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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07649330
Effects of Myofascial Release on Cardiac Patients After Median Sternotomy
After deciding to join this study and signing the informed consent form, participants will undergo the following interventions:
All participants will receive a preoperative assessment (Tp) before surgery. Within five days after transferring from the ICU to the general ward, participants will receive a baseline assessment (T0). After completing seven sessions of myofascial release (MFR), a post-intervention assessment (T1) will be conducted.
Assessments include maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), pulmonary function tests, mid- and lower-thoracic mobility, surface electromyography (sEMG) to measure diaphragmatic and sternocleidomastoid muscle activity, and pain scores. Pulmonary function tests include forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC ratio, and maximum voluntary ventilation (MVV).
Participants will be randomly assigned to an intervention group or a control group. The intervention group will receive myofascial release therapy in addition to routine physical therapy in the general ward. Routine therapy includes daily physical therapy sessions such as out-of-bed activities, incentive spirometry training (Triflow), and functional exercises. The MFR intervention consists of three steps:
The therapist places both hands on the thoracic outlet, with the index and middle fingers above the clavicle.
One hand is placed on the anterior chest and the other hand parallel on the participant's back.
Both hands are placed on the anterolateral region of the thoracoabdominal diaphragm.
During each step, participants are instructed to take 10 slow, deep breaths and direct airflow toward the therapist's hands. Each session lasts approximately 15 minutes, once daily, for seven sessions.
The control group will receive only routine physical therapy (out-of-bed activities, incentive spirometry, and functional exercises) without additional myofascial release therapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Siou Pin Huang, PT (Physical Therapist)
- Número de teléfono: +886 988 366 335
- Correo electrónico: qaz9650921@gmail.com
Ubicaciones de estudio
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Kaohsiung City, Taiwán
- Reclutamiento
- Kaohsiung Veterans General Hospital
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Contacto:
- Siou Pin Huang, PT (Physical Therapist)
- Número de teléfono: +886 988 366 335
- Correo electrónico: qaz9650921@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- Able to communicate verbally and follow instructions
- Diagnosed by a physician with coronary artery disease, valvular disease, or aortic disease
- Undergoing median sternotomy
- Able to provide informed consent
Exclusion Criteria:
- Presence of a cardiac pacemaker
- Presence of a ventricular assist device (VAD)
- Existing central nervous system disorders (e.g., hemorrhagic or ischemic stroke, spinal cord injury, traumatic brain injury)
- Cognitive impairment or inability to understand/follow instructions
- Diagnosed with chronic obstructive pulmonary disease (COPD)
- History of previous thoracic surgery
- ICU stay longer than 14 days
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: (Control Group) Arm Title: Control Group - Routine Physical Therapy
Routine Physical Therapy
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Participants in the control group will receive routine physical therapy only, including out-of-bed activities, incentive spirometry training (Triflow), and functional exercises.
No additional myofascial release therapy will be provided.
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Experimental: Experimental: (Intervention Group) Arm Title: Myofascial Release + Routine Physical Therapy
Experimental: (Intervention Group) Arm Title: Intervention Group - Myofascial Release+Routine Physical Therapy
|
Participants in the intervention group will receive seven daily sessions of myofascial release (MFR), approximately 15 minutes each, in addition to routine physical therapy. Routine therapy includes out-of-bed activities, incentive spirometry training (Triflow), and functional exercises. The MFR procedure consists of three steps: Therapist places both hands on the thoracic outlet, with index and middle fingers above the clavicle. One hand is placed on the anterior chest and the other parallel on the participant's back. Both hands are placed on the anterolateral thoracoabdominal region. During each step, participants are instructed to take 10 slow, deep breaths, directing airflow toward the therapist's hands. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Periodo de tiempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
1. Forced Vital Capacity (FVC)
Periodo de tiempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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1. Forced Vital Capacity (FVC) Unit of Measure: liters (L)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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|
Forced Expiratory Volume in 1 second (FEV1)
Periodo de tiempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Forced Expiratory Volume in 1 Second (FEV1) Unit of Measure: liters (L)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
|
FEV1/FVC ratio
Periodo de tiempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
FEV1/FVC Ratio Unit of Measure: percentage (%)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
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Maximal Voluntary Ventilation (MVV)
Periodo de tiempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Maximal Voluntary Ventilation (MVV) Unit of Measure: liters/minute (L/min)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
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Middle and Lower chest wall mobility
Periodo de tiempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Chest Wall Mobility Unit of Measure: centimeters (cm)
|
1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
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Diaphragm and sternocleidomastoid surface electromyography (sEMG)
Periodo de tiempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Diaphragm Surface Electromyography Activity Sternocleidomastoid Surface Electromyography Activity Unit of Measure: microvolts (µV)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
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Pain intensity
Periodo de tiempo: 1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Pain intensity measured using the Numeric Rating Scale (NRS).
(0-10)
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1. Baseline 2. Day 0-5 post-ICU transfer 3. Week 1
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Disección, Vaso Sanguíneo
- Síndrome aórtico agudo
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades cardíacas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Isquemia miocardica
- Enfermedades aórticas
- Aneurisma
- Enfermedad de la arteria coronaria
- Aneurisma aortico
- Disección aórtica
- Enfermedades de las válvulas cardíacas
Otros números de identificación del estudio
- AF02-008/15.1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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