ClinicalTrials.gg
Not yet recruitingNCT06766110Updated Jan 9, 2025

Evaluation of Upper Extremity Functions in Obesity Hypoventilation Syndrome Patients

An observational study in Obesity Hypoventilation Syndrome (OHS), sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by Istanbul University - Cerrahpasa · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
31
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity Hypoventilation Syndrome (OHS)

Keywords

  • Obesity Hypoventilation Syndrome (OHS)
  • upper extremity function
  • hand grip strength
  • activities of daily living
03

In context

Obesity Hypoventilation Syndrome

73 studies on the registry are indexed under Obesity Hypoventilation Syndrome; 10 are open to participants now.

This study's planned enrollment of 31 is below the median of 50 across 25 observational studies indexed under Obesity Hypoventilation Syndrome.

Browse Obesity Hypoventilation Syndrome studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals between the ages of 18-65
  • Individuals diagnosed with OHS by a Chest Disease Specialist

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
31 participants (estimated)
Patient registry
No

Groups and cohorts

  • Subjects with Obesity Hypoventilation Syndrome

    Other: Assessment

Interventions

  • OtherAssessment

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  3. 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.

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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).

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  3. Anthropometric Measurements - Hip Circumference

    Hip circumference is measured from the widest part of the hip, with the tape measure parallel to the floor.

    Time frame: 1 day

  4. Anthropometric Measurements - Neck Circumference

    Neck circumference is measured horizontally from the lower border of the laryngeal prominence with the head in an upright position.

    Time frame: 1 day

  5. 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.

    Time frame: 1 day

  6. 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.

    Time frame: 1 day

  7. Body Fluid Percentage

    Participants body fluid percentage will be measured using the 'Tanita BC-545N Body Analysis Scale' with the bioelectrical impedance analysis method.

    Time frame: 1 day

  8. Body Fat Percentage

    Participants body fat percentages will be evaluated using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique.

    Time frame: 1 day

  9. 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.

    Time frame: 1 day

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06766110
Responsible party
Nilgün Yıldız (Physiotherapist, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Jan 9, 2025
Start date
Jan 2025 (estimated)
Primary completion
Feb 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Jan 9, 2025

Study contacts

Nilgün Yıldız
Contact
yildiznilgunn@gmail.com
+905335068683

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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