- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07627009
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
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Kocaeli
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İzmit, Kocaeli, Турция (Туркие), 41100
- Рекрутинг
- Kocaeli University
-
Контакт:
- Yasemin Özhanlı
- Номер телефона: 05393094695
- Электронная почта: yasemin.ozhanli@kocaeli.edu.tr
-
Контакт:
- MUSTAFA CANİKOĞLU, Assist. Prof.
- Номер телефона: 05424257817
- Электронная почта: mustafa.canikoglu@kocaeli.edu.tr
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Активный компаратор: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Oxygen Saturation SpO₂
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Respiratory Rate
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: MUSTAFA CANİKOĞLU, Assist. Prof, Kocaeli University
- Учебный стул: Yasemin Özhanlı, Assist. Prof, Kocaeli University
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- KOU-CVS-ROM-DB-2026
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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