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Clinical Trials/NCT05398068
NCT05398068
Completed
Not Applicable

Effects of Exercise Training on Exercise Capacity and Sleep Quality in Patients With Obesity Hypoventilation Syndrome

Istanbul University1 site in 1 country40 target enrollmentJune 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity Hypoventilation Syndrome (OHS)
Sponsor
Istanbul University
Enrollment
40
Locations
1
Primary Endpoint
Six Minutes Walk Test
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

Obesity Hypoventilation Syndrome is defined as a combination of obesity (BMI ≥ 30 kg/m2) and daytime hypercapnia in arterial blood gas analysis (PaCO2 > 45 mmHg) without other pathologies that cause hypoventilation. Symptoms seen in individuals diagnosed with OHS are stated as a feeling of suffocation due to apnea, loud snoring, morning headache and excessive daytime sleepiness. Respiratory mechanics, respiratory muscle performance, pulmonary gas exchange, lung functions and exercise capacity parameters are adversely affected in patients. Early treatment is important so that these negative changes do not lead to worse outcomes. Weight control, bariatric surgery, pharmacological treatment and non-invasive mechanical ventilation (NIMV) are included in the treatment program of OHS patients. The effects of exercise on the treatment program of OHS patients are unknown. Considering all the studies in the literature, the primary purpose of this study is to evaluate aerobic and strength training on exercise capacity and sleep quality in patients with hypoventilation syndrome. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength, emotional state, body composition and quality of life parameters. In addition, the researchers believe that this study will form the basis for further scientific studies on OHS and exercise and will make an important contribution to the literature.

Detailed Description

Patients with Obesity Hypoventilation Syndrome followed for at least 1 month in the Department of Chest Diseases, Faculty of Medicine, Istanbul University will be included in the study. The patients will be divided into two groups using the computer-assisted randomization program as the study and control groups. 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 given. After 10 weeks of exercise training, patients will be evaluated with, Six-Minute Walking Test, pittsburgh sleep quality index, Body Composition, Nottingham Health Profile, Hospital Anxiety and Depression Scale and Muscle strength. The primary aim is to examine the effects of evaluate aerobic and strengthening training on exercise capacity and sleep quality in patients with hypoventilation syndrome. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength, emotional state, body composition and quality of life parameters.

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
June 7, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Goksen Kuran Aslan

Associated Proffesor

Istanbul University

Eligibility Criteria

Inclusion Criteria

  • \>18 years old
  • Patients who have been diagnosed with Obesity Hypoventilation Syndrome

Exclusion Criteria

  • Patients who participate in any other diet program
  • Patients who are incompatible with a diet program or exercise program
  • 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

Outcomes

Primary Outcomes

Six Minutes Walk Test

Time Frame: 10 weeks

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. The distance that normal individuals should take in this period is 400-700 meters. In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing. Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.

Pittsburgh Sleep Quality Index

Time Frame: 10 weeks

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. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.

Epworth Sleepiness Scale

Time Frame: 10 weeks

The Epworth Sleepiness Scale is designed to assess the tendency to fall asleep during the day and the frequency of such episodes. It consists of eight different situations in which participants rate their likelihood of dozing off. Each item is scored on a 4-point scale ranging from 0 to 3, resulting in a total score between 0 and 24. A total score greater than 10 indicates excessive daytime sleepiness.

Secondary Outcomes

  • Nottingham Health Profile(10 weeks)
  • Hospital Anxiety and Depression Scale(10 weeks)
  • Muscle Strength - Dynamometer(10 weeks)
  • Body Fat Percentage(10 weeks)
  • Body Fluid Percentage(10 weeks)
  • Muscle Mass(10 weeks)
  • Body Mass Index(10 weeks)
  • Handgrip Strength(10 weeks)
  • Physical Activity Level(10 weeks)
  • Neck Circumference(10 weeks)
  • Waist circumference(10 weeks)
  • Hip circumference(10 weeks)

Study Sites (1)

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