Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease
30 de octubre de 2016 actualizado por: Marie Carmen Valenza, Universidad de Granada
Effects of a Physiotherapy Program in Patients With Stable Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that is characterized by incompletely reversible airflow obstruction.
It is projected to be the fifth leading burden of disease worldwide by the year 2020.
Pulmonary dysfunction reduces exercise capacity in COPD patients, and it has been previously shown that COPD patients suffer deterioration in their quality of life.
The objective of this study is to examine the effects of a physical therapy intervention in stable patients with COPD.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic obstructive pulmonary disease (COPD) is one of the leading diseases causing mortality and morbidity, despite advanced pharmacotherapy and therapeutic management. Although COPD primarily affects the lungs, it also implies extrapulmonary manifestations, such as nutritional depletion, skeletal muscle dysfunction, and abnormal respiratory muscles.
Pulmonary rehabilitation is widely used to treat COPD patients and it has been shown that pulmonary rehabilitation should be implemented at all COPD stages, bringing them benefits in terms of improved exercise capacity, symptoms, and quality of life.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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
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Granada, España, 18071
- Department of Physical Therapy
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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
40 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- COPD diagnosis
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion.
Exclusion Criteria:
- Acute exacerbation in the previous month
- Contraindications of physiotherapy.
- Neurological, orthopedic or heart disease.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Experimental group
COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.
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The treatment will be based on domiciliary physiotherapy program during 8 weeks, twice a week added to standard care.
The duration of the sessions will be 45-60 minutes.
The physiotherapy treatment includes: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.
This will be a home-based program supervised by a physiotherapist.
Otros nombres:
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Otro: Control group
COPD patients with stable disease will be recruited and they will receive standard care.
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The standard care of stable COPD is based on long-acting bronchodilators (LABD).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in Muscle strength
Periodo de tiempo: Baseline, 8 weeks
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Quadriceps strength will be assessed with a portable dynamometer.
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Baseline, 8 weeks
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Changes in Exercise capacity
Periodo de tiempo: Baseline, 8 weeks
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Five times sit to stand test (5STS) will be used to assess exercise capacity, 5STS is a simple assessment tool that is feasible in all healthcare settings, and may be a rapid method of assessing changes in exercise capacity in COPD and screening for poor physical functioning individuals.
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Baseline, 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Respiratory function
Periodo de tiempo: Baseline, 8 weeks
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Spirometry is regarded as the gold standard measure of respiratory function.
Spirometry will be performed according to the American Thoracic Society (ATS) criteria.
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Baseline, 8 weeks
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Changes in Dyspnea perception
Periodo de tiempo: Baseline, 8 weeks
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Dyspnea perception will be assessed with Borg modified scale.
Patients will classify their breathlessness between 0 and 10.
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Baseline, 8 weeks
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Changes in Quality of life
Periodo de tiempo: Baseline, 8 weeks
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EuroQol-5D (EQ-5D) will be used to assess quality of life.
EQ-5D is a generic questionnaire and consists of two parts, the EQ-5D Visual analogue scale (VAS) and the EQ-5D index.
The EQ-5D VAS consists on a vertical rating scale from 0 to 100 (0 = death/worst possible health state and 100 = best possible health state).
The EQ-5D index is a five-item questionnaire (mobility, self-care, usual activity, pain/discomfort and anxiety/depression).
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Baseline, 8 weeks
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Changes in Fatigue
Periodo de tiempo: Baseline, 8 weeks
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Fatigue will be assessed with the Fatigue Severity Scale (FSS).
The FSS is a nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders.
The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them.
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Baseline, 8 weeks
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Impact of COPD
Periodo de tiempo: Baseline, 8 weeks
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The impact of COPD in patient's life will be evaluated with COPD Assessment Test (CAT) that is a simple instrument to quantify chronic obstructive pulmonary disease (COPD) impact in routine practice.
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Baseline, 8 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Quality of life related to respiratory symptoms
Periodo de tiempo: Baseline
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Saint George Respiratory Questionnaire (SGRQ) will be also used to evaluate the quality of life of patients in the previous year.
It includes 50 items, divided into three domains: Symptoms, Activity and Impacts.
A score is calculated for each domain and a total score including all items is also obtained.
Low scores indicate better health related quality of life.
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Baseline
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Peripheral vascular status
Periodo de tiempo: Baseline
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Ankle-brachial index will be used to predict the presence or absence of peripheral arterial disease.
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Baseline
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Physical activity
Periodo de tiempo: Baseline
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Modified Baecke Questionnaire will be used to assess the physical activity levels.
It is a frequently used questionnaire to measure habitual physical activity in the elderly.
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Baseline
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Cognitive status
Periodo de tiempo: Baseline
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Cognitive status will be assessed with Montreal Cognitive Assessment test (MoCA) which is a cognitive screening test designed to assist Health Professionals for detection of mild cognitive impairment.
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Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 septiembre de 2015
Finalización primaria (Actual)
1 de enero de 2016
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
2 de agosto de 2015
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2015
Publicado por primera vez (Estimar)
7 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
1 de noviembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
30 de octubre de 2016
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DF0058UG
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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