Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome

Completed

• Conditions: Obesity Hypoventilation Syndrome (OHS)

• Registration Number: NCT04835558
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2018-02-05
• Primary Completion: 2018-11-05
• Study Completion: 2019-01-24
• Study First Submitted: 2021-03-28
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-04
• Last Update Submitted: 2021-04-04
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incremental load test	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 Outcome Measures

Name	Time	Method
6 minute walk test	1 day	The 6 minute walk test was used to evaluate the functional exercise capacity of the subjects.
Pittsburg Sleep Quality Index	1 day	Sleep quality was assessed with the Pittsburg Sleep Quality Index. The total score were interpreted as follows: 0-5 indicated good sleep quality, \> 5 indicated poor sleep quality, and \>10 indicated the presence of a sleep disorder.
Fatigue Severity Scale	1 day	Fatigue severity was assessed with the Fatigue Severity Scale. This seven-likert scale was used for each item and final score was accepted as mean value of the 9 items. The higher scores indicated higher fatigue severity.
EQ-5D Health-Related Quality of Life Questionnaire	1 day	Quality of life was assessed with the EQ-5D Health-Related Quality of Life Questionnaire. The maximum score of 1 indicates the best health state, and higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status in which 100 indicates the best health status.
Obesity and Weight Loss Quality of Life Instrument	1 day	Quality of life specific to obesity was assessed with the Obesity and Weight Loss Quality of Life Instrument. As the total score from the scale approaches 0, the quality of life decreases, and as it approaches 100, the quality of life increases.
Mouth pressure measurements	1 day	Respiratory muscle strength was measured using mouth pressure measurements (Micro Medical MicroRPM).
Epworth Sleepiness Scale	1 day	Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. A score of \>10 accepted as daytime sleepiness.

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Turkey