- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06916923
Dysfunctional Breathing, Exercise Capacity, and Balance in Hypertension
February 6, 2026 updated by: Elif Kabasakal, Istinye University
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istınye University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Medication change within the last month prior to study enrollment
- Presence of unstable metabolic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline
|
|
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.
|
At baseline
|
|
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.
|
At baseline
|
|
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
|
At baseline
|
|
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.
|
At baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kabasakal, Istinye University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2025
Primary Completion (Actual)
February 15, 2025
Study Completion (Actual)
July 15, 2025
Study Registration Dates
First Submitted
April 1, 2025
First Submitted That Met QC Criteria
April 1, 2025
First Posted (Actual)
April 8, 2025
Study Record Updates
Last Update Posted (Actual)
February 10, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISU-2025-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arterial Hypertension
-
VIVUS LLCNot yet recruitingPulmonary Arterial Hypertension | Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) | Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension WHO Group I | Pulmonary Arterial Hypertension PAH
-
Rutgers, The State University of New JerseyRecruitingPulmonary Arterial Hypertension | Pulmonary Hypertension | Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) | Pulmonary Arterial Hypertension of Congenital Heart Disease | Pulmonary Arterial Hypertension Associated With Schistosomiasis (Disorder) | Pulmonary Arterial and Chronic Thromboembolic... and other conditionsUnited States
-
Inhibikase TherapeuticsNot yet recruitingPulmonary Arterial Hypertension (PAH)
-
Philipps University MarburgMSD Sharp & Dohme GmbH, GermanyNot yet recruiting
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...Not yet recruitingPulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)United States
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI); University of MichiganNot yet recruitingPulmonary Arterial Hypertension (PAH)United States
-
University of Sao Paulo General HospitalRecruitingPulmonary Arterial Hypertension (PAH)Brazil
-
University Hospital, BrestNot yet recruitingPulmonary Arterial Hypertension (PAH)France
-
Shanghai Zhongshan HospitalNot yet recruitingPulmonary Arterial Hypertension (PAH)
-
University of Sao Paulo General HospitalNot yet recruitingPulmonary Arterial Hypertension (PAH)Brazil