Obesity Hypoventilation Syndrome (OHS)NCT06766110
Evaluation of Upper Extremity Functions in Obesity Hypoventilation Syndrome Patients
An observational study of Obesity Hypoventilation Syndrome (OHS), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Obesity Hypoventilation Syndrome (OHS) is a disease characterized by daytime hypercapnia and sleep-related respiratory disturbances in individuals with a body mass index (BMI) greater than 30 kg/m², without any other condition that could lead to hypoventilation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome (OHS)
- What is being tested?
- Assessment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2025to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Obesity Hypoventilation Syndrome who are followed up at the Department of Chest Diseases of Istanbul University Istanbul Faculty of Medicine will be included in the study.
Who may be able to join
- Individuals between the ages of 18-65
- Individuals diagnosed with OHS by a Chest Disease Specialist
Who cannot join
- Individuals with neurological or orthopedic problems that prevent them from performing the tests or understanding the scales applied within the scope of the study
- Additional pulmonary disease
- Uncontrolled cardiovascular disease
- Presence of uncontrolled diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Upper Extremity Functions in Patients with Obesity Hypoventilation Syndrome
Obesity Hypoventilation Syndrome (OHS) is a disease characterized by daytime hypercapnia and sleep-related respiratory disturbances in individuals with a body mass index (BMI) greater than 30 kg/m², without any other condition that could lead to hypoventilation. Although various mechanisms play a role in the pathogenesis of OHS, the most significant one is the altered respiratory system mechanics due to obesity. Obesity also leads to a decrease in peripheral muscle strength and exercise capacity. It has been reported that in obese individuals, not only general body movements and lower extremities but also upper extremity movements are negatively affected. Specifically, it has been observed that during activities against gravity, movement speed is low while the duration of movement is high. In OHS patients, daily living activities, physical activity, and exercise capacity are also negatively impacted. Supported or unsupported arm movements are of great importance in performing daily living activities. The muscles activated during both simple arm lifting and combined movements also function as accessory respiratory muscles. In individuals with cardiopulmonary diseases, an increase in the respiratory workload, especially during unsupported arm movements, has been observed. It is thought that in OHS patients, both the effects of obesity and the respiratory system may limit upper extremity functions. However, no studies have evaluated upper extremity functions in these individuals. Therefore, the aim of investigators study is to evaluate upper extremity functions in OHS patients.
Read the detailed description
The study will include patients diagnosed with Obesity Hypoventilation Syndrome, who are followed at the Department of Chest Diseases, Istanbul University Faculty of Medicine. The study will be conducted in accordance with the Helsinki Declaration, and an informed consent form will be obtained from the participants who are willing to take part in the study. Before the study begins, the participants will be informed about the purpose of the study and provided with all relevant details. Participants who agree to participate will be invited to the Chest Diseases Department of Istanbul University Faculty of Medicine. Demographic information of the participants will be recorded, followed by the evaluation of body composition, upper extremity functional exercise capacity, grip strength, and activities of daily living. The main aim of the study is to comprehensively investigate the upper extremity functions in patients with OHS.
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Being tested
- Assessment
- Keywords
- Obesity Hypoventilation Syndrome (OHS), upper extremity function, hand grip strength, activities of daily living
- Medical subject headings
- Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
31 volunteer participants who were followed up at the Department of Chest Diseases, Istanbul University, Istanbul Faculty of Medicine and met the inclusion criteria were included in the study. Participants' body composition, upper extremity functional exercise capacity, grip strength, and activities of daily living were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Obesity Hypoventilation Syndrome | Not described Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Pegboard and Ring Test - Upper Extremity Functional Exercise Capacity
For the test, a perforated wooden board and bars, adjustable according to shoulder levels, are used. The participant sits in front of the board, which has a total of four sticks: two placed at shoulder level and shoulder width, and two placed 20 cm above this level. Ten rings are placed on the lower sticks. The participant is instructed to use both hands simultaneously to move the rings from the lower stick to the upper one and return them to the lower stick once completed. They are asked to perform this task as quickly as possible for 6 minutes. The number of rings is recorded and heart rate, blood pressure, oxygen saturation, fatigue, and dyspnea are measured before and after the test.
Measured: 1 day
Milliken Activities of Daily Living Scale
This scale is a self-reported assessment that evaluates upper extremity dysfunctions and shows limitations in ADL. It consists of 6 sections: meal preparation and eating (8 items), personal hygiene (9 items), dressing (8 items), object manipulation (9 items), house cleaning (7 items), and other activities (6 items), totaling 47 items. For each item, both ability and requirement levels are scored; the ability level uses a 1-5 scale, and the requirement level uses a 1-3 scale.
