- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02600689
Home-Based Pulmonary Rehab for Patients With Pulmonary Fibrosis (EXPLORE-IPF)
Outpatient (phase 2) pulmonary rehab is an important, but mostly underutilized intervention to improve physical function in patients with idiopathic pulmonary fibrosis (IPF). Of those individuals who complete phase 2 pulmonary rehab, only a small cohort continues with any type of maintenance exercise therapy (phase 3). This is largely due to personal factors, such as access to transportation, weather, scheduling difficulties, and cost.
Little is known about how to enhance physical activity among patients with IPF. In addition, no studies have investigated the long-term maintenance strategies of physical training in patients with IPF. Thus, the purpose of this study is to test the feasibility and effectiveness of a home-based, pulmonary rehab program for patients with IPF. A randomized, blinded, clinical trial (RCT) design with two arms -- Wii Fit Plus exergame program and cognitive video gaming, with no active whole body movement involved - will be used to investigate the benefits of a home-based exergame program on improving pulmonary-related function and symptoms in patients with IPF.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-1212
- University of Alabama at Birmingham
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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:
- confirmed diagnosis of IPF based on the criteria of the American Thoracic Society/European Respiratory Society 2011 guidelines;
- ≥ 40 years-of-age;
- ambulatory without the use of an assistive device;
- stable clinical condition (i.e., no pulmonary exacerbation for at least 6 weeks);
- no changes in medication for at least 4 weeks before enrollment;
- currently sedentary (i.e., exercise or participate in sports less than 3 times per week for 20 min in the past 6 months) and do not play any exergames;
- report dyspnea on exertion leading to a limitation in performing daily activities (i.e., Medical Research Council (MRC) dyspnea grade >1);
- able to read and follow exercise directions in English on the television screen;
- have permission from their treating physician to participate in moderate-intensity exercise;
- able to provide informed consent by understanding the nature of study participation.
Exclusion Criteria:
- contraindication for moderate-intensity exercise (e.g., unstable cardiac disease),
- severe musculoskeletal, vestibular, or neurological disorders limiting exercise performance, or inability to perform the 6-min walk test or 15-step test,
- requires > 6 lpm supplemental oxygen therapy via nasal cannula during exercise to maintain SpO2 >88%;
- MRC dyspnea grade 4 or 5; IPF patients with MRC dyspnea grade 4 or 5 have been reported to show little or no improvement, or deteriorated following pulmonary rehab;
- stage 2 hypertension,
- anemia (hemoglobin < 8 g/dL);
- collagen vascular disease;
- obstructive lung disease,
- non-parenchymal restrictive lung disease,
- occupational lung disease (pneumoconiosis, hypersensitivity pneumonitis),
- sarcoidosis,
- other idiopathic interstitial pneumonia;
- currently participating or have participated (in the past 30 days) in another clinical trial which can affect the outcomes of the proposed study; or
- planning to move out of Alabama within the next 6 months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Physical exercise training
Combined aerobic and resistance exercise for 30 or more minutes at least 3 times per week for 12 weeks using the Wii Fit Plus
|
|
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Comparador activo: Cognitive exercise training
Cognitive, brain-training, video gaming ~30 minutes per session, 3 times per week for 12 weeks
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional performance
Periodo de tiempo: 12 weeks
|
6-min walk distance (m)
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Exercise dyspnea
Periodo de tiempo: 12 weeks
|
Dyspnea level (Borg CR10) after completing the 15-step test oximetry test
|
12 weeks
|
|
15-Step Test: Time
Periodo de tiempo: 12 weeks
|
time (sec) to complete 15-step test
|
12 weeks
|
|
15-Step Test: Exercise desaturation
Periodo de tiempo: 12 weeks
|
Level of desaturation (%) during 15-step test
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12 weeks
|
|
15-Step Test: Recovery
Periodo de tiempo: 12 weeks
|
Time to recovery to baseline oxygen saturation following 15-step test
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12 weeks
|
|
Physical activity level
Periodo de tiempo: 12 weeks
|
Time (min) spent per week in moderate-vigorous physical activity (assessed via an accelerometer)
|
12 weeks
|
|
Health-related quality of life
Periodo de tiempo: 12 weeks
|
St George's Respiratory Questionnaire
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hon K Yuen, PhD, University of Alabama at Birmingham
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Otros números de identificación del estudio
- PFF-378875
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