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Effect of Respiratory Exerciser on Pulmonary Functions of COVID-19 Patients

27 stycznia 2022 zaktualizowane przez: Kerem Ensarioğlu, Diskapi Yildirim Beyazit Education and Research Hospital

Effect of Respiratory Exerciser on Pulmonary Functions of COVID-19 Patients, A Prospective Observational Study

COVID-19 infection is the cause of the current pandemic, responsible for loss of life and disability at a rate unseen before. Among survivors, the infection may cause lasting damage, such as permanent loss of lung function.

This study aims to investigate if pulmonary rehabilitation done via supportive devices may reduce or prevent lung function injury. Patients will be chosen among COVID-19 patients who require hospitalization. Patients then will be divided into two groups, those who had used said devices, and compare them to those who had not used them for any reason. After a month, two groups will be evaluated by respiratory function tests, which are expected to provide the results required for a proper comparison.

Pulmonary rehabilitation provided by the supportive devices is expected to either lessen or eliminate a loss of pulmonary function over time, compared to the group who did not use them.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

SARS-CoV-2 is a novel coronavirus that is responsible for the current pandemic. Its clinical presentation varies from asymptomatic infection to severe respiratory failure requiring intensive care stay. Loss of respiratory function had been observed in survivors of other coronaviruses in earlier studies. The degree of respiratory function loss and if any intervention may reduce or prevent it remains an issue to be clarified.

The study's goal is to investigate the effects of pulmonary rehabilitation via a supporting device on COVID-19 patients during a follow-up period of one month. The primary method of investigation of pulmonary functions is comparing peak expiratory flow (PEF) at the time of diagnosis and after treatment.

The study hypothesizes that patients who had successfully used a respiratory exerciser or a similar aid device will have better PEF results at the end of the first-month evaluation.

The effect of an incentive spirometer and/or a respiratory exerciser on the pulmonary function results is the main element under investigation in this study. The hospital provides these devices, and in cases, patients demand another device, the patients and their relatives are asked to purchase such equipment.

Pulmonary function tests (PFT) are considered a part of routine evaluation for the COVID-19 patients a month after the treatment. Patients are considered suitable for PFT evaluation if the COVID-19 infectious process is deemed treated, and other contraindications for PFT are not present, such as recent surgery or pneumothorax.

Patients admitted to the pulmonary medicine ward for COVID-19 infection are generally those who already have respiratory comorbidity, including chronic obstructive pulmonary disease, asthma, concurrent pneumonia, and respiratory failure. Due to these reasons, PFT is not considered an acceptable evaluation method during the acute phase and is not requested. PEF testing, on the other hand, remains a simple yet effective alternative compared to PFT due to being more portable, the presence of disposable parts, and overall cost. It is the initial choice of evaluation for patients after a clinical response is seen to treatment and testing is deemed safe.

The respiratory exercise is considered a part of COVID-19 care, primarily due to patients' comorbidities, as mentioned above. This approach is limited in terms of healthcare personnel for on-point pulmonary rehabilitation due to both the disease's infectious nature and limited resources. Respiratory exercise devices are accepted as a reasonable alternative that can be quantitively monitored and provided on a daily basis.

This prospective study plans to evaluate the impact of respiratory exercise provided by incentive spirometers and respiratory exercisers. The evaluation will be performed by comparing the initial PEF result after the end of COVID-19 treatment and subsequent ward discharge; to the PEF result of the PFT evaluation at the end of the first month.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

14

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Indyk
    • Çankaya
      • Ankara, Çankaya, Indyk, 06110
        • Dışkapı Yıldırım Beyazıt Training and Research Hospital Pulmonary Medicine Clinic

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Patients will be selected among those who apply to emergency service and evaluated by a pulmonary medicine resident or specialist. Among this population, further selection will be performed via the inclusion and exclusion criteria.

Opis

Inclusion Criteria:

  1. Being at least 18 years or older
  2. Approval given both written and orally to the study participation
  3. COVID-19 positivity proven by reverse transcription-polymerase chain reaction (RT-PCR) testing
  4. At least one evaluation/consultation performed by a pulmonary medicine specialist OR admission to pulmonary medicine ward from another department in the hospital
  5. First hospital admission has to be via emergency ward, regardless of the concurrent hospital stay.
  6. Cooperation at an acceptable degree for pulmonary function testing.

Exclusion Criteria:

