ObesityNCT07122804
Hyperventilation and Physical Performance in Obesity
An observational study of Obesity, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Assessment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Individuals aged 18-65 with a Body Mass Index (BMI) ≥ 30 kg/m²
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Hyperventilation Symptoms and Physical Performance in Obese Individuals: An Observational Study
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- Assessment
- Keywords
- Hyperventilation symptoms, Respiratory function, Physical performance
- Medical subject headings
- Obesity, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Within the scope of the study, without any intervention, data regarding the participants' hyperventilation symptoms and physical capacities will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 4 weeks
Secondary outcomes (1)
Quality of Life Instrument for Obese Individuals
The Quality of Life Instrument for Obese Individuals is a self-reported scale developed to evaluate obesity-specific quality of life and to assess the multidimensional impact of weight on quality of life in obese individuals. It measures the effects on areas such as physical functioning, self-esteem, sexual life, public distress, and work life. The instrument consists of thirty-one items and five subscales. Participants rate each statement on a five-point Likert-type scale ranging from "strongly disagree" (1) to "strongly agree" (5). The Turkish validity and reliability study of the instrument was conducted in 2024.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start15 Aug 2025
- Primary completion15 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Koce, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122804
- Sponsor's protocol ID
- 2025/230
- Status last verified
- Apr 2026
- First submitted
- 8 Aug 2025
- Last updated
- 9 Apr 2026
- 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Hyperventilation Symptoms and Physical Performance in Obese Individuals: An Observational Study
- ClinicalTrials.gov ID
- NCT07122804
- Acronym / sponsor ID
- 2025/230
- Conditions
- Obesity
- Keywords
- Hyperventilation symptoms, Respiratory function, Physical performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 14 Aug 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: AssessmentIndividuals 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 18-65 with a Body Mass Index (BMI) ≥ 30 kg/m²
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| AssessmentWithin the scope of the study, without any intervention, data regarding the participants' hyperventilation symptoms and physical capacities will be evaluated. | Other | Group 1 |
Primary outcome
Nijmegen Questionnaire:
Time frame: 4 weeks
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
Chest Circumference Measurement
Time frame: 4 weeks
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
Modified Borg Scale
Time frame: 4 weeks
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.
Six-Minute Walk Test
Time frame: 4 weeks
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
Timed Up and Go Test
Time frame: 4 weeks
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
Thirty-Second Sit-to-Stand Test
Time frame: 4 weeks
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
Modified Plank Test
Time frame: 4 weeks
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.
1 secondary outcome
Quality of Life Instrument for Obese Individuals
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Istinye University 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 9 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nijmegen Questionnaire: (time frame: 4 weeks). The study lists 7 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 Apr 2026.