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Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04835558
Enrollment
60
Registered
2021-04-08
Start date
2018-02-05
Completion date
2019-01-24
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Hypoventilation Syndrome (OHS)

Keywords

Respiratory Muscle Endurance, Sleep, Fatigue, Quality of Life

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.

Interventions

None listed

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incremental load test1 dayRespiratory muscle endurance was evaluated by incremental load test. The incremental load test was performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).

Secondary

MeasureTime frameDescription
6 minute walk test1 dayThe 6 minute walk test was used to evaluate the functional exercise capacity of the subjects.
Epworth Sleepiness Scale1 dayExcessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. A score of \>10 accepted as daytime sleepiness.
Pittsburg Sleep Quality Index1 daySleep 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.
Mouth pressure measurements1 dayRespiratory muscle strength was measured using mouth pressure measurements (Micro Medical MicroRPM).
EQ-5D Health-Related Quality of Life Questionnaire1 dayQuality 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 Instrument1 dayQuality 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.
Fatigue Severity Scale1 dayFatigue 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026