Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT04835558

Collaborator

(none)

Enrollment

Location

11.6

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Hypoventilation Syndrome (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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 5, 2018

Actual Primary Completion Date :

Nov 5, 2018

Actual Study Completion Date :

Jan 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group I Subjects with obesity hypoventilation sydrome (30 < body mass index < 40 kg/m2)
Group II Subjects with obesity hypoventilation sydrome (body mass index > 40 kg/m2)
Control Group Age and sex-matched obese subjects (30 < body mass index < 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score < 3)

Outcome Measures

Primary Outcome Measures

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

Mouth pressure measurements [1 day]
Respiratory muscle strength was measured using mouth pressure measurements (Micro Medical MicroRPM).
6 minute walk test [1 day]
The 6 minute walk test was used to evaluate the functional exercise capacity of the subjects.
Epworth Sleepiness Scale [1 day]
Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. A score of >10 accepted as daytime sleepiness.
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.