- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06766110
Evaluation of Upper Extremity Functions in Obesity Hypoventilation Syndrome Patients
January 7, 2025 updated by: Nilgün Yıldız, Istanbul University - Cerrahpasa
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nilgün Yıldız
- Phone Number: +905335068683
- Email: yildiznilgunn@gmail.com
Study Locations
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Istanbul, Turkey
- Istanbul University-Cerrahpasa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Individuals between the ages of 18-65
- Individuals diagnosed with OHS by a Chest Disease Specialist
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Subjects with Obesity Hypoventilation Syndrome
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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1 day
|
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Milliken Activities of Daily Living Scale
Time Frame: 1 day
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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.
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1 day
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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.
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1 day
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The Glittre Activities of Daily Living Test
Time Frame: 1 day
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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.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: 1 day
|
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).
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1 day
|
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Anthropometric Measurements - Waist Circumference
Time Frame: 1 day
|
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.
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1 day
|
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Anthropometric Measurements - Hip Circumference
Time Frame: 1 day
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Hip circumference is measured from the widest part of the hip, with the tape measure parallel to the floor.
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1 day
|
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Anthropometric Measurements - Neck Circumference
Time Frame: 1 day
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Neck circumference is measured horizontally from the lower border of the laryngeal prominence with the head in an upright position.
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1 day
|
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Anthropometric Measurements - Arm Circumference
Time Frame: 1 day
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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.
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1 day
|
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The Waist-Hip Ratio
Time Frame: 1 day
|
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.
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1 day
|
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Body Fluid Percentage
Time Frame: 1 day
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Participants body fluid percentage will be measured using the 'Tanita BC-545N Body Analysis Scale' with the bioelectrical impedance analysis method.
|
1 day
|
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Body Fat Percentage
Time Frame: 1 day
|
Participants body fat percentages will be evaluated using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique.
|
1 day
|
|
Muscle Mass
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
January 3, 2025
First Submitted That Met QC Criteria
January 7, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 7, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pathologic Processes
- Nutrition Disorders
- Overnutrition
- Body Weight
- Respiratory Tract Diseases
- Disease
- Respiration Disorders
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Overweight
- Apnea
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Apnea Syndromes
- Respiratory Insufficiency
- Sleep Apnea, Obstructive
- Obesity
- Syndrome
- Hypoventilation
- Obesity Hypoventilation Syndrome
Other Study ID Numbers
- IUC-FTR-NYildiz-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity Hypoventilation Syndrome (OHS)
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