Obesity Hypoventilation SyndromeNCT06142513
The Effect of Obesity Hypoventilation Syndrome on Exercise Capacity, Peripheral Muscle Strength, and Quality of Life in Obese Individuals
An observational study of Obesity Hypoventilation Syndrome and Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome, Obesity, Hypoventilation
- What is being tested?
- Assessment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34320
About this study
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.
Read the 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.
- Conditions
- Obesity Hypoventilation Syndrome, Obesity, Hypoventilation, Respiration Disorders, Sleep Disorder; Breathing-Related
- Being tested
- Assessment
- Keywords
- Obesity, Obesity Hypoventilation Syndrome, Exercise Capacity, Quality of Life, Peripheral Muscle Strength
- Medical subject headings
- Obesity Hypoventilation Syndrome, Obesity, Hypoventilation, Respiration Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Grup I | Subjects with obesity hypoventilation syndrome (30 < body mass index < 45 kg/m2) Receives: Other: Assessment | |
| 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) Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk Test-Distance
The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes.
Measured: 1 day
Six Minute Walk Test-Oxygen Saturation
The 6-minute walk test is performed by walking as fast as possible for 6 minutes in a 30-meter corridor. Oxygen saturation measured by pulse oximetry before and after the test is recorded as a percentage.
Measured: 1 day
Six Minute Walk Test-Heart Rate
The 6-minute walk test is performed by walking as fast as possible for 6 minutes in a 30-meter corridor. The heart rate measured by pulse oximetry is recorded before and after the test.
Measured: 1 day
Six Minute Walk Test-Blood Pressure
The 6-minute walk test is performed by walking as fast as possible for 6 minutes in a 30-meter corridor. Before and after the test, blood pressure is measured with a sphygmomanometer and recorded in mmHg.
Measured: 1 day
Six Minute Walk Test-Dyspnea
The 6-minute walk test is performed by walking as fast as possible for 6 minutes in a 30-meter corridor. Before and after the test, a score of 0-10 is recorded according to the Borg scale.
Measured: 1 day
Six Minute Walk Test-Leg Fatigue
6 dakika yürüme testi, kişinin 30 metrelik bir koridorda 6 dakika boyunca mümkün olabilecek en hızlı şekilde yürümesi ile gerçekleştirilmektedir. Test öncesi ve sonrasında Borg skalasına göre 0-10 arasında puanlandırılarak kaydedilir.
Measured: 1 day
Nottingham Health Profile
The Nottingham Health Profile (NHP) is a general patient reported outcome measure which seeks to measure subjective health status. It is a questionnaire designed to measure a patient's view of their own health status, in a number of areas. The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays. The second part of the NHP is optional and can be omitted without ruining the test results.
Measured: 1 day
Muscle Strength - Dynamometer
A digital dynamometer will be used to evaluate muscle strength. Muscle strength will be evaluated in the following muscles, each measurement will be made three times and the average will be taken.
Measured: 1 day
Secondary outcomes (11)
Body Fat Percentage
The body fat percentage of a patient is the total mass of fat divided by total body mass, multiplied by 100; body fat includes essential body fat and storage body fat. The body fat percentage of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. And results will be recorded in percent.
Measured: 1 day
Body Fluid Percentage
Body fluids, bodily fluids, or biofluids are liquids within the human body. The body fluid percentage of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. And results will be recorded in percent.
Measured: 1 day
Muscle Mass
Muscle mass refers to the amount of soft muscle tissue in the body. The muscle mass of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. And results will be recorded in kg.
Measured: 1 day
Body Mass Index
Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
Measured: 1 day
Anthropometric Measurements-Neck
With the help of a tape measure, neck circumference will be measured in cm.
Measured: 1 day
Anthropometric Measurements-Waist
With the help of a tape measure, waist circumference will be measured in cm.
Measured: 1 day
Anthropometric Measurements-Abdomen
With the help of a tape measure, abdomen circumference will be measured in cm.
Measured: 1 day
Anthropometric Measurements-Hip
With the help of a tape measure, hip circumference will be measured in cm.
Measured: 1 day
The Waist-Hip ratio
With the help of a tape measure, waist and hip circumference will be measured in cm. Depending on the circumference measurements, waist and hip circumference is calculated as waist to hip ratio.
