- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT05299333
Keuhkojen etäkuntoutus- ja liikuntasuositusten vertailu potilailla, joilla on post-covid-fibroosi
Keuhkojen etäkuntoutuksen tehokkuuden ja fyysistä aktiivisuutta koskevien suositusten vertailu potilailla, joilla on COVID-19:n aiheuttama keuhkofibroosi
Rehabilitation plays a very important role in the management of patients with COVID-19, focusing on respiratory and motor functions, and therefore the importance of establishing treatment strategies to ensure optimal recovery of these patients has been emphasized. It has been stated that physical activity recommendations should be clarified for the management of symptoms associated with prolonged COVID-19 Syndrome and for the continuation of activities of daily living. It has been stated that after COVID-19 pneumonia, it is necessary to evaluate the physical functions of patients with long-term follow-up and to establish rehabilitation programs. The importance of being included in the rehabilitation program was emphasized, especially for patients with lung fibrosis.
The primary aim of this study was to compare the effects of pulmonary telerehabilitation and physical activity recommendations on exercise capacity and peripheral muscle strength in patients with pulmonary fibrosis due to COVID-19.
The secondary aim of this study is to compare the effects of pulmonary telerehabilitation and physical activity recommendations on symptoms, activity and participation in patients with pulmonary fibrosis due to COVID-19.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Istanbul, Turkki (Türkiye)
- Istanbul University-Cerrahpasa
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- >18 years old
- Patients who have been infected with the COVID-19 virus at least 12 months ago and have been diagnosed with a positive PCR
- Patients with post-COVID-19 pulmonary fibrosis followed by a pulmonologist
- Patients who have sufficient technological infrastructure to participate in the telerehabilitation program and can adapt to online systems
- Patients who are clinically stable
Exclusion Criteria:
- Patients with orthopedic/neurological problems that prevent walking and exercise
- Patients with uncontrolled cardiovascular disease
- Patients with uncontrolled medical conditions
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Pulmonary Rehabilitation Group
A total of 24 sessions of breathing exercises and high-repetitive muscle endurance and strengthening exercises will be applied to the pulmonary telerehabilitation group for 8 weeks, two days a week and one day a week unsupervised, via online systems. High-repetition muscle endurance and strengthening exercises will be applied to large muscle groups of the lower and upper extremities by creating resistance with body weight and theraband. |
High repetition muscle endurance and strengthening exercises Walking |
|
Active Comparator: Physical Activity Group
Respiratory exercises and physical activity recommendations will be given to the physical activity group. Physical activity recommendations are; It will include information about the importance of physical activity and walking 3-5 days a week for at least 30 minutes of moderate intensity (4-6 on the Modified Borg scale of perceived exertion level). |
High repetition muscle endurance and strengthening exercises Walking |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Submaximal exercise capacity
Aikaikkuna: 1 week-8 week
|
Six minute walk test and |
1 week-8 week
|
|
maximal exercise capacity
Aikaikkuna: 1 week-8 week
|
Incremental shuttle walk test |
1 week-8 week
|
|
endurance exercise capacity
Aikaikkuna: 1 week-8 week
|
endurance shuttle walk test |
1 week-8 week
|
|
Peripheral muscle strength
Aikaikkuna: 1 week-8 week
|
Hand-held dynamometer |
1 week-8 week
|
|
Functional exercise capacity
Aikaikkuna: 1 week-8 week
|
1 min sit to stand test |
1 week-8 week
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Physical activity
Aikaikkuna: 1 week-8 week also Participants will monitor their weekly step counts during the study
|
Pedometer |
1 week-8 week also Participants will monitor their weekly step counts during the study
|
|
Physical activity
Aikaikkuna: 1 week-8 week
|
Physical activity will be assessed using a SenseWear Armband (BodyMedia Inc., Pittsburgh, PA, USA), worn for at least 72 hours. |
1 week-8 week
|
|
Dyspnea
Aikaikkuna: 1 week-8 week
|
Modified Medical Research Council Dyspnea Scale stratifies severity of dyspnea in respiratory diseases. The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing |
1 week-8 week
|
|
Fatigue
Aikaikkuna: 1 week-8 week
|
The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on patients. The FSS is a short questionnaire that requires to rate your level of fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. Patients read each statement and circle a number from 1 to 7, based on how accurately it reflects their condition during the past week and how much they agree or disagree that the statement applies to patients. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. Total score between 9-63. A total score of less than 36 suggests that you may not be suffering from fatigue. |
1 week-8 week
|
|
Functionality
Aikaikkuna: 1 week-8 week
|
Post covid-19 functionality scale (PCFS): The PCFS scale stratifies functional status limitation as follows: grade 0 (No functional limitations), grade 1 (Negligible functional limitations), grade 2 (Slight functional limitations), grade 3 (Moderate functional limitations), grade 4 (Severe functional limitations), and grade 5 (death) |
1 week-8 week
|
|
Emotional status
Aikaikkuna: 1 week-8 week
|
Hospital anxiety and depression scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). |
1 week-8 week
|
|
Body composition
Aikaikkuna: 1 week-8 week
|
Bioelectrical impedence analysis |
1 week-8 week
|
|
Activities of daily living
Aikaikkuna: 1 week-8 week
|
London chest activity of daily living scale: Perceived dyspnea while performing daily living activities is scored between 0-5. A high score indicates greater disability in performing ADLs. The minimum score 0 and maximum total score is 75. |
1 week-8 week
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pulmonary Telerehabilitation Feasibility
Aikaikkuna: 8 week
|
Changes in clinical status will be assessed using the 'Global Change Scale' in order to determine the programme's effect on clinical status. |
8 week
|
|
Pulmonary Telerehabilitation Feasibility
Aikaikkuna: 8 week
|
Adherence and drop-out rate |
8 week
|
|
Pulmonary Telerehabilitation Feasibility
Aikaikkuna: 8 week
|
System usability: The usability of the telerehabilitation system was assessed using the "System Usability Scale (SUS)". |
8 week
|
|
Pulmonary Telerehabilitation Feasibility
Aikaikkuna: 8 week
|
Safety |
8 week
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Hengitysteiden infektiot
- Infektiot
- RNA-virusinfektiot
- Virussairaudet
- Hengityselinten sairaudet
- Keuhkosairaudet
- Keuhkokuume, virus
- Keuhkokuume
- Koronavirusinfektiot
- Coronaviridae-infektiot
- Nidovirales-infektiot
- Keuhkosairaudet, interstitiaalinen
- Fibroosi
- Patologiset tilat, merkit ja oireet
- Käyttäytyminen
- COVID-19
- Keuhkofibroosi
- Motorinen toiminta
- Moottoritoiminta
- Liike
- Tuki- ja liikuntaelinten fysiologiset ilmiöt
- Tuki- ja hermosto- ja hermostofysiologiset ilmiöt
- Käyttää
Muut tutkimustunnusnumerot
- 2022/25
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