Dysfunctional BreathingNCT06916923
Dysfunctional Breathing, Exercise Capacity, and Balance in Hypertension
An observational study of Dysfunctional Breathing and Arterial Hypertension, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This prospective cross-sectional study aims to investigate the relationship between dysfunctional breathing (DB), exercise capacity, and balance in patients with arterial hypertension (HT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dysfunctional Breathing, Arterial Hypertension, Exercise Capacity
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 15 Jul 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults aged 18 to 70 years who have been clinically diagnosed with arterial hypertension and have been under follow-up for at least six months. All participants must have a Nijmegen Questionnaire score of 23 or higher, indicating a probable presence of dysfunctional breathing. Individuals must be willing to voluntarily participate in the study. Participants with recent medication changes (within the past month) or with unstable metabolic diseases will be excluded.
Who may be able to join
- Aged between 18 and 70 years
- Diagnosed with hypertension and under follow-up for at least 6 months
- Willing to participate in the study voluntarily
- Nijmegen Questionnaire score of 23 or above
Who cannot join
- Medication change within the last month prior to study enrollment
- Presence of unstable metabolic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Dysfunctional Breathing, Exercise Capacity, and Balance in Patients With Hypertension: A Prospective Cross-Sectional Study
This prospective cross-sectional study aims to investigate the relationship between dysfunctional breathing (DB), exercise capacity, and balance in patients with arterial hypertension (HT). DB is characterized by abnormal breathing patterns and is associated with symptoms such as dyspnea and inefficient ventilation, regardless of the presence of organic respiratory disease. Hypertension may further exacerbate these symptoms and contribute to impaired exercise performance and postural balance. The study will assess DB using the Nijmegen Questionnaire, along with anthropometric measurements, balance tests, and functional exercise capacity evaluations. Findings may contribute to better understanding of respiratory dysfunctions in hypertensive individuals and their impact on physical performance.
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive Patients With Dysfunctional Breathing | Participants diagnosed with arterial hypertension who exhibit symptoms of dysfunctional breathing, as determined by the Nijmegen Questionnaire. Assessments will include anthropometric measurements, functional exercise capacity tests, and balance evaluations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Dysfunctional Breathing Level
Nijmegen Questionnaire: The questionnaire is used for the assessment and identification of respiratory dysfunction, unexplained respiratory symptoms, and hyperventilation syndrome indicators. It consists of 16 items covering neurological, cardiovascular, respiratory, gastrointestinal, and psychological factors. Each item is rated on a 5-point Likert scale, with a total score ranging from 0 to 64. Higher scores indicate an increased likelihood of respiratory dysfunction and hyperventilation syndrome. A score above 23 supports the possible diagnosis of dysfunctional breathing. The questionnaire has a sensitivity of 91% and a specificity of 95%. The Turkish version of the questionnaire has been validated and found to be reliable.
Measured: At baseline
Assessment of Balance-I
The Timed Up and Go Test is a method used to rapidly assess an individual's balance control. During the test, the participant is instructed to rise from a seated position in a chair, walk a distance of 3 meters, turn around a reference object, return to the chair, and sit down again. The time taken to complete the task is recorded in seconds. The test will be repeated three times, and the average of the three trials will be used for analysis.
Measured: At baseline
Assessment of Balance-II
The Berg Balance Scale is used to assess balance through progressively challenging tasks by reducing the level of support provided by the surface. The scale consists of 14 items, each scored from 0 to 4 (4: best performance, 0: poorest performance). A total score between 41-56 indicates a low risk of falling, 21-40 reflects a medium fall risk, and scores below 20 indicate a high fall risk.
Measured: At baseline
Neck Circumference Measurements
Neck circumference will be measured using a flexible plastic measuring tape at the level of the cricoid cartilage, with the participant in an upright and relaxed position
Measured: At baseline
Waist Circumference Measurement
Waist circumference will be measured using a flexible plastic measuring tape at the level of the iliac crest, with the participant standing upright and breathing normally.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start10 Jan 2025
- Primary completion15 Feb 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional BreathingStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kabasakal, Istinye University
- Investigators
- Kabasakal, Study chair, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916923
- Sponsor's protocol ID
- ISU-2025-002
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Dysfunctional Breathing, Exercise Capacity, and Balance in Patients With Hypertension: A Prospective Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06916923
- Acronym / sponsor ID
- ISU-2025-002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 8 Apr 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.
