04835558
NCT04835558
Completed
Not Applicable

Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome; Evaluation by Incremental Load Test

Istanbul University1 site in 1 country60 target enrollmentFebruary 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity Hypoventilation Syndrome (OHS)
Sponsor
Istanbul University
Enrollment
60
Locations
1
Primary Endpoint
Incremental load test
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Obesity hypoventilation syndrome (OHS) is defined as a combination of obesity [body mass index (BMI) ≥30 kg/m2], chronic daytime hypercapnia (PaCO2 >45 mm Hg), and sleep-apnea in the absence of other known causes of hypercapnia. Respiratory system compliance decreases and resistance increases in OHS. This causes increase in work of breathing and oxygen cost of breathing, which may result in respiratory muscle fatigue. Increase in respiratory workload and increase in resistance to respiration is expected to decrease in respiratory muscle endurance (RME) in subjects with OHS.

Detailed Description

In the literature, studies evaluating RME in subjects with OHS are limited. No study has been found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a control group, and to determine factors associated with respiratory muscle endurance.

Registry
clinicaltrials.gov
Start Date
February 5, 2018
End Date
January 24, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Goksen Kuran Aslan

Assoc. Prof.

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with OHS
  • Obese subjects (30 \< body mass index \< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3)

Exclusion Criteria

  • Severe respiratory disease
  • Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests

Outcomes

Primary Outcomes

Incremental load test

Time Frame: 1 day

Respiratory muscle endurance was evaluated by incremental load test. The incremental load test was performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).

Secondary Outcomes

  • 6 minute walk test(1 day)
  • Pittsburg Sleep Quality Index(1 day)
  • Fatigue Severity Scale(1 day)
  • EQ-5D Health-Related Quality of Life Questionnaire(1 day)
  • Obesity and Weight Loss Quality of Life Instrument(1 day)
  • Mouth pressure measurements(1 day)
  • Epworth Sleepiness Scale(1 day)

Study Sites (1)

Loading locations...

Similar Trials