The Effect of Obesity Hypoventilation Syndrome on Exercise Capacity, Peripheral Muscle Strength, and Quality of Life in Obese Individuals

NCT06142513 | Completed DMC

• 1 other identifier: 2023-1/GAslan
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity Hypoventilation Syndrome; Obesity; Hypoventilation; Respiration Disorders; Sleep Disorder; Breathing-Related

Keywords

Obesity; Obesity Hypoventilation Syndrome; Exercise Capacity; Quality of Life; Peripheral Muscle Strength

Outcome Measures

Primary Outcomes (8)

• Six Minute Walk Test-Distance

  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.

  1 day

• Six Minute Walk Test-Oxygen Saturation

  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.

  1 day

• Six Minute Walk Test-Heart Rate

  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.

  1 day

• Six Minute Walk Test-Blood Pressure

  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.

  1 day

• Six Minute Walk Test-Dyspnea

  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.

  1 day

• Six Minute Walk Test-Leg Fatigue

  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.

  1 day

• Nottingham Health Profile

  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.

  1 day

• Muscle Strength - Dynamometer

  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.

  1 day

Secondary Outcomes (11)

• Body Fat Percentage

  1 day

• Body Fluid Percentage

  1 day

• Muscle Mass

  1 day

• Body Mass Index

  1 day

• Anthropometric Measurements-Neck

  1 day

Study Arms (2)

Grup I

Subjects with obesity hypoventilation syndrome (30 \< body mass index \< 45 kg/m2)

Other: Assessment

Grup II

Age and sex-matched obese subjects (30 \< body mass index \< 45 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3)

Other: Assessment

Interventions

Assessment OTHER

Between December 2023 and June 204, 46 volunteer participants aged 18 years and older who met the inclusion criteria and were followed up at Istanbul University, Istanbul Faculty of Medicine, Department of Chest Diseases and Istanbul Faculty of Medicine, Department of Internal Medicine were included in the project. Participants' body composition, comorbidities, exercise capacity, peripheral muscle strength, sleep quality and quality of life were assessed.

Grup I; Grup II

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• \< 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)

You may not qualify if:

• 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; Obesity; Hypoventilation; Respiration Disorders; Sleep Wake Disorders

Interventions

Restraint, Physical

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; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Neurologic Manifestations; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Goksen KURAN ASLAN, Assoc. Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Ece ACIKBAS, PT,MSc

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Ozge ERTAN HARPUTLU, PT,MSc

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Esen KIYAN, Prof

  Istanbul University

  STUDY CHAIR

• Bedia Fulya CALIKOGLU, Lect. PhD

  Istanbul University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffesor

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 21, 2023
• Study Start: April 10, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)