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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05299333
Comparación de Recomendaciones de Actividad Física y Telerehabilitación Pulmonar en Pacientes con Fibrosis Post Covid
Comparación de la efectividad de la telerrehabilitación pulmonar y las recomendaciones de actividad física en pacientes con fibrosis pulmonar por 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.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Istanbul, Turquía (Türkiye)
- Istanbul University-Cerrahpasa
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 |
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Comparador activo: 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Submaximal exercise capacity
Periodo de tiempo: 1 week-8 week
|
Six minute walk test and |
1 week-8 week
|
|
maximal exercise capacity
Periodo de tiempo: 1 week-8 week
|
Incremental shuttle walk test |
1 week-8 week
|
|
endurance exercise capacity
Periodo de tiempo: 1 week-8 week
|
endurance shuttle walk test |
1 week-8 week
|
|
Peripheral muscle strength
Periodo de tiempo: 1 week-8 week
|
Hand-held dynamometer |
1 week-8 week
|
|
Functional exercise capacity
Periodo de tiempo: 1 week-8 week
|
1 min sit to stand test |
1 week-8 week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical activity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 week-8 week
|
Bioelectrical impedence analysis |
1 week-8 week
|
|
Activities of daily living
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pulmonary Telerehabilitation Feasibility
Periodo de tiempo: 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
Periodo de tiempo: 8 week
|
Adherence and drop-out rate |
8 week
|
|
Pulmonary Telerehabilitation Feasibility
Periodo de tiempo: 8 week
|
System usability: The usability of the telerehabilitation system was assessed using the "System Usability Scale (SUS)". |
8 week
|
|
Pulmonary Telerehabilitation Feasibility
Periodo de tiempo: 8 week
|
Safety |
8 week
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Infecciones del Tracto Respiratorio
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neumonía Viral
- Neumonía
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Enfermedades Pulmonares Intersticiales
- Fibrosis
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- COVID-19
- Fibrosis pulmonar
- Actividad del motor
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Ejercicio
Otros números de identificación del estudio
- 2022/25
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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