- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05299333
Vergleich der Empfehlungen für pulmonale Telerehabilitation und körperliche Aktivität bei Patienten mit Post-Covid-Fibrose
Vergleich der Wirksamkeit von Empfehlungen zur pulmonalen Telerehabilitation und körperlicher Aktivität bei Patienten mit Lungenfibrose aufgrund von COVID-19
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
-
Istanbul, Türkei (türkiye)
- Istanbul University-Cerrahpasa
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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 |
|
Aktiver Komparator: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Submaximal exercise capacity
Zeitfenster: 1 week-8 week
|
Six minute walk test and |
1 week-8 week
|
|
maximal exercise capacity
Zeitfenster: 1 week-8 week
|
Incremental shuttle walk test |
1 week-8 week
|
|
endurance exercise capacity
Zeitfenster: 1 week-8 week
|
endurance shuttle walk test |
1 week-8 week
|
|
Peripheral muscle strength
Zeitfenster: 1 week-8 week
|
Hand-held dynamometer |
1 week-8 week
|
|
Functional exercise capacity
Zeitfenster: 1 week-8 week
|
1 min sit to stand test |
1 week-8 week
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Physical activity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 week-8 week
|
Bioelectrical impedence analysis |
1 week-8 week
|
|
Activities of daily living
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pulmonary Telerehabilitation Feasibility
Zeitfenster: 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
Zeitfenster: 8 week
|
Adherence and drop-out rate |
8 week
|
|
Pulmonary Telerehabilitation Feasibility
Zeitfenster: 8 week
|
System usability: The usability of the telerehabilitation system was assessed using the "System Usability Scale (SUS)". |
8 week
|
|
Pulmonary Telerehabilitation Feasibility
Zeitfenster: 8 week
|
Safety |
8 week
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Infektionen der Atemwege
- Infektionen
- RNA-Virusinfektionen
- Viruserkrankungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Pneumonie, viral
- Lungenentzündung
- Coronavirus-Infektionen
- Coronaviridae-Infektionen
- Nidovirales-Infektionen
- Lungenerkrankungen, Interstitial
- Fibrose
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- COVID-19
- Lungenfibrose
- Motorik
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Übung
Andere Studien-ID-Nummern
- 2022/25
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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