The Effect of Obesity Hypoventilation Syndrome on Exercise Capacity, Peripheral Muscle Strength, and Quality of Life in Obese Individuals

NCT ID: NCT06142513

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-10

Study Completion Date

2025-03-01

Brief Summary

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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

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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.

Conditions

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Obesity Hypoventilation Syndrome Obesity Hypoventilation Respiration Disorders Sleep Disorder; Breathing-Related

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Grup I

Subjects with obesity hypoventilation syndrome (30 \< body mass index \< 45 kg/m2)

Assessment

Intervention Type OTHER

Between December 2023 and June 204, 46 volunteer participants aged 18 years and older who met the inclusion criteria and were followed up at Istanbul University, Istanbul Faculty of Medicine, Department of Chest Diseases and Istanbul Faculty of Medicine, Department of Internal Medicine were included in the project. Participants' body composition, comorbidities, exercise capacity, peripheral muscle strength, sleep quality and quality of life were assessed.

Grup II

Age and sex-matched obese subjects (30 \< body mass index \< 45 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3)

Assessment

Intervention Type OTHER

Between December 2023 and June 204, 46 volunteer participants aged 18 years and older who met the inclusion criteria and were followed up at Istanbul University, Istanbul Faculty of Medicine, Department of Chest Diseases and Istanbul Faculty of Medicine, Department of Internal Medicine were included in the project. Participants' body composition, comorbidities, exercise capacity, peripheral muscle strength, sleep quality and quality of life were assessed.

Interventions

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Assessment

Between December 2023 and June 204, 46 volunteer participants aged 18 years and older who met the inclusion criteria and were followed up at Istanbul University, Istanbul Faculty of Medicine, Department of Chest Diseases and Istanbul Faculty of Medicine, Department of Internal Medicine were included in the project. Participants' body composition, comorbidities, exercise capacity, peripheral muscle strength, sleep quality and quality of life were assessed.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Goksen Kuran Aslan

Associated Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Goksen KURAN ASLAN, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Ece ACIKBAS, PT,MSc

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Ozge ERTAN HARPUTLU, PT,MSc

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Esen KIYAN, Prof

Role: STUDY_CHAIR

Istanbul University

Bedia Fulya CALIKOGLU, Lect. PhD

Role: STUDY_CHAIR

Istanbul University

Locations

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Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023-1/GAslan

Identifier Type: -

Identifier Source: org_study_id

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