Measured: 1 day
Grip Strength
Grip strength is measured with a Jamar hand dynamometer recommended by the American Hand Therapists Association. Measurements are made with the participant in shoulder adduction, elbow 90° flexion, forearm neutral, and wrist 0-30° extension. The participant is asked to squeeze the dynamometer with maximum force and hold for 3 seconds. Measurements are repeated 3 times on the dominant and non-dominant hands, and the results are recorded in kg.
Measured: 1 day
The Glittre Activities of Daily Living Test
The test starts from a seated position on a 10-meter surface. After walking 5 meters, the participant climbs a two-step ladder, walks to the shelves, and moves three 1 kg objects from the top shelf to the middle and bottom shelves, then returns them to the middle and top shelves. The participant then turns around, climbs the stairs, and sits back down. This completes one full round, and a total of 5 rounds are performed. The participant is asked to complete the rounds as quickly as possible. Women carry a 2.5 kg backpack, and men carry a 5 kg backpack. The completion time is recorded, and heart rate, blood pressure, oxygen saturation, fatigue, and dyspnea are measured before and after the test.
Measured: 1 day
Secondary outcomes (9)
Body Mass Index
Body mass index (BMI) is calculated by dividing body weight in kilograms (kg) by the square of height in meters (m). BMI is calculated from the formula body weight/height² (kg/m²).
Measured: 1 day
Anthropometric Measurements - Waist Circumference
Waist circumference is measured in cm using a standard non-elastic tape measure from the midpoint between the subcostal region and the iliac crest after full expiration.
Measured: 1 day
Anthropometric Measurements - Hip Circumference
Hip circumference is measured from the widest part of the hip, with the tape measure parallel to the floor.
Measured: 1 day
Anthropometric Measurements - Neck Circumference
Neck circumference is measured horizontally from the lower border of the laryngeal prominence with the head in an upright position.
Measured: 1 day
Anthropometric Measurements - Arm Circumference
Arm circumference is measured from the midpoint of the distance between the acromion and the olecranon, which is the most swollen part of the muscle.
Measured: 1 day
The Waist-Hip Ratio
Waist and hip circumference will be measured in cm with the help of a tape measure. It is calculated by dividing the waist circumference by the hip circumference.
Measured: 1 day
Body Fluid Percentage
Participants body fluid percentage will be measured using the 'Tanita BC-545N Body Analysis Scale' with the bioelectrical impedance analysis method.
Measured: 1 day
Body Fat Percentage
Participants body fat percentages will be evaluated using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique.
Measured: 1 day
Muscle Mass
Participants' muscle mass will be assessed using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. The results will be recorded in kg.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Yıldız, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766110
- Sponsor's protocol ID
- IUC-FTR-NYildiz-01
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Upper Extremity Functions in Patients with Obesity Hypoventilation Syndrome
- ClinicalTrials.gov ID
- NCT06766110
- Acronym / sponsor ID
- IUC-FTR-NYildiz-01
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Keywords
- Obesity Hypoventilation Syndrome (OHS), upper extremity function, hand grip strength, activities of daily living
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity Hypoventilation Syndrome (OHS) is a disease characterized by daytime hypercapnia and sleep-related respiratory disturbances in individuals with a body mass index (BMI) greater than 30 kg/m², without any other condition that could lead to hypoventilation. Although various mechanisms play a role in the pathogenesis of OHS, the most significant one is the altered respiratory system mechanics due to obesity. Obesity also leads to a decrease in peripheral muscle strength and exercise capacity. It has been reported that in obese individuals, not only general body movements and lower extremities but also upper extremity movements are negatively affected. Specifically, it has been observed that during activities against gravity, movement speed is low while the duration of movement is high. In OHS patients, daily living activities, physical activity, and exercise capacity are also negatively impacted. Supported or unsupported arm movements are of great importance in performing daily living activities. The muscles activated during both simple arm lifting and combined movements also function as accessory respiratory muscles. In individuals with cardiopulmonary diseases, an increase in the respiratory workload, especially during unsupported arm movements, has been observed. It is thought that in OHS patients, both the effects of obesity and the respiratory system may limit upper extremity functions. However, no studies have evaluated upper extremity functions in these individuals. Therefore, the aim of investigators study is to evaluate upper extremity functions in OHS patients.
