Clinical trial NCT06142513: The Effect of Obesity Hypoventilation Syndrome on Exercise Capacity, Peripheral Muscle Strength, and Quality of Life in Obese Individuals
Official title: The Effect of Obesity Hypoventilation Syndrome on Exercise Capacity, Peripheral Muscle Strength, and Quality of Life in Obese Individuals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity Hypoventilation Syndrome
Obesity
Hypoventilation
Respiration Disorders
Sleep Disorder; Breathing-Related
Keywords: Obesity
Obesity Hypoventilation Syndrome
Exercise Capacity
Quality of Life
Peripheral Muscle Strength
Quality of Sleep
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2023-11-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Obesity Hypoventilation Syndrome who are followed up in Istanbul University, Istanbul Faculty of Medicine, Department of Chest Diseases and obese individuals who are followed up in Istanbul University, Istanbul Faculty of Medicine, Department of Internal Diseases and who are in the low risk group according to stop bang evaluation will be included in the study.

Brief summary: Obesity Hypoventilation Syndrome(OHS) is a disease characterized by daytime hypercapnia and sleep-disordered breathing without other causes of hypoventilation in individuals with a body mass index above 30 kg/m2. Sources state that obesity is at the basis of the metabolic changes seen in individuals with OHS. Obesity, together with cardiovascular system complications, lung volumes, work of breathing and sleep quality, creating the basis for respiratory problems. In addition, sedentary lifestyle habits, which are common in obese individuals, cause negative effects on exercise capacity and peripheral muscle strength. It has been shown in the literature that decreased exercise capacity due to obesity strongly interacts with the risk of all-cause mortality. As a result of obesity and all this negative picture, impaired emotional state and decreased quality of life are observed in individuals. Numerous studies have shown that obese individuals generally have a low level of physical activity, there is a decrease in peripheral muscle strength, obese individuals are at risk for sleep-related respiratory problems and health-related quality of life is often negatively affected in obese individuals. With these studies, the effects of obesity on individuals have been evaluated with objective evaluation methods. However, the same cannot be said for OHS. It is not clear how exercise capacity, peripheral muscle strength and quality of life parameters, which are known to be negatively affected by obesity, are affected in individuals with OHS. Based on this point, this study aims to investigate whether OHS has an additional effect on exercise capacity, peripheral muscle strength and quality of life in addition to obesity.

Detailed description: Patients with Obesity Hypoventilation Syndrome who are followed up in Istanbul University, Istanbul Faculty of Medicine, Department of Chest Diseases and obese individuals who are followed up in Istanbul University, Istanbul Faculty of Medicine, Department of Internal Diseases and who are in the low risk group according to stop bang evaluation will be included in the study. The data of individuals diagnosed with OHS and obese individuals will be compared. The study will be conducted in accordance with the Declaration of Helsinki and consent form will be obtained from the patients participating in the study, indicating that they are willing to participate in the study. Before starting the study, the purpose of the study will be explained to the participants and all information about the study will be provided. The subjects who agree to participate in the study will be invited to Istanbul University Faculty of Medicine, Department of Chest Diseases on certain days. Demographic information of the subjects will be recorded. Body composition, presence of comorbidities, exercise capacity, peripheral muscle strength, sleep quality and quality of life will then be assessed. The primary aim of the study was to investigate whether Obesity Hypoventilation Syndrome has an additional effect on exercise capacity, peripheral muscle strength and quality of life compared to obesity.

Eligibility criteria: Inclusion Criteria:

* 30 \< body mass index \< 45 kg/m2
* Patients who have been diagnosed with Obesity Hypoventilation Syndrome
* Obese subjects with low risk of obstructive sleep apnea (STOP-BANG score \< 3)

Exclusion Criteria:

* Patients with uncontrollable respiratory and comorbid diseases
* Patient who have been an orthopedic, neurological, cardiac, or metabolic condition that may prevent participation and continuation of the exercise program throughout the study

Primary outcomes:
measure: Six Minute Walk Test-Distance
timeFrame: 1 day
measure: Six Minute Walk Test-Oxygen Saturation
timeFrame: 1 day
measure: Six Minute Walk Test-Heart Rate
timeFrame: 1 day
measure: Six Minute Walk Test-Blood Pressure
timeFrame: 1 day
measure: Six Minute Walk Test-Dyspnea
timeFrame: 1 day
measure: Six Minute Walk Test-Leg Fatigue
timeFrame: 1 day
measure: Nottingham Health Profile
timeFrame: 1 day
measure: Muscle Strength - Dynamometer
timeFrame: 1 day
Secondary outcomes:
measure: Body Fat Percentage
timeFrame: 1 day
measure: Body Fluid Percentage
timeFrame: 1 day
measure: Muscle Mass
timeFrame: 1 day
measure: Body Mass Index
timeFrame: 1 day
measure: Anthropometric Measurements-Neck
timeFrame: 1 day
measure: Anthropometric Measurements-Waist
timeFrame: 1 day
measure: Anthropometric Measurements-Abdomen
timeFrame: 1 day
measure: Anthropometric Measurements-Hip
timeFrame: 1 day
measure: The Waist-Hip ratio
timeFrame: 1 day
measure: Modified Charlson Comorbidity Index
timeFrame: 1 day
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Goksen KURAN ASLAN, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Ece ACIKBAS, PT,MSc
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Ozge ERTAN HARPUTLU, PT,MSc
role: STUDY_CHAIR
affiliation: Istanbul University
name: Esen KIYAN, Prof
role: STUDY_CHAIR
affiliation: Istanbul University
name: Bedia Fulya CALIKOGLU, Lect. PhD
role: STUDY_CHAIR
References: