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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06142513
• Other study ID #: 2023-1/GAslan
• Status: Not yet recruiting
• Start date: April 10, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2024
• Source: Istanbul University
• Contact: Ece ACIKBAS, PT,MSc
• Phone: +905545389767
• Email: ece.acikbas[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Primary	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.	1 day
Primary	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.	1 day
Primary	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.	1 day
Primary	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.	1 day
Primary	Six Minute Walk Test-Leg Fatigue	6 dakika yürüme testi, kisinin 30 metrelik bir koridorda 6 dakika boyunca mümkün olabilecek en hizli sekilde yürümesi ile gerçeklestirilmektedir. Test öncesi ve sonrasinda Borg skalasina göre 0-10 arasinda puanlandirilarak kaydedilir.	1 day
Primary	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.	1 day
Primary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	Anthropometric Measurements-Neck	With the help of a tape measure, neck circumference will be measured in cm.	1 day
Secondary	Anthropometric Measurements-Waist	With the help of a tape measure, waist circumference will be measured in cm.	1 day
Secondary	Anthropometric Measurements-Abdomen	With the help of a tape measure, abdomen circumference will be measured in cm.	1 day
Secondary	Anthropometric Measurements-Hip	With the help of a tape measure, hip circumference will be measured in cm.	1 day
Secondary	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.	1 day
Secondary	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).	1 day
Secondary	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.	1 day