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

Istanbul University

Status: Enrolling

Conditions: Respiration Disorders; Hypoventilation; Sleep Disorder; Obesity Hypoventilation Syndrome (OHS); Obesity

Treatments: Other: Diet; Other: Exercises and Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05398068

2022/30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Training (Exercises and Diet) Group

Experimental group

Description:

Training (Exercises and Diet) Group; Patients will follow a regular diet program for 10 weeks. Aerobic exercises will be planned for patients 2 days a week under the supervision of a physiotherapist, and 3 days a week as home exercises. Strengthening exercises will be planned for patients 1 days a week under the supervision of a physiotherapist, and 2 days a week as home exercises.

Treatment:

Other: Exercises and Diet

Control (Diet) Group

Active Comparator group

Description:

Control (Diet) Group; Patients will follow a regular diet program for 10 weeks.

Treatment:

Other: Diet