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Completed

NCT Number: NCT04835558

Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome

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.

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Key information

Conditions

Obesity Hypoventilation Syndrome (OHS) Apnea Dyssomnias Fatigue Hypoventilation Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Hypoventilation Syndrome Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

24 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Mouth pressure measurements

    Time frame: 1 day

    Respiratory muscle strength was measured using mouth pressure measurements (Micro Medical MicroRPM).

  2. 6 minute walk test

    Time frame: 1 day

    The 6 minute walk test was used to evaluate the functional exercise capacity of the subjects.

  3. Epworth Sleepiness Scale

    Time frame: 1 day

    Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. A score of >10 accepted as daytime sleepiness.

  4. Pittsburg Sleep Quality Index

    Time frame: 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.

  5. Fatigue Severity Scale

    Time frame: 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.

  6. EQ-5D Health-Related Quality of Life Questionnaire

    Time frame: 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.

  7. Obesity and Weight Loss Quality of Life Instrument

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 8, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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