Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic response, pulmonary function and exercise capacity.
Non-pharmacological interventions are low cost and can significant enhance outcomes in these patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable therapeutic approach in patients with functional limitations, particularly those that present with difficulty to perform exercise protocols.
Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality of life of patients with PH.
Material and methods: prospective randomized controlled study with a control group (GC, n9) and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk test (6MWT) were assessed before and after the NMES protocol.
Results: the GE presented with a significant improvement in distance walked in the 6MWT, cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and social aspects of the questionnaire Short Form Health Survey-36.
Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved exercise capacity, quality of life and lung function testing.
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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Sao Paulo, Brasil, 01221-020
- Santa Casa of Sao Paulo Medical School
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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:
Males and females greater than or equal to 18 years of age, clinically stable with optimized drug therapy in the last 3 months, previously diagnosed with a mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization and who agreed to participate by signing an informed consent were included.
Exclusion Criteria:
Exclusion criteria included a diagnosis of Down syndrome, orthopedic disease or neurologic or diagnoses, history of acute heart attack, use of beta-blockers, any urgent or elective surgical intervention during the implementation of the protocol, those who used assistive devices to ambulate or develop an infectious process during the study protocol.
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 |
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Sin intervención: Control Group (GC)
The GC received standard ambulatory care, including routine exams and drug therapy.
All patients were reassessed after the 2 month protocol.
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Experimental: NMES Group (GE)
Receiving the usual care and guidance on their illness, underwent 30 minute NMES sessions twice a week for two months using an electrostimulator.
Specifically, 5 cm adhesive surface electrodes in four alternate channels on the Rectus Femoris (two channels the right and two on the left) were used to deliver two-phase symmetrical currents, with a rectangular pulse wave at a frequency of 35 Hz and pulse duration of 250 μ.
The time of ascent and descent was one second, contraction time was four seconds and relaxation was eight seconds.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Distance in six-minute walk test
Periodo de tiempo: change from baseline in distance at 2 months
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analysis of distance
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change from baseline in distance at 2 months
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Oxygen saturation in six-minute walk test
Periodo de tiempo: change from baseline in oxygen saturation at 2 months
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analysis of oxygen saturation at end of test
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change from baseline in oxygen saturation at 2 months
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Systolic blood pressure in six-minute walk test
Periodo de tiempo: change from baseline in systolic blood pressure at 2 months
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analysis of systolic blood pressure at end of test
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change from baseline in systolic blood pressure at 2 months
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Diastolic blood pressure in six-minute walk test
Periodo de tiempo: change from baseline in diastolic blood pressure at 2 months
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analysis of diastolic blood pressure at end of test
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change from baseline in diastolic blood pressure at 2 months
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Heart rate in six-minute walk test
Periodo de tiempo: change from baseline in heart rate at 2 months
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analysis of heart rate at end of test
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change from baseline in heart rate at 2 months
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Borg scale in six-minute walk test
Periodo de tiempo: change from baseline in Borg scale at 2 months
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analysis of Borg scale at end of test
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change from baseline in Borg scale at 2 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Medical Outcomes Study 36-item Short Form Health Survey
Periodo de tiempo: change from baseline at 2 months
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The questionnaire covers 36 items, designed to assess health concepts
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change from baseline at 2 months
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Forced vital capacity
Periodo de tiempo: change from baseline at 2 months
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spirometric analysis
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change from baseline at 2 months
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Forced expiratory volume in the first second
Periodo de tiempo: change from baseline at 2 months
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spirometric analysis
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change from baseline at 2 months
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Forced expiratory flow 25-75 %
Periodo de tiempo: change from baseline at 2 months
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spirometric analysis
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change from baseline at 2 months
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Ratio of forced expiratory volume in the first second and forced vital capacity
Periodo de tiempo: change from baseline at 2 months
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spirometric analysis
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change from baseline at 2 months
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Colaboradores e Investigadores
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
- Parece 517.472
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