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Home-monitoring and Adherence of Patients With COPD to Long-term Rehabilitation

14 de abril de 2015 actualizado por: Alda Sofia Pires de Dias Marques, Aveiro University

The Role of Home-monitoring in the Adherence of Patients With Chronic Obstructive Pulmonary Disease to Long-term Rehabilitation

The aim of this randomized controlled trial is to investigate the effects of adding PA monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary rehabilitation (PR) program on daily PA levels and health status of patients with COPD.

Patients will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group [EG]) or a PR program alone (control group [CG]). During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program.

It is expected that, by receiving individualized goals and a simple pedometer to self-monitor their PA during and after a PR program, patients with COPD will become more active and adhere to long-term rehabilitation, thus reducing the overall impact of COPD.

Descripción general del estudio

Descripción detallada

Patients with Chronic Obstructive Pulmonary Disease (COPD) present lower levels of physical activity (PA), which have been associated with increased healthcare utilization and reduced survival. Thus, optimizing PA levels has become one therapeutic priority in COPD management.

Pulmonary rehabilitation (PR) is an effective intervention in reducing symptoms and improving patients' functional status and quality of life. However, its effects in increasing patients' physical activity (PA) levels are limited. Previous research has suggested that PR with continuous PA monitoring with feedback may be a suitable approach to increase and maintain patients' PA levels.

Patients who agree to participate will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group [EG]) or a PR program alone (control group [CG]). Both PR programs will last 12 weeks and consist of exercise training and psychoeducation sessions. During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program.

The impact of the intervention will be explored using a mixed-methods approach.

Assessments will be conducted in both groups at 4 time points: before, immediately after, 3 and 6 months after the PR program. Physical activity levels, lung function, breathlessness, exercise tolerance, peripheral muscle strength, health-related quality of life and healthcare utilization will be assessed in both groups in these time points.

Descriptive statistics will be used to characterize the sample. To analyze changes in outcome measures, data from the two groups will be compared at each time point.

Patients in the EG will also be invited to attend focus groups after the intervention to assess their perspective about the intervention and their satisfaction with the use of the pedometer.

A sample size calculation using the primary outcome was performed based in a previous pilot study. It was found that 12 patients with COPD would be required in each group to provide 80% power (alpha = 0.05) to detect significant differences between groups. However, as PR programs usually have considerable dropouts (around 30%), 16 patients with COPD were recruited for each group.

Tipo de estudio

Intervencionista

Inscripción (Actual)

32

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Aveiro, Portugal, 3810-193
        • University of Aveiro

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
  • ≥ 18 years old
  • clinical stability for 1 month prior to the study (no hospital admissions or exacerbations)
  • able to provide their own informed consent

Exclusion Criteria:

  • inability to understand and co-operate
  • presence of severe psychiatric conditions
  • presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease
  • participation in regular strenuous exercise (e.g., greater than 10 hours per week of running, swimming, weightlifting or any other similar physical activity) prior to the study

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Grupo de control
Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychoeducation sessions (once a week).
Experimental: Grupo experimental
Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychoeducation sessions (once a week). Patients will also receive a pedometer to self-monitor their PA during and after the PR program and individualized step-count goals.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in physical activity levels
Periodo de tiempo: 1 week before, 1 week after, 3 and 6 months after the PR program
Physical activity data will be collected using a triaxial accelerometer. Number of steps per day and time spent in sedentary, light and moderate-to-vigorous intensity activities will be assessed. Time spent in different postures (i.e., standing, sitting and lying) will also be determined.
1 week before, 1 week after, 3 and 6 months after the PR program

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in exercise tolerance
Periodo de tiempo: 1 week before, 1 week after, 3 and 6 months after the PR program
Exercise tolerance will be assessed with the 6-minute walk test, following the American Thoracic Society guidelines. The maximal distance walked during 6 minutes and the associated respiratory symptoms will be collected.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in peripheral muscle strength
Periodo de tiempo: 1 week before, 1 week after, 3 and 6 months after the PR program
Isometric muscle strength of the upper and lower limbs will be assessed with the 1 repetition maximum (1-RM), following the American College of Sports Medicine guidelines.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in activities limitation resulting from breathlessness
Periodo de tiempo: 1 week before, 1 week after, 3 and 6 months after the PR program
The Modified British Medical Research Council questionnaire comprises five grades (statements) in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in behavioral regulations in exercise
Periodo de tiempo: 1 week before, 1 week after, 3 and 6 months after the PR program
The Behavioural Regulation in Exercise Questionnaire-2 (BRES-2) is a 19-item instrument designed to measure different forms of motivation for physical exercise and includes 5 sub-scales.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in general self-efficacy
Periodo de tiempo: 1 week before, 1 week after, 3 and 6 months after the PR program
The Self-Efficacy Scale is an instrument designed to measure general self-efficacy. Higher scores indicate higher self-efficacy.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in health-related quality of life
Periodo de tiempo: 1 week before, 1 week after, 3 and 6 months after the PR program
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure quality of life in patients with chronic lung disease. It has 3 domains: symptoms, activities and impact. Higher scores indicate poorer quality of life.
1 week before, 1 week after, 3 and 6 months after the PR program
Patients' perspectives about the intervention (experimental group only)
Periodo de tiempo: Immediately after the intervention
Semi-structured focus group interviews will be conducted with patients to explore the impact of the intervention (i.e., Pulmonary rehabilitation plus PA monitoring and feedback from a pedometer).
Immediately after the intervention

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in lung function
Periodo de tiempo: 1 week before, 1 week after, 3 and 6 months after the PR program
Lung function will be assessed with spirometry, according to the American Thoracic Society/European Respiratory Society guidelines.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in the number and duration of respiratory exacerbations and hospitalizations
Periodo de tiempo: 1 week before, 1 week after, 3 and 6 months after the PR program
The number and duration of respiratory exacerbations and hospitalizations will be assessed during patients' interview.
1 week before, 1 week after, 3 and 6 months after the PR program

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2014

Finalización primaria (Actual)

1 de enero de 2015

Finalización del estudio (Actual)

1 de enero de 2015

Fechas de registro del estudio

Enviado por primera vez

23 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

23 de abril de 2014

Publicado por primera vez (Estimar)

24 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de abril de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

14 de abril de 2015

Última verificación

1 de enero de 2015

Más información

Términos relacionados con este estudio

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