Functional Outcomes in Patients With Cerebral Infarction After Aquatic Physiotherapy and Aerobic Exercise
Changes in Functional Outcomes in Patients With Cerebral Infarction Following Aquatic Physiotherapy and Aerobic Exercise
The aim of the study was to evaluate changes in functional outcomes in patients with cerebral infarction following aquatic physiotherapy and aerobic exercises during the second stage of rehabilitation.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ieva Žemaitienė
- 電話番号：+37064822184
- メール：ieva.zemaitien@lsmu.lt
研究連絡先のバックアップ
- 名前：Kotryna Burneikaitė
- メール：kotrburn0213@kmu.lt
研究場所
-
-
-
Kaunas、リトアニア、LT-53483
- LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
-
コンタクト：
- Ieva Žemaitienė
- 電話番号：+37064822184
- メール：kulautuvos.reabilitacijos.ligonine@kaunoklinikos.lt
-
-
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
説明
Inclusion Criteria:
- Muscle strength of 4-5 points, assessed using manual muscle testing.
- Ability to walk independently or with the use of an assistive device.
- Stable cardiovascular status, based on the results of a physician's examination and the participant's medical history.
- First-ever cerebral infarction.
- Participants aged 45-74 years.
- Mini-Mental State Examination (MMSE) score of 11-30 points, based on the patient's medical records and the assessment performed by psychologists working at Kulautuva Rehabilitation Hospital.
Exclusion Criteria:
- Muscle strength of less than 4 points, assessed using manual muscle testing.
- Inability to walk independently or with the use of an assistive device.
- Unstable cardiovascular status (uncontrolled arterial hypertension, angina --pectoris, cardiac arrhythmias, and other contraindications).
- Recurrent cerebral infarction.
- Participants younger than 45 years or older than 74 years.
- MMSE score below 11 points.
- Comorbidities that limit the ability to safely perform aquatic physiotherapy or aerobic exercises.
- Contraindications to aquatic physiotherapy (open wounds, skin diseases, etc.).
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
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Aquatic physiotherapy
Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The first group will receive aquatic physiotherapy for 30 minutes, 3 times per week, in addition to conventional physiotherapy for 60 minutes, 5 times per week. Participants will be allocated to the aquatic physiotherapy group using randomization to minimize selection bias and ensure comparable distribution of participants between the two groups. |
Aquatic physiotherapy will consist of a structured exercise program performed in water under the supervision of a physiotherapist. Each session will last 30 minutes and will be performed 3 times per week. |
|
実験的：Aerobic exercises
Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The second group will receive aerobic exercise for 30 minutes, 3 times per week, in addition to conventional physiotherapy for 60 minutes, 5 times per week. Participants will be allocated to the aerobic exercise group using randomization to minimize selection bias and ensure comparable distribution of participants between the two groups. |
Aerobic exercise will consist of a continuous 30-minute cyclical aerobic exercise session performed on a stationary bicycle under the supervision of a physiotherapist. The session will be performed 3 times per week. |
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 |
|---|---|---|
|
Thirty-Second Sit-to-Stand Test
時間枠：Before and after 3 weeks of rehabilitation
|
The Thirty-Second Sit-to-Stand Test will be used to assess lower-extremity muscle strength by measuring the number of complete sit-to-stand repetitions performed in thirty seconds. Minimum 0 repetitions, no fixed maximum; higher scores indicate better lower-extremity functional strength. |
Before and after 3 weeks of rehabilitation
|
|
Six-Minute Walk Test
時間枠：Before and after 3 weeks of rehabilitation
|
The Six-Minute Walk Test will be used to assess functional exercise capacity by measuring the distance walked during six minutes. Six-Minute Walk Test: minimum 0 meters, no fixed maximum; greater distances indicate better walking endurance. |
Before and after 3 weeks of rehabilitation
|
|
Ten-Meter Walk Test
時間枠：Before and after 3 weeks of rehabilitation
|
The Ten-Meter Walk Test will be used to assess walking speed by measuring the time required to walk ten meters. Minimum 0 seconds, no fixed maximum; lower completion times indicate better walking performance. |
Before and after 3 weeks of rehabilitation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Barthel Index
時間枠：Before and after 3 weeks of rehabilitation
|
The Barthel Index will be used to assess the patient's independence in activities of daily living. Minimum 0, maximum 100; higher scores indicate greater independence in activities of daily living. |
Before and after 3 weeks of rehabilitation
|
|
Pittsburgh Sleep Quality Index
時間枠：Before and after 3 weeks of rehabilitation
|
The Pittsburgh Sleep Quality Index will be used to assess the patient's sleep quality and sleep disturbances. Minimum 0, maximum 21; higher scores indicate worse sleep quality. |
Before and after 3 weeks of rehabilitation
|
|
Systolic Blood Pressure
時間枠：Before and after 3 weeks of rehabilitation
|
Systolic blood pressure will be measured to assess the cardiovascular response to physical exercise. Measured in millimeters of mercury (mmHg); no fixed minimum or maximum values; higher or lower values are not inherently better or worse, as interpretation depends on the clinical context. |
Before and after 3 weeks of rehabilitation
|
|
Diastolic Blood Pressure
時間枠：Before and after 3 weeks of rehabilitation
|
Diastolic blood pressure will be measured to assess the cardiovascular response to physical exercise. Measured in millimeters of mercury (mmHg); no fixed minimum or maximum values; higher or lower values are not inherently better or worse, as interpretation depends on the clinical context. |
Before and after 3 weeks of rehabilitation
|
|
Heart Rate Measurement
時間枠：Before and after 3 weeks of rehabilitation
|
Heart rate will be measured to assess the cardiovascular response to physical exercise. Heart rate measured in beats per minute (bpm); no fixed minimum or maximum values; higher or lower values are not inherently better or worse, as interpretation depends on the clinical context. |
Before and after 3 weeks of rehabilitation
|
協力者と研究者
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BE-2-65/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Coded, de-identified individual participant data collected before and after the intervention will be shared, including results of the 6-Minute Walk Test, 10-Meter Walk Test, 30-Second Sit-to-Stand Test, Barthel Index, Sleep Quality Index questionnaire, as well as blood pressure and heart rate measurements.
IPD 共有時間枠
6 months after publication of the primary study results.
IPD 共有アクセス基準
Access to the coded, de-identified individual participant data and supporting information will be provided to qualified researchers upon reasonable request and approval by the study investigators. Access will be granted for scientifically valid research purposes and subject to applicable ethical and data protection requirements. Researchers will be able to access the individual participant data and study protocol. Requests for access should be submitted to the study investigators.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。