Upper Extremity Exercises With and Without Deep Breathing After Cardiac Surgery (ROM-DB)
Evaluation of the Effects of Upper Extremity Range of Motion Exercises Performed With and Without Deep Breathing on Respiratory Parameters After Cardiac Surgery: A Randomized Trials
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Postoperative pulmonary complications are common after cardiac surgery and may include atelectasis, pulmonary edema, hypoxemia, reduced lung volumes, impaired thoracic mobility, and respiratory muscle dysfunction. Median sternotomy, postoperative pain, fear of movement, prolonged immobilization, and changes in respiratory mechanics may contribute to impaired pulmonary function during the early postoperative period.
Postoperative physiotherapy, early mobilization, breathing exercises, and range of motion exercises are commonly included in standard postoperative care after cardiac surgery. Deep breathing exercises are recommended to support lung expansion and improve pulmonary function, while upper extremity range of motion exercises may contribute to thoracic mobility, postural drainage, secretion clearance, and functional recovery. However, evidence regarding the immediate effects of standardized upper extremity exercises on respiratory parameters after open cardiac surgery remains limited.
Previous studies have examined respiratory physiotherapy, mobilization, and exercise-based interventions after cardiac surgery, and some evidence suggests potential benefits on lung function and inspiratory capacity. Nevertheless, the specific contribution of upper extremity range of motion exercises performed with versus without deep breathing has not been sufficiently clarified. This study is designed to compare the immediate effects of these two standardized exercise protocols on oxygen saturation, tidal volume, respiratory rate, heart rate, pain, perceived exertion, and dyspnea in patients after cardiac surgery.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Kocaeli
-
İzmit, Kocaeli, Turquía (Türkiye), 41100
- Reclutamiento
- Kocaeli University
-
Contacto:
- Yasemin Özhanlı
- Número de teléfono: 05393094695
- Correo electrónico: yasemin.ozhanli@kocaeli.edu.tr
-
Contacto:
- MUSTAFA CANİKOĞLU, Assist. Prof.
- Número de teléfono: 05424257817
- Correo electrónico: mustafa.canikoglu@kocaeli.edu.tr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- underwent elective open-heart surgery,
- stayed in the cardiovascular ICU for at least 2 nights post-operatively,
- had FiO2 below 40% (Spo2 will be kept above 92),
- were conscious,
- could speak Turkish,
- were willing to participate in the study.
Exclusion Criteria:
underwent another thoracic surgery or repeat surgery simultaneously,
- had any limb loss,
- underwent prolonged immobilization and intubation,
- developed serious complications such as infection or respiratory failure after surgery,
- had problems such as paresthesia, plegia, etc. after stroke, or had diseases such as Parkinson's that affect the level of relaxa
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Deep Breathing followed by ROM with Deep Breathing
Participants will first perform deep breathing exercises alone, followed by upper extremity range of motion exercises combined with deep breathing.
|
Participants will perform slow and deep breathing exercises in a sitting position.
Measurements will be recorded before and immediately after the intervention.
Participants will perform bilateral upper extremity range of motion exercises while taking a slow deep breath during arm elevation and exhaling during arm lowering.
The exercise will be repeated five times in a sitting position.
Measurements will be recorded before and immediately after the intervention.
|
|
Comparador activo: ROM with Deep Breathing followed by Deep Breathing
Participants will first perform upper extremity range of motion exercises combined with deep breathing, followed by deep breathing exercises alone.
|
Participants will perform slow and deep breathing exercises in a sitting position.
Measurements will be recorded before and immediately after the intervention.
Participants will perform bilateral upper extremity range of motion exercises while taking a slow deep breath during arm elevation and exhaling during arm lowering.
The exercise will be repeated five times in a sitting position.
Measurements will be recorded before and immediately after the intervention.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Oxygen Saturation SpO₂
Periodo de tiempo: Baseline and immediately after each intervention.
|
Oxygen saturation will be measured using a bedside clinical monitor or pulse oximeter.
SpO₂ represents the percentage of hemoglobin saturated with oxygen in the blood and will be recorded as a percentage.
Higher values indicate better oxygenation.
|
Baseline and immediately after each intervention.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Respiratory Rate
Periodo de tiempo: Baseline and immediately after each intervention.
|
Respiratory rate will be assessed as the number of breaths taken per minute and recorded as breaths per minute
|
Baseline and immediately after each intervention.
|
|
Change in Heart Rate
Periodo de tiempo: Baseline and immediately after each intervention.
|
Heart rate will be measured using a bedside clinical monitor and recorded as beats per minute.
|
Baseline and immediately after each intervention.
|
|
Change in Pain Intensity Assessed by the Numeric Rating Scale
Periodo de tiempo: Baseline and immediately after each intervention.
|
Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10. Higher scores indicate greater pain intensity.
|
Baseline and immediately after each intervention.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: MUSTAFA CANİKOĞLU, Assist. Prof, Kocaeli University
- Silla de estudio: Yasemin Özhanlı, Assist. Prof, Kocaeli University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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
Otros números de identificación del estudio
- KOU-CVS-ROM-DB-2026
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.
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. .