Symptomatic Hyperventilation in Individuals Living With Stroke

September 19, 2026 updated by: Yunus Emre Tutuneken, Istinye University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

92

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will comprise adult individuals diagnosed with stroke (ischaemic or haemorrhagic) who are in the post-stroke period. Participants will be recruited and screened based on the Nijmegen Questionnaire score to form two distinct cohorts: individuals presenting with symptomatic hyperventilation syndrome and individuals without hyperventilation syndrome.

Description

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.

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

  • Observational Models: OTHER
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hyperventilation Syndrome Group
Other: Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments

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.
Without Hyperventilation Syndrome Group
Other: Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at baseline/assessment
Maximal inspiratory pressure (PImax)
Time Frame: Measured at baseline/assessment.

Maximal inspiratory pressure will be assessed to determine respiratory muscle strength.
Measured at baseline/assessment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal expiratory pressure (PEmax)
Time Frame: Measured at baseline/assessment.

Maximal expiratory pressure will be assessed to determine respiratory muscle strength.
Measured at baseline/assessment.
Respiratory Muscle Endurance Score
Time Frame: Measured at baseline/assessment.

Respiratory muscle endurance scores will be recorded to evaluate breathing endurance between groups.
Measured at baseline/assessment.
Forced Vital Capacity (FVC)
Time Frame: Measured at baseline/assessment.

FVC percentage value will be analyzed to assess restrictive patterns and flow rates.
Measured at baseline/assessment.
Peak Expiratory Flow (PEF)
Time Frame: Measured at baseline/assessment.

PEF value will be analyzed to assess restrictive patterns and flow rates.
Measured at baseline/assessment.
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.
Measured at baseline/assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 (Estimated)

September 25, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

September 19, 2026

First Submitted That Met QC Criteria

September 19, 2026

First Posted (Actual)

September 25, 2026

Study Record Updates

Last Update Posted (Actual)

September 25, 2026

Last Update Submitted That Met QC Criteria

September 19, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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