- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02509299
Effect of Physiotherapy in Hospitalized COPD Patients
Effect of Different Physiotherapy Treatments in Hospitalized COPD Patients
Chronic obstructive pulmonary disease (COPD) impacts negatively on the balance and strength of patients. Several studies have shown that acute exacerbations (AEs) decrease, pulmonary function and survival of COPD patients, and there are a lot of physiotherapy interventions to improve it during the hospital stay.
The objective of the present study is to examine the effects of a physical therapy program on balance and strength in COPD patients hospitalized due to acute exacerbation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. It is a progressive disease, characterized by lung function impairment with airway obstruction.
Patients with COPD suffer exacerbations; the frequency of these exacerbations increases with the severity of the disease. It has been previously shown that the level of health-related quality of life of COPD subjects deteriorates considerably with increasing severity of disease and that the deterioration is linearly related to a decrease in FEV1 % predicted normal values.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Granada, España, 18071
- Department of Physical Therapy
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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:
- COPD diagnosis with exacerbation.
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion.
Exclusion Criteria:
- Contraindications for physiotherapy
- Neurological, orthopedic or heart disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Experimental group 1
patients will be involved in the Physiotherapy program 1.
The program included 15 minutes of deep breathing exercises and 20-30 minutes of limb exercises.
The exercises included global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises added to standard treatment.
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The standard medical treatment and additionally they will receive physiotherapy.
The program will be performed every day during the hospital stay and it will include global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises.
Otros nombres:
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Experimental: Experimental group 2
patients will be involved in the physiotherapy program 2. The program was a combined intervention including the Control Group treatment plus neuromuscular stimulation therapy on quadriceps accompanied by lower limb exercises.
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COPD patients included in this group will receive the standard medical treatment and additionally, they will receive a physiotherapy program.
The program will be performed every day during the hospital stay and included neuromuscular stimulation therapy on quadriceps accompanied by lower limbs exercises
Otros nombres:
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Otro: Control group
patients will receive standard medical treatment without physiotherapy intervention.
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The standard medical treatment consists on:
Inhaled glucocorticoids including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate and triamcinolone acetonide, depending on the expert criteria. - Antibiotics: The antibiotics were administered according to the GOLD criteria including the β-lactamase inhibitor and fluoroquinolones.
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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Lower limb strength
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Lower limb strength was evaluated by a dynamometer.
The assessor placed the limb to be examined in the starting position (a knee flexion of 90º) and instructed each participant to hold the limb in that position against the increasing resistance applied to it by the examiner.
During each test the assessor counted out loud for seconds and at the end of the test period advised the participant to relax the limb.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Balance
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Balance was evaluated by the one-leg standing balance test, that measured the time that the patient balance on one leg as long as possible.
We asked the subject being tested to choose a leg to stand on (whichever he felt more comfortable with), flex the opposite knee allowing the foot to clear the floor, and balance on one leg as long as possible
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Respiratory function
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Spirometry is regarded as the gold standard measure of respiratory function.
The indicators of forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) will be tested.
Spirometry will be performed according to American Thoracic Society (ATS) criteria.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Anxiety and depression
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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The hospital anxiety and depression scale (HADS) will be used to evaluate psychological status.
HADS is a 14-items self-report questionnaire designed to detect psychological morbidity in medically ill patients.
It contains depression and anxiety subscales, each with scores ranging from 0 to 21.
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Participants will be followed for the duration of hospital stay, an expected average of 9 days.
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Colaboradores e Investigadores
Patrocinador
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 (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
Plan de datos de participantes individuales (IPD)
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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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