NCT06766110

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

January 3, 2025

Last Update Submit

January 7, 2025

Conditions

Keywords

Obesity Hypoventilation Syndrome (OHS)upper extremity functionhand grip strengthactivities of daily living

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    1 day

Secondary Outcomes (9)

  • Body Mass Index

    1 day

  • Anthropometric Measurements - Waist Circumference

    1 day

  • Anthropometric Measurements - Hip Circumference

    1 day

  • Anthropometric Measurements - Neck Circumference

    1 day

  • Anthropometric Measurements - Arm Circumference

    1 day

  • +4 more secondary outcomes

Study Arms (1)

Subjects with Obesity Hypoventilation Syndrome

Other: Assessment

Interventions

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.

Subjects with Obesity Hypoventilation Syndrome

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Sleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 9, 2025

Study Start

January 1, 2025

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations