The Effect of Obesity Hypoventilation Syndrome on Exercise Capacity, Peripheral Muscle Strength, and Quality of Life in Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Six Minute Walk Test-Distance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Six Minute Walk Test-Distance
时间窗: 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-Blood Pressure
时间窗: 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-Leg Fatigue
时间窗: 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
时间窗: 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
时间窗: 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.
Six Minute Walk Test-Oxygen Saturation
时间窗: 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
时间窗: 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-Dyspnea
时间窗: 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.
次要结局
- Body Fluid Percentage(1 day)
- Muscle Mass(1 day)
- Body Mass Index(1 day)
- Body Fat Percentage(1 day)
- Anthropometric Measurements-Waist(1 day)
- Modified Charlson Comorbidity Index(1 day)
- Anthropometric Measurements-Neck(1 day)
- Anthropometric Measurements-Abdomen(1 day)
- Anthropometric Measurements-Hip(1 day)
- The Waist-Hip ratio(1 day)
- Pittsburgh Sleep Quality Index(1 day)
研究者
Goksen Kuran Aslan
Associated Proffesor
Istanbul University