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Functional Outcomes in Patients With Cerebral Infarction After Aquatic Physiotherapy and Aerobic Exercise

7 de octubre de 2026 actualizado por: Ieva Žemaitienė, Lithuanian University of Health Sciences

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

45 años a 74 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Thirty-Second Sit-to-Stand Test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Barthel Index
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2028

Fechas de registro del estudio

Enviado por primera vez

22 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de octubre de 2026

Publicado por primera vez (Actual)

6 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de octubre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir IPD

6 months after publication of the primary study results.

Criterios de acceso compartido de 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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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