Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome

Obesity Hypoventilation Syndrome (OHS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04835558
• Other study ID #: 29713
• Status: Completed
• Start date: February 5, 2018
• Est. completion date: January 24, 2019

Study information

• Verified date: April 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 24, 2019
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Obesity Hypoventilation Syndrome (OHS)
• Syndrome

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental load test	Respiratory muscle endurance was evaluated by incremental load test. The incremental load test was performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).	1 day
Secondary	Mouth pressure measurements	Respiratory muscle strength was measured using mouth pressure measurements (Micro Medical MicroRPM).	1 day
Secondary	6 minute walk test	The 6 minute walk test was used to evaluate the functional exercise capacity of the subjects.	1 day
Secondary	Epworth Sleepiness Scale	Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. A score of >10 accepted as daytime sleepiness.	1 day
Secondary	Pittsburg Sleep Quality Index	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.	1 day
Secondary	Fatigue Severity Scale	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.	1 day
Secondary	EQ-5D Health-Related Quality of Life Questionnaire	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.	1 day
Secondary	Obesity and Weight Loss Quality of Life Instrument	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.	1 day