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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ieva Žemaitienė
- Numéro de téléphone: +37064822184
- E-mail: ieva.zemaitien@lsmu.lt
Sauvegarde des contacts de l'étude
- Nom: Kotryna Burneikaitė
- E-mail: kotrburn0213@kmu.lt
Lieux d'étude
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Kaunas, Lituanie, LT-53483
- LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
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Contact:
- Ieva Žemaitienė
- Numéro de téléphone: +37064822184
- E-mail: kulautuvos.reabilitacijos.ligonine@kaunoklinikos.lt
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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. |
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Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Thirty-Second Sit-to-Stand Test
Délai: Before and after 3 weeks of rehabilitation
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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
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Six-Minute Walk Test
Délai: Before and after 3 weeks of rehabilitation
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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
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Ten-Meter Walk Test
Délai: Before and after 3 weeks of rehabilitation
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Barthel Index
Délai: Before and after 3 weeks of rehabilitation
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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
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Pittsburgh Sleep Quality Index
Délai: Before and after 3 weeks of rehabilitation
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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
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Systolic Blood Pressure
Délai: Before and after 3 weeks of rehabilitation
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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
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Diastolic Blood Pressure
Délai: Before and after 3 weeks of rehabilitation
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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
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Heart Rate Measurement
Délai: Before and after 3 weeks of rehabilitation
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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
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Accident vasculaire cérébral
- AVC ischémique
- Ischémie cérébrale
- Activité motrice
- Mouvement
- Phénomènes physiologiques musculo-squelettiques
- Phénomènes physiologiques musculo-squelettiques et neuronaux
- Exercice
Autres numéros d'identification d'étude
- BE-2-65/2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
6 months after publication of the primary study results.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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