Clinical trial NCT05398068: Effects of Exercise Training on Exercise Capacity and Sleep Quality in Patients With Obesity Hypoventilation Syndrome
Official title: Effects of Exercise Training on Exercise Capacity and Sleep Quality in Patients With Obesity Hypoventilation Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity Hypoventilation Syndrome (OHS)
Hypoventilation
Obesity
Respiration Disorders
Sleep Disorder
Keywords: Obesity
Exercise Capacity
Physical Activity
Quality of Life
Hand Grip Strength
Anxiety
Depression
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2022-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Six Minutes Walk Test
timeFrame: 10 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 10 weeks
Secondary outcomes:
measure: Nottingham Health Profile
timeFrame: 10 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 10 weeks
measure: Muscle Strength - Dynamometer
timeFrame: 10 weeks
measure: Body Fat Percentage
timeFrame: 10 weeks
measure: Body Fluid Percentage
timeFrame: 10 weeks
measure: Muscle Mass
timeFrame: 10 weeks
measure: Bone Mass
timeFrame: 10 weeks
measure: Body Mass Index
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: