NCT07840703

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Sep 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

September 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 19, 2026

Last Update Submit

September 19, 2026

Conditions

Keywords

StrokeHyperventilation syndromeRespiratory muscle strengthRespiratory muscle endurancePulmonary functionFunctional capacity

Outcome Measures

Primary Outcomes (2)

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

    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)

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

    Measured at baseline/assessment.

Secondary Outcomes (5)

  • Maximal expiratory pressure (PEmax)

    Measured at baseline/assessment.

  • Respiratory Muscle Endurance Score

    Measured at baseline/assessment.

  • Forced Vital Capacity (FVC)

    Measured at baseline/assessment.

  • Peak Expiratory Flow (PEF)

    Measured at baseline/assessment.

  • Six-Minute Walk Distance (6MWD)

    Measured at baseline/assessment.

Study Arms (2)

Hyperventilation Syndrome Group

Other: Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments

Without Hyperventilation Syndrome Group

Other: Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments

Interventions

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.

Hyperventilation Syndrome GroupWithout Hyperventilation Syndrome Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Assistant Professor

Study Record Dates

First Submitted

September 19, 2026

First Posted

September 25, 2026

Study Start

September 25, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09