- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07577960
Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns
The Effect of Pulmonary Rehabilitation on Respiratory Parameters in Individuals With Upper Extremity Burns
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Burn injuries may lead to physical limitations, functional loss, and respiratory problems. In individuals with upper extremity burns, pain, scar tissue, and reduced mobility of the shoulder girdle and chest wall may affect breathing mechanics and respiratory muscle performance. These changes may reduce ventilatory capacity and functional capacity during daily activities.
This randomized controlled clinical study will investigate the effects of a pulmonary rehabilitation program in adults with upper extremity burns. The study will be conducted at the Burn Center of Kartal Dr. Lütfi Kırdar City Hospital. Adults aged 18 to 65 years who had an upper extremity burn injury 3 to 12 months before enrollment and who meet the eligibility criteria will be included.
A total of 64 participants will be randomly assigned to two groups: a pulmonary rehabilitation group and a control group. The pulmonary rehabilitation group will receive respiratory muscle training combined with upper extremity aerobic exercises. The control group will receive a conventional exercise program. The intervention period will last 6 weeks.
Participants will be assessed at three time points: before the intervention, at week 3, and after the 6-week intervention. Respiratory function will be assessed using spirometry, including forced vital capacity, forced expiratory volume in one second, and maximum voluntary ventilation. Respiratory muscle activity will be evaluated using surface electromyography. Respiratory muscle thickness and diaphragm excursion will be assessed using ultrasonography. Functional capacity will be measured with the 6-minute walk test.
The study aims to determine whether pulmonary rehabilitation can improve respiratory function, respiratory muscle activity, respiratory muscle morphology, and functional capacity in individuals with upper extremity burns.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Kartal
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Istanbul, Kartal, Turcja (Türkiye), 34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adults aged 18 to 65 years
- History of upper extremity burn injury 3 to 12 months before enrollment
- Clinically stable condition, including oxygen saturation greater than 92% and cardiac stability
- Ability to communicate and follow instructions, with no hearing, cognitive, or motor communication impairment
- Voluntary agreement to participate in the study and signing the informed consent form
Exclusion Criteria:
- Burns involving the lower extremity, trunk, or head and neck regions
- History of chronic pulmonary, cardiac, neurological, or musculoskeletal disease
- Dependence on mechanical ventilation or respiratory support
- Severe psychiatric disorder or cognitive impairment
- Pregnancy
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Pulmonary Rehabilitation Group
Participants in this group will receive a 6-week pulmonary rehabilitation program including respiratory muscle training and upper extremity aerobic exercises.
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Participants in the experimental group will receive a 6-week pulmonary rehabilitation program in addition to the conventional exercise program.
The pulmonary rehabilitation program will include respiratory muscle training and upper extremity aerobic exercises.
Respiratory muscle training will be performed to improve inspiratory and expiratory muscle performance.
Upper extremity aerobic exercises will be planned according to the participant's clinical status and tolerance, with the aim of improving respiratory function, chest wall mobility, exercise tolerance, and functional capacity.
Exercises will be progressed gradually during the intervention period, and participants will be monitored for dyspnea, fatigue, oxygen desaturation, and pain during the sessions.
Participants in both groups will receive a 6-week conventional exercise program as standard rehabilitation.
The program will include routine rehabilitation exercises commonly used for individuals with upper extremity burns.
Exercises will focus on maintaining and improving upper extremity range of motion, flexibility, scar-related mobility, posture, and functional use of the affected limb.
The program may include active and active-assisted range of motion exercises, stretching exercises, mobility exercises for the shoulder, elbow, wrist, and hand, and functional upper extremity activities according to the participant's clinical condition and tolerance.
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Aktywny komparator: Conventional Exercise Group
Participants in this group will receive a 6-week conventional exercise program.
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Participants in both groups will receive a 6-week conventional exercise program as standard rehabilitation.
The program will include routine rehabilitation exercises commonly used for individuals with upper extremity burns.
Exercises will focus on maintaining and improving upper extremity range of motion, flexibility, scar-related mobility, posture, and functional use of the affected limb.
The program may include active and active-assisted range of motion exercises, stretching exercises, mobility exercises for the shoulder, elbow, wrist, and hand, and functional upper extremity activities according to the participant's clinical condition and tolerance.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Forced Vital Capacity
Ramy czasowe: Baseline, week 3, and week 6
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Pulmonary function will be assessed using forced vital capacity measured with a portable spirometry device according to American Thoracic Society and European Respiratory Society standards.
Forced vital capacity will be reported in liters.
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Baseline, week 3, and week 6
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Change in Forced Expiratory Volume in One Second
Ramy czasowe: Baseline, week 3, and week 6
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Pulmonary function will be assessed using forced expiratory volume in one second measured with a portable spirometry device according to American Thoracic Society and European Respiratory Society standards.
Forced expiratory volume in one second will be reported in liters.
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Baseline, week 3, and week 6
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Change in Maximum Voluntary Ventilation
Ramy czasowe: Baseline, week 3, and week 6
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Pulmonary function will be assessed using maximum voluntary ventilation measured with a portable spirometry device according to American Thoracic Society and European Respiratory Society standards.
Maximum voluntary ventilation will be reported in liters per minute.
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Baseline, week 3, and week 6
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Change in Diaphragm Thickness During Inspiration
Ramy czasowe: Baseline, week 3, and week 6
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Diaphragm thickness during inspiration will be assessed using ultrasonography to evaluate changes in diaphragm morphology over time.
Diaphragm thickness during inspiration will be reported in millimeters.
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Baseline, week 3, and week 6
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Change in Diaphragm Thickness During Expiration
Ramy czasowe: Baseline, week 3, and week 6
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Diaphragm thickness during expiration will be assessed using ultrasonography to evaluate changes in diaphragm morphology over time.
Diaphragm thickness during expiration will be reported in millimeters.
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Baseline, week 3, and week 6
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Change in Diaphragm Excursion
Ramy czasowe: Baseline, week 3, and week 6
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Diaphragm excursion will be assessed using ultrasonography to evaluate changes in diaphragm mobility over time.
Diaphragm excursion will be reported in millimeters.
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Baseline, week 3, and week 6
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Change in 6-Minute Walk Distance
Ramy czasowe: Baseline, week 3, and week 6
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Functional capacity will be assessed using the 6-minute walk test.
The distance walked during the test will be recorded in meters.
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Baseline, week 3, and week 6
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Sümeyye Akçay, Fenerbahçe University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- KartalH
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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