  1. Any contraindication presence for pulmonary function testing (such as anatomic abnormalities, recent cardiac history, and severe respiratory failure)
  2. Former COVID-19 history.
  3. Persistent pulmonary or other systemic pathology (which prevents hospital discharge)
  4. Refusal to participate in the monthly evaluation.
  5. Persistent COVID-19 RT-PCR presence (which prevents PFT testing)
  6. Known severe limitation in former PFT testing (FEV1 being lower than 30%)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Incentive Spirometer Group
Patients who would use an incentive spirometer, in addition to standard care provided to COVID-19 patients, will be categorized under "Incentive Spirometer Group".
Inny: Incentive Spirometer/Respiratory Exerciser
A patient is considered acceptable for the "Incentive Spirometer Group" if the patient can use an incentive spirometer and/or a respiratory exerciser at least four times per day. A pulmonary medicine specialist will confirm the proper usage of the device.
Standard Care Group
Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Peak Expiratory Flow (Absolute Value)
Ramy czasowe: The first PEF testing will be performed seven days after initial diagnosis. The second testing will be performed one month after the hospital discharge, among those who are considered suitable for testing.
Two PEF results will be compared in the study. The first PEF testing will be performed by a handheld device and the second measurement will be performed either by an office spirometer or a handheld device. The priority will be given to the office spirometer for testing preference.
The first PEF testing will be performed seven days after initial diagnosis. The second testing will be performed one month after the hospital discharge, among those who are considered suitable for testing.
Change in Peak Expiratory Flow (Percentage)
Ramy czasowe: The first PEF testing will be performed seven days after initial diagnosis. The second testing will be performed one month after the hospital discharge, among those who are considered suitable for testing.
Two PEF results will be compared in the study. The first PEF testing will be performed by a handheld device and the second measurement will be performed either by an office spirometer or a handheld device. The priority will be given to the office spirometer for testing preference.
The first PEF testing will be performed seven days after initial diagnosis. The second testing will be performed one month after the hospital discharge, among those who are considered suitable for testing.
Peak Expiratory Flow (Follow-up)
Ramy czasowe: Testing for PEF results were performed at the follow-up evaluation, which was done 1 month post-baseline.
The Peak Expiratory Flow (PEF) results were obtained at the follow-up evaluation. These results were then compared with the initial baseline measurement of PEF performed at the hospital discharge.
Testing for PEF results were performed at the follow-up evaluation, which was done 1 month post-baseline.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Forced Expiratory Volume (FEV1)
Ramy czasowe: Forced Expiratory Volume (FEV1) was evaluated at the follow-up evaluation, which was performed one-month post-baseline.
Forced Expiratory Volume (FEV1) result of the pulmonary function testing was to be used as a pulmonary function parameter. It was performed via standard office spirometry. It was calculated as an absolute value (in liters) and as a percentage (compared to the normal population data) It was to be used as a validation method to ensure patients did not have a former yet undiagnosed respiratory disease and to validate the presence of abnormal Peak Expiratory Flow (PEF) values.
Forced Expiratory Volume (FEV1) was evaluated at the follow-up evaluation, which was performed one-month post-baseline.
Forced Vital Capacity (FVC)
Ramy czasowe: Forced Vital Capacity was evaluated at the follow-up evaluation, which was performed 1 month post- baseline evaluation.
Forced Vital Capacity (FVC) result of the pulmonary function testing was to be used as a pulmonary function parameter. It was performed via standard office spirometry. It was calculated as an absolute value (in liters) and as a percentage (compared to the normal population data) It was to be used as a validation method to ensure patients did not have a former yet undiagnosed respiratory disease and to validate the presence of abnormal Peak Expiratory Flow (PEF) values.
Forced Vital Capacity was evaluated at the follow-up evaluation, which was performed 1 month post- baseline evaluation.
Mortality
Ramy czasowe: Mortality evaluation will include the time period of one month after hospital discharge. The total evaluation duration will also include the hospitalization period (which is considered an average of 7 days)
Mortality will be accepted as a secondary outcome measure, in patients who may not survive until the monthly evaluation for any reason.
Mortality evaluation will include the time period of one month after hospital discharge. The total evaluation duration will also include the hospitalization period (which is considered an average of 7 days)
Discharge to Follow-up Duration (Days)
Ramy czasowe: The time frame for "Discharge to Follow-up Duration" consisted of up to two months post-baseline evaluation. When a patient had arrived for the first follow-up evaluation, the time difference between baseline evaluation and this re-evaluation was noted.
The duration between the baseline evaluation at the time of hospital discharge and the first follow-up is defined as "Discharge to Follow-up Duration". There happens a time difference between post-one month evaluation and this definition, due to appointment dates; the exact one month time for a patient happening to be within weekend days or due to delays in respiratory testing. This could be observed by the time range of patients given here, as some (as seen in patients arriving within 13 days) had come to the hospital earlier, while some ( in the other end of the group, such as those arriving at 41st day) had either arrived late or could not be evaluated with respiratory function testing due to appointment or testing issues up to the day mentioned.
The time frame for "Discharge to Follow-up Duration" consisted of up to two months post-baseline evaluation. When a patient had arrived for the first follow-up evaluation, the time difference between baseline evaluation and this re-evaluation was noted.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Śledczy

  • Główny śledczy: Bahar Kurt, Professor, Dışkapı Yıldırım Beyazıt Training and Research Hospital Pulmonary Medicine

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 kwietnia 2021

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2021

Ukończenie studiów (Rzeczywisty)

1 lipca 2021

Daty rejestracji na studia

Pierwszy przesłany

27 marca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 marca 2021

Pierwszy wysłany (Rzeczywisty)

1 kwietnia 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

31 stycznia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 stycznia 2022

Ostatnia weryfikacja

1 stycznia 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 104/18

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

The study protocol will be shared with other researchers working on a similar process, with proper credentials and acknowledgments given according to ICJME clinical trial registration policy. Signed Informed Consent Forms will only be shared with proper legal bodies and ethical committees in case of an ethical dilemma.

Ramy czasowe udostępniania IPD

The data will be available for the 6 months after initial publication.

Kryteria dostępu do udostępniania IPD

The information mentioned above will be shared upon contact with the corresponding author. The criteria for data sharing would be that the researchers making the request would preferably seek a similar goal in the study proposal.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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