Detailed description
The study will include patients diagnosed with Obesity Hypoventilation Syndrome, who are followed at the Department of Chest Diseases, Istanbul University Faculty of Medicine. The study will be conducted in accordance with the Helsinki Declaration, and an informed consent form will be obtained from the participants who are willing to take part in the study. Before the study begins, the participants will be informed about the purpose of the study and provided with all relevant details. Participants who agree to participate will be invited to the Chest Diseases Department of Istanbul University Faculty of Medicine. Demographic information of the participants will be recorded, followed by the evaluation of body composition, upper extremity functional exercise capacity, grip strength, and activities of daily living. The main aim of the study is to comprehensively investigate the upper extremity functions in patients with OHS.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Obesity Hypoventilation Syndrome | – | Other: Assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Obesity Hypoventilation Syndrome who are followed up at the Department of Chest Diseases of Istanbul University Istanbul Faculty of Medicine will be included in the study.
Key inclusion criteria (2 listed)
- Individuals between the ages of 18-65
- Individuals diagnosed with OHS by a Chest Disease Specialist
Key exclusion criteria (4 listed)
- Individuals with neurological or orthopedic problems that prevent them from performing the tests or understanding the scales applied within the scope of the study
- Additional pulmonary disease
- Uncontrolled cardiovascular disease
- Presence of uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment31 volunteer participants who were followed up at the Department of Chest Diseases, Istanbul University, Istanbul Faculty of Medicine and met the inclusion criteria were included in the study. Participants' body composition, upper extremity functional exercise capacity, grip strength, and activities of daily living were evaluated. | Other | Subjects with Obesity Hypoventilation Syndrome |
Primary outcome
6-Minute Pegboard and Ring Test - Upper Extremity Functional Exercise Capacity
Time frame: 1 day
For the test, a perforated wooden board and bars, adjustable according to shoulder levels, are used. The participant sits in front of the board, which has a total of four sticks: two placed at shoulder level and shoulder width, and two placed 20 cm above this level. Ten rings are placed on the lower sticks. The participant is instructed to use both hands simultaneously to move the rings from the lower stick to the upper one and return them to the lower stick once completed. They are asked to perform this task as quickly as possible for 6 minutes. The number of rings is recorded and heart rate, blood pressure, oxygen saturation, fatigue, and dyspnea are measured before and after the test.
Milliken Activities of Daily Living Scale
Time frame: 1 day
This scale is a self-reported assessment that evaluates upper extremity dysfunctions and shows limitations in ADL. It consists of 6 sections: meal preparation and eating (8 items), personal hygiene (9 items), dressing (8 items), object manipulation (9 items), house cleaning (7 items), and other activities (6 items), totaling 47 items. For each item, both ability and requirement levels are scored; the ability level uses a 1-5 scale, and the requirement level uses a 1-3 scale.
Grip Strength
Time frame: 1 day
Grip strength is measured with a Jamar hand dynamometer recommended by the American Hand Therapists Association. Measurements are made with the participant in shoulder adduction, elbow 90° flexion, forearm neutral, and wrist 0-30° extension. The participant is asked to squeeze the dynamometer with maximum force and hold for 3 seconds. Measurements are repeated 3 times on the dominant and non-dominant hands, and the results are recorded in kg.
The Glittre Activities of Daily Living Test
Time frame: 1 day
The test starts from a seated position on a 10-meter surface. After walking 5 meters, the participant climbs a two-step ladder, walks to the shelves, and moves three 1 kg objects from the top shelf to the middle and bottom shelves, then returns them to the middle and top shelves. The participant then turns around, climbs the stairs, and sits back down. This completes one full round, and a total of 5 rounds are performed. The participant is asked to complete the rounds as quickly as possible. Women carry a 2.5 kg backpack, and men carry a 5 kg backpack. The completion time is recorded, and heart rate, blood pressure, oxygen saturation, fatigue, and dyspnea are measured before and after the test.
9 secondary outcomes
Body Mass Index
Time frame: 1 day
Anthropometric Measurements - Waist Circumference
Time frame: 1 day
Anthropometric Measurements - Hip Circumference
Time frame: 1 day
Anthropometric Measurements - Neck Circumference
Time frame: 1 day
Anthropometric Measurements - Arm Circumference
Time frame: 1 day
The Waist-Hip Ratio
Time frame: 1 day
Body Fluid Percentage
Time frame: 1 day
Body Fat Percentage
Time frame: 1 day
Muscle Mass
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity Hypoventilation Syndrome (OHS)
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Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea
Obstructive Sleep Apnea, Obesity (BMI>30)
RecruitingObservational study
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
Bronchial Asthma, Bronchiectasis
Not yet recruiting
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity Hypoventilation Syndrome (OHS), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilgün Yıldız (+905335068683, yildiznilgunn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Pegboard and Ring Test - Upper Extremity Functional Exercise Capacity (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.