Measured: 1 day
Modified Charlson Comorbidity Index
The Charlson Comorbidity Index (CCI) was initially developed to predict the survival time of individuals diagnosed with cancer by assigning weights to specific diseases. Today, it is used as a guide for individuals with multiple comorbidities. In this index, diseases are scored based on their morbidity and mortality. The total score is calculated by summing the equivalent scores of diseases. Comorbidity classification is categorized as low (score ≤ 3), moderate (score 4 and 5), high (score 6 and 7), and very high comorbidity (score ≥ 8).
Measured: 1 day
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start10 Apr 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Goksen Kuran Aslan, Istanbul University
- Investigators
- Goksen KURAN ASLAN, Assoc. Prof., Principal investigator, Istanbul University - CerrahpasaEce ACIKBAS, PT,MSc, Study chair, Istanbul University - CerrahpasaOzge ERTAN HARPUTLU, PT,MSc, Study chair, Istanbul University - CerrahpasaEsen KIYAN, Prof, Study chair, Istanbul UniversityBedia Fulya CALIKOGLU, Lect. PhD, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142513
- Sponsor's protocol ID
- 2023-1/GAslan
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Obesity Hypoventilation Syndrome on Exercise Capacity, Peripheral Muscle Strength, and Quality of Life in Obese Individuals
- ClinicalTrials.gov ID
- NCT06142513
- Acronym / sponsor ID
- 2023-1/GAslan
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grup I | – | Other: AssessmentSubjects with obesity hypoventilation syndrome (30 < body mass index < 45 kg/m2) |
| Grup II | – | Other: AssessmentAge and sex-matched obese subjects (30 < body mass index < 45 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score < 3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentBetween 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. | Other | Grup I, Grup II |
Primary outcome
Six Minute Walk Test-Distance
Time frame: 1 day
The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes.
Six Minute Walk Test-Oxygen Saturation
Time frame: 1 day
The 6-minute walk test is performed by walking as fast as possible for 6 minutes in a 30-meter corridor. Oxygen saturation measured by pulse oximetry before and after the test is recorded as a percentage.
Six Minute Walk Test-Heart Rate
Time frame: 1 day
The 6-minute walk test is performed by walking as fast as possible for 6 minutes in a 30-meter corridor. The heart rate measured by pulse oximetry is recorded before and after the test.
Six Minute Walk Test-Blood Pressure
Time frame: 1 day
The 6-minute walk test is performed by walking as fast as possible for 6 minutes in a 30-meter corridor. Before and after the test, blood pressure is measured with a sphygmomanometer and recorded in mmHg.
Six Minute Walk Test-Dyspnea
Time frame: 1 day
The 6-minute walk test is performed by walking as fast as possible for 6 minutes in a 30-meter corridor. Before and after the test, a score of 0-10 is recorded according to the Borg scale.
Six Minute Walk Test-Leg Fatigue
Time frame: 1 day
6 dakika yürüme testi, kişinin 30 metrelik bir koridorda 6 dakika boyunca mümkün olabilecek en hızlı şekilde yürümesi ile gerçekleştirilmektedir. Test öncesi ve sonrasında Borg skalasına göre 0-10 arasında puanlandırılarak kaydedilir.
Nottingham Health Profile
Time frame: 1 day
The Nottingham Health Profile (NHP) is a general patient reported outcome measure which seeks to measure subjective health status. It is a questionnaire designed to measure a patient's view of their own health status, in a number of areas. The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays. The second part of the NHP is optional and can be omitted without ruining the test results.
Muscle Strength - Dynamometer
Time frame: 1 day
A digital dynamometer will be used to evaluate muscle strength. Muscle strength will be evaluated in the following muscles, each measurement will be made three times and the average will be taken.
11 secondary outcomes
Body Fat Percentage
Time frame: 1 day
Body Fluid Percentage
Time frame: 1 day
Muscle Mass
Time frame: 1 day
Body Mass Index
Time frame: 1 day
Anthropometric Measurements-Neck
Time frame: 1 day
Anthropometric Measurements-Waist
Time frame: 1 day
Anthropometric Measurements-Abdomen
Time frame: 1 day
Anthropometric Measurements-Hip
Time frame: 1 day
The Waist-Hip ratio
Time frame: 1 day
Modified Charlson Comorbidity Index
Time frame: 1 day
Pittsburgh Sleep Quality Index
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goksen KURAN ASLAN, Assoc. Prof. principal investigator
Istanbul University - Cerrahpasa
Ece ACIKBAS, PT,MSc study chair
Istanbul University - Cerrahpasa
Ozge ERTAN HARPUTLU, PT,MSc study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity Hypoventilation Syndrome and Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minute Walk Test-Distance (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.