This prospective cross-sectional study aims to investigate the relationship between dysfunctional breathing (DB), exercise capacity, and balance in patients with arterial hypertension (HT). DB is characterized by abnormal breathing patterns and is associated with symptoms such as dyspnea and inefficient ventilation, regardless of the presence of organic respiratory disease. Hypertension may further exacerbate these symptoms and contribute to impaired exercise performance and postural balance. The study will assess DB using the Nijmegen Questionnaire, along with anthropometric measurements, balance tests, and functional exercise capacity evaluations. Findings may contribute to better understanding of respiratory dysfunctions in hypertensive individuals and their impact on physical performance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive Patients With Dysfunctional Breathing | – | –Participants diagnosed with arterial hypertension who exhibit symptoms of dysfunctional breathing, as determined by the Nijmegen Questionnaire. Assessments will include anthropometric measurements, functional exercise capacity tests, and balance evaluations. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 18 to 70 years who have been clinically diagnosed with arterial hypertension and have been under follow-up for at least six months. All participants must have a Nijmegen Questionnaire score of 23 or higher, indicating a probable presence of dysfunctional breathing. Individuals must be willing to voluntarily participate in the study. Participants with recent medication changes (within the past month) or with unstable metabolic diseases will be excluded.
Key inclusion criteria (4 listed)
- Aged between 18 and 70 years
- Diagnosed with hypertension and under follow-up for at least 6 months
- Willing to participate in the study voluntarily
- Nijmegen Questionnaire score of 23 or above
Key exclusion criteria (2 listed)
- Medication change within the last month prior to study enrollment
- Presence of unstable metabolic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Dysfunctional Breathing Level
Time frame: At baseline
Nijmegen Questionnaire: The questionnaire is used for the assessment and identification of respiratory dysfunction, unexplained respiratory symptoms, and hyperventilation syndrome indicators. It consists of 16 items covering neurological, cardiovascular, respiratory, gastrointestinal, and psychological factors. Each item is rated on a 5-point Likert scale, with a total score ranging from 0 to 64. Higher scores indicate an increased likelihood of respiratory dysfunction and hyperventilation syndrome. A score above 23 supports the possible diagnosis of dysfunctional breathing. The questionnaire has a sensitivity of 91% and a specificity of 95%. The Turkish version of the questionnaire has been validated and found to be reliable.
Assessment of Balance-I
Time frame: At baseline
The Timed Up and Go Test is a method used to rapidly assess an individual's balance control. During the test, the participant is instructed to rise from a seated position in a chair, walk a distance of 3 meters, turn around a reference object, return to the chair, and sit down again. The time taken to complete the task is recorded in seconds. The test will be repeated three times, and the average of the three trials will be used for analysis.
Assessment of Balance-II
Time frame: At baseline
The Berg Balance Scale is used to assess balance through progressively challenging tasks by reducing the level of support provided by the surface. The scale consists of 14 items, each scored from 0 to 4 (4: best performance, 0: poorest performance). A total score between 41-56 indicates a low risk of falling, 21-40 reflects a medium fall risk, and scores below 20 indicate a high fall risk.
Neck Circumference Measurements
Time frame: At baseline
Neck circumference will be measured using a flexible plastic measuring tape at the level of the cricoid cartilage, with the participant in an upright and relaxed position
Waist Circumference Measurement
Time frame: At baseline
Waist circumference will be measured using a flexible plastic measuring tape at the level of the iliac crest, with the participant standing upright and breathing normally.
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 10 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
Kabasakal study chair
Istinye University
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 Dysfunctional Breathing and Arterial Hypertension, 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 4 inclusion and 2 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 10 Feb 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?
Assessment of Dysfunctional Breathing Level (time frame: At baseline). The study lists 5 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 10 Feb 2026.