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

NCT05398068 | Completed

• 1 other identifier: 2022/30
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Six Minutes Walk Test

  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.

  10 weeks

• 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. 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.

  10 weeks

• Epworth Sleepiness Scale

  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.

  10 weeks

Secondary Outcomes (12)

• 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

Study Arms (2)

Training (Exercises and Diet) Group

EXPERIMENTAL

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.

Other: Exercises and Diet

Control (Diet) Group

ACTIVE COMPARATOR

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

Other: Diet

Interventions

Exercises and Diet OTHER

Non-Invasive Ventilation (NIV) will be included in the treatment program of all patients participating in the study. For the Mediterranean diet protocol planned in training groups; each patient will be evaluated by a dietitian at the beginning of the study and individual diet programs will be planned. A 10-week exercise training will be planned for the training group. Aerobic exercise sessions will be planned as a 5-minute warm-up - 20-minute bicycle ergometer - 5-minute cooling-down program. The intensity of exercise will be planned to be of medium intensity according to the heart rate reserve (40-50%). According to the Modified Borg Scale, walking will be given 3 days a week at a intensity of 4-6, also as a home exercise. Strengthening exercises will be planned with reference to 10 RM (repetition maximum) with theraband for large muscle groups (10 repetitions-3 sets).

Training (Exercises and Diet) Group

Diet OTHER

Non-Invasive Ventilation (NIV) will be included in the treatment program of all patients participating in the study. A regular diet program will be planned for 10 weeks for the control group. . For the Mediterranean diet protocol planned in control groups; each patient will be evaluated by a dietitian at the beginning of the study and individual diet programs will be planned. After that, after 1 week, patients will be re-evaluated for compliance by a dietitian. And than, each patient included in the study will be evaluated for 2 weeks during the treatment period.

Control (Diet) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Hypoventilation; Obesity; Respiration Disorders; Sleep Wake Disorders; Motor Activity; Anxiety Disorders; Depression

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiratory Tract Diseases; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight; Neurologic Manifestations; Mental Disorders; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffesor

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: May 31, 2022
• Study Start: June 15, 2022
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)