Dysfunctional Breathing, Exercise Capacity, and Balance in Hypertension

NCT06916923 | Completed

• 1 other identifier: ISU-2025-002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Exercise Capacity; Dysfunctional Breathing; Arterial Hypertension; Balance

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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

  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.

  At baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Medication change within the last month prior to study enrollment
• Presence of unstable metabolic disease

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istınye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kabasakal

  Istinye University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: January 10, 2025
• Primary Completion: February 15, 2025
• Study Completion: July 15, 2025
• Last Updated: February 10, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)