Symptomatic Hyperventilation in Individuals Living With Stroke
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.
調査の概要
状態
研究の種類
入学 (推定)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Hyperventilation Syndrome Group
|
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
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1 % predicted)
時間枠：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)
時間枠：Measured at baseline/assessment.
|
Maximal inspiratory pressure will be assessed to determine respiratory muscle strength. |
Measured at baseline/assessment.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximal expiratory pressure (PEmax)
時間枠：Measured at baseline/assessment.
|
Maximal expiratory pressure will be assessed to determine respiratory muscle strength. |
Measured at baseline/assessment.
|
|
Respiratory Muscle Endurance Score
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：Measured at baseline/assessment.
|
The six-minute walk test will be performed to measure functional capacity distance in meters. |
Measured at baseline/assessment.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。