NCT07122804

Brief Summary

Obesity has become a major public health concern worldwide due to its rapidly increasing prevalence. It is defined as an abnormal or excessive accumulation of body fat that may impair health. Obesity is associated not only with chronic conditions such as cardiovascular diseases, type 2 diabetes, osteoarthritis, and certain types of cancer, but also with impaired respiratory function. Excess body mass can reduce the range of motion of the respiratory muscles, limit the mechanical function of the chest wall and diaphragm, and decrease the efficiency of ventilation. As a result, individuals with obesity often experience exertional shortness of breath, rapid breathing, and inadequate ventilation. These symptoms may be considered part of hyperventilation syndrome, which is characterized by altered respiratory control and influenced by both physiological and psychological factors. Although some studies have reported the presence of hyperventilation symptoms in individuals with obesity, their impact on physical performance has not been adequately investigated. Hyperventilation can limit the ability to perform daily activities and may lead to fatigue, imbalance, and other problems that directly affect physical performance. The aim of this study is to examine the relationship between hyperventilation symptoms and physical performance parameters in individuals with obesity. The findings are expected to contribute to a more comprehensive assessment of physical fitness in this population and to support the development of individualized physiotherapy interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

August 8, 2025

Last Update Submit

April 3, 2026

Conditions

Keywords

Hyperventilation symptomsRespiratory functionPhysical performance

Outcome Measures

Primary Outcomes (7)

  • Nijmegen Questionnaire:

    The Nijmegen Questionnaire is a 16-item self-reported scale used to assess the subjective symptoms of hyperventilation syndrome. Each item is scored between 0 and 4, and individuals with a total score of 23 or higher are considered to have a high risk of hyperventilation

    4 weeks

  • Chest Circumference Measurement

    This is a simple anthropometric measurement used to indirectly assess respiratory capacity. The chest circumference is measured with a measuring tape during maximum inspiration and maximum expiration, and the difference between the two values is calculated

    4 weeks

  • Modified Borg Scale

    The Modified Borg Scale is a subjective tool used to measure perceived exertion and shortness of breath. It is rated from 0 (no difficulty) to 10 (maximum difficulty). It is particularly preferred for evaluations before and after the Six-Minute Walk Test.

    4 weeks

  • Six-Minute Walk Test

    The Six-Minute Walk Test is a practical and reliable field test used to evaluate lower extremity aerobic capacity and endurance. The individual is asked to walk as quickly as possible for six minutes along a flat corridor, and the total distance covered is recorded

    4 weeks

  • Timed Up and Go Test

    The Timed Up and Go Test is a practical and valid performance test used to evaluate mobility, balance, and functional movement abilities. In this test, the participant stands up from a chair, walks three meters, turns around, walks back, and sits down again. The time is measured in seconds, with shorter times indicating better functional performance. The Timed Up and Go Test is widely used to identify fall risk and mobility limitations, especially in older adults

    4 weeks

  • Thirty-Second Sit-to-Stand Test

    The Thirty-Second Sit-to-Stand Test is a functional test used to assess lower extremity muscle endurance. The participant is asked to stand up from and sit down on a chair as many times as possible within thirty seconds, and the number of repetitions is recorded

    4 weeks

  • Modified Plank Test

    The Modified Plank Test is a simple and safe test used to evaluate core stability. The participant is asked to maintain a plank position, supported on the elbows and knees, for as long as possible. The duration is measured in seconds.

    4 weeks

Secondary Outcomes (1)

  • Quality of Life Instrument for Obese Individuals

    4 weeks

Study Arms (1)

Group 1

Individuals aged between 18 and 65 years, with a Body Mass Index (BMI) ≥ 30 kg/m², who have the ability to understand and respond to the questionnaires and tests used in the study.

Other: Assessment

Interventions

Within the scope of the study, without any intervention, data regarding the participants' hyperventilation symptoms and physical capacities will be evaluated.

Group 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals aged 18-65 with a Body Mass Index (BMI) ≥ 30 kg/m²

You may qualify if:

  • Being between 18 and 65 years of age
  • Having a Body Mass Index of 30 kilograms per square meter or higher (diagnosis of obesity)
  • Providing written informed consent by signing the informed volunteer consent form after receiving information about the study
  • Having sufficient physical and cognitive ability to individually perform the test procedures
  • Being able to read and understand the Turkish language

You may not qualify if:

  • Having a diagnosis of acute or chronic cardiovascular, pulmonary, rheumatological, neurological, or orthopedic disease
  • Having a history of psychiatric illness (such as major depression, schizophrenia, or bipolar disorder)
  • Having undergone major surgical operation within the past six months
  • Having a level of physical limitation that prevents independent performance of daily living activities
  • Being pregnant or in the breastfeeding period
  • Having language, attention, or communication disorders that would prevent the administration of the Nijmegen Questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityRespiratory Aspiration

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 14, 2025

Study Start

August 15, 2025

Primary Completion

February 15, 2026

Study Completion

February 28, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations