Obesity Hypoventilation Syndrome (OHS)NCT05398068
Effects of Exercise Training on Exercise Capacity and Sleep Quality in Patients With Obesity Hypoventilation Syndrome
A study testing Exercises and Diet and Diet in people with Obesity Hypoventilation Syndrome (OHS) and Hypoventilation, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome (OHS), Hypoventilation, Obesity
- What is being tested?
- Exercises and Diet and Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 7 Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- Patients who have been diagnosed with Obesity Hypoventilation Syndrome
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34320
About this study
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.
Read the 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.
- Conditions
- Obesity Hypoventilation Syndrome (OHS), Hypoventilation, Obesity, Respiration Disorders, Sleep Disorder
- Being tested
- Exercises and Diet, Diet
- Keywords
- Obesity, Exercise Capacity, Physical Activity, Quality of Life, Hand Grip Strength, Anxiety, Depression
- Medical subject headings
- Obesity Hypoventilation Syndrome, Hypoventilation, Obesity, Respiration Disorders, Sleep Wake Disorders, Motor Activity, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises and DietOther
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).
DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercises and Diet |
| Control (Diet) Group | Active comparator | Control (Diet) Group; Patients will follow a regular diet program for 10 weeks. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (12)
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.
Measured: 10 weeks
Hospital Anxiety and Depression Scale
7 items of the scale assess anxiety and 7 items assess depression. The answers, which are evaluated in a three-point Likert format, are scored between 0-3. When patients scored 0-10 for anxiety, patients were defined as no anxiety, 11 or more anxiety, and 0-7 points for depression as no depression, 8 or more depression.
Measured: 10 weeks
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.
Measured: 10 weeks
Body Fat Percentage
The body fat percentage of a patient is the total mass of fat divided by total body mass, multiplied by 100; body fat includes essential body fat and storage body fat. The body fat percentage of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. And results will be recorded in percent.
Measured: 10 weeks
Body Fluid Percentage
Body fluids, bodily fluids, or biofluids are liquids within the human body. The body fluid percentage of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. And results will be recorded in percent.
Measured: 10 weeks
Muscle Mass
Muscle mass refers to the amount of soft muscle tissue in the body. The muscle mass of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. And results will be recorded in kg.
Measured: 10 weeks
Body Mass Index
Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
Measured: 10 weeks
Handgrip Strength
Handgrip strength will be assessed using a Jamar Hydraulic Hand Dynamometer (USA). The dominant hand will be used as reference. Before each evaluation, the dynamometer will be calibrated. Participants will be seated in an upright position with the arm adducted, elbow flexed at 90°, forearm in neutral position, and the wrist positioned at approximately 30° extension and 5° ulnar deviation, supported on a surface. During each trial, participants will be instructed to squeeze the dynamometer with maximum effort for 5 seconds. Three consecutive measurements will be obtained, with 30-second rest intervals to minimize fatigue. The mean value of the three trials will be recorded in pounds (lb).
Measured: 10 weeks
Physical Activity Level
Physical activity level will be assessed using a pedometer (Hattrick PD-30, China). The device is a portable, cost-effective, and easily accessible motion-sensor tool that records various physical activity parameters, including step count, walking speed, calories expended, and distance walked. In this study, the pedometer will be used to record daily step count, calories burned, and walking distance. The device has the capacity for daily recordings only.
Measured: 10 weeks
Neck Circumference
Neck circumference will be measured with a non-elastic tape measure, recorded in centimeters (cm). Measurements will be performed while the participant is standing upright with weight evenly distributed on both feet. The measurement point will be taken just below the larynx.
Measured: 10 weeks
Waist circumference
Waist circumference will be measured with a non-elastic tape measure, recorded in centimeters (cm). Measurements will be performed while the participant is standing upright with weight evenly distributed on both feet. The measurement point will be the midpoint between the lower margin of the last rib and the top of the iliac crest.
Measured: 10 weeks
Hip circumference
Hip circumference will be measured with a non-elastic tape measure, recorded in centimeters (cm). Measurements will be performed while the participant is standing upright with weight evenly distributed on both feet. The measurement point will be taken at the level of the greater trochanter of the femur.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Jun 2022
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation Syndrome (OHS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Goksen Kuran Aslan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398068
- Sponsor's protocol ID
- 2022/30
- Status last verified
- Aug 2025
- First submitted
- 22 May 2022
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No