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NCT Number: NCT06916923

Dysfunctional Breathing, Exercise Capacity, and Balance in Hypertension

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.

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Key information

Conditions

Dysfunctional Breathing Arterial Hypertension Balance Cardiovascular Diseases Exercise Capacity Hypertension Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istınye University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Relationship Between Dysfunctional Breathing, Exercise Capacity, and Balance in Patients With Hypertension: A Prospective Cross-Sectional Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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