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NCT Number: NCT07840703

Symptomatic Hyperventilation in Individuals Living With Stroke

This study will investigate the effects of hyperventilation syndrome on respiratory muscle strength, respiratory muscle endurance, pulmonary functions, and functional capacity in individuals living with stroke, and in this context, stroke patients with and without hyperventilation syndrome based on Nijmegen Questionnaire scores will be compared to evaluate the relationship between symptom burden and respiratory parameters.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hyperventilation Syndrome Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals who will be diagnosed with a confirmed first-ever or recurrent stroke (ischaemic or haemorrhagic) verified by neuroimaging (CT or MRI).
  • Individuals who will be in the chronic or subacute post-stroke period (medically stable following stroke onset).
  • Individuals aged 18 years and older.
  • Individuals who will be classified into either the hyperventilation syndrome group based on a Nijmegen Questionnaire score of ≥23 or the control group based on a score of <23.
  • Individuals who will be able to comprehend instructions and cooperate adequately with pulmonary function tests, respiratory muscle testing, and physical performance assessments.
  • Individuals who will provide written informed consent to participate in the study.

Exclusion criteria

  • Individuals who will present with severe cognitive impairment, aphasia, or psychiatric disorders that will prevent reliable completion of questionnaires (such as the Nijmegen Questionnaire) or cooperation with test procedures.
  • Individuals who will have pre-existing primary chronic obstructive pulmonary disease (COPD), asthma, restrictive thoracic diseases, or other major pre-existing pulmonary pathologies that will confound pulmonary function test results.
  • Individuals who will have unstable cardiovascular conditions (e.g., recent myocardial infarction within the past 3-6 months, unstable angina pectoris, uncontrolled malignant arrhythmias, or uncontrolled severe hypertension) that will pose a risk during physical testing (such as the six-minute walk test).
  • Individuals who will have severe orthopedic, musculoskeletal, or lower extremity peripheral disorders unrelated to stroke that will independently limit functional capacity and walking distance (6MWD).
  • Individuals who will have active respiratory tract infections or acute pulmonary illnesses at the time of evaluation. Individuals who will be participating in an active pulmonary rehabilitation program or receiving respiratory muscle training concurrently.

Treatment and study plan

Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments

Other

Both groups will undergo comprehensive evaluations including pulmonary function tests (FEV1, FVC, PEF), respiratory muscle strength (PImax, PEmax), respiratory muscle endurance tests, the Nijmegen Questionnaire, and the six-minute walk test (6MWT) to assess functional capacity.

Primary outcomes

  1. Change in Forced Expiratory Volume in One Second (FEV1 % predicted)

    Time frame: Measured at baseline/assessment

    FEV1 percent predicted values will be measured to evaluate and compare pulmonary function between the hyperventilation syndrome group and the control group.

  2. Maximal inspiratory pressure (PImax)

    Time frame: Measured at baseline/assessment.

    Maximal inspiratory pressure will be assessed to determine respiratory muscle strength.

Secondary outcomes

  1. Maximal expiratory pressure (PEmax)

    Time frame: Measured at baseline/assessment.

    Maximal expiratory pressure will be assessed to determine respiratory muscle strength.

  2. Respiratory Muscle Endurance Score

    Time frame: Measured at baseline/assessment.

    Respiratory muscle endurance scores will be recorded to evaluate breathing endurance between groups.

  3. Forced Vital Capacity (FVC)

    Time frame: Measured at baseline/assessment.

    FVC percentage value will be analyzed to assess restrictive patterns and flow rates.

  4. Peak Expiratory Flow (PEF)

    Time frame: Measured at baseline/assessment.

    PEF value will be analyzed to assess restrictive patterns and flow rates.

  5. Six-Minute Walk Distance (6MWD)

    Time frame: Measured at baseline/assessment.

    The six-minute walk test will be performed to measure functional capacity distance in meters.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Impact of Symptomatic Hyperventilation on Respiratory Parameters and Functional Capacity Among Individuals Living With Stroke: A Comparative Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2026
Registry last updated
Sep 25, 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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