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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07648524
Influence of Cardiopulmonary Rehabilitation on Cardiorespiratory Adaptation in Patients With Pulmonary Hypertension
Influence of Cardiopulmonary Rehabilitation on Cardiorespiratory Adaptation in Patients With Pulmonary Hypertension: A Comparative Experimental Study
Descripción general del estudio
Estado
Descripción detallada
Pulmonary hypertension is a progressive disease associated with reduced exercise capacity, respiratory muscle weakness, and impaired quality of life. Exercise training and respiratory muscle training have been shown to improve physical performance and quality of life in patients with pulmonary hypertension.
forty-two medically stable patients with Group III pulmonary hypertension due to lung diseases (obstructive and restrictive) will participate in this comparative experimental study. Participants will receive cardiopulmonary rehabilitation consisting of moderate-intensity interval aerobic training and inspiratory muscle training in addition to routine medical treatment. Outcome measures will include echocardiographic parameters, pulmonary function, six-minute walk distance, estimated VO2max, dyspnea severity, and quality of life. The study aims to evaluate the influence of cardiopulmonary rehabilitation on cardiorespiratory adaptation in patients with pulmonary hypertension.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rana Essam El Din Abd Elbar, Assistant lecturer
- Número de teléfono: 01013981766
- Correo electrónico: rana.essam@acu.edu.eg
Ubicaciones de estudio
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Giza, Egipto
- faculty of physical therapy ,Cairo University
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Contacto:
- Rana Essam El Din Abd Elbar, Assistant lecturer
- Número de teléfono: 01013981766
- Correo electrónico: rana.essam@acu.edu.eg
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Contacto:
- Rana Essam El Din Abd Elbar, assistant lect P.T
- Correo electrónico: rana.essam@acu.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- a)Medically stable pulmonary hypertension patients who were under optimized medical therapy. b)Pulmonary artery pressure ≥ 25 mmHg confirmed by RT side heart catheterization.
c)Forty two male patients with group 3 pulmonary hypertension (Chest cause) include Obstructive lung disease ( COPD and sleep apnea ) and restrictive lung disease (ILD). d)The patients' ages will range from 45 to 65 years old. e)BMI (25 - 34.9) kg/m2. f)World Health Organization (WHO) classification of functional classes II to III ( class II are patients with pulmonary hypertension who have a mild limitation of physical activity )(class III are patients with pulmonary hypertension who have a marked limitation of physical activity
Exclusion Criteria:
g)Uncontrolled systemic HTN. h)Other types of pulmonary hypertension.. i)Smoker j)Any condition of kidney failure. k)Neurological or musculoskeletal conditions that interfere with gait
l)Impaired vision and/or hearing.
m)Patients who are unable to follow verbal instructions. n)acute exacerbation condition. o)unstable angina, serious cardiac dysrhythmias on resting ECG.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: group III PH with obstructive lung disease
Group (A), (n =16) patients with group III PH with obstructive lung disease will receive cardiopulmonary Rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment.
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Training will be conducted on a treadmill three times weekly for 12 weeks.
Exercise intensity will progress from 30-40% to 60-70% of target heart rate.
Each session will last 30 minutes and include warm-up and cool-down periods.
inspiratory muscle training will be performed using a Threshold Inspiratory Muscle Trainer (Philips Respironics).
Training intensity will correspond to moderate-to-severe effort (3-5 on the Modified Borg Scale).
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Experimental: group III PHT with restrictive lung disease
group (B), (n =16) patients with group III PHT with restrictive lung disease will receive cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment.
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Training will be conducted on a treadmill three times weekly for 12 weeks.
Exercise intensity will progress from 30-40% to 60-70% of target heart rate.
Each session will last 30 minutes and include warm-up and cool-down periods.
inspiratory muscle training will be performed using a Threshold Inspiratory Muscle Trainer (Philips Respironics).
Training intensity will correspond to moderate-to-severe effort (3-5 on the Modified Borg Scale).
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Experimental: control group III PH with obstructive lung disease
Group (c), (n =5) patients with group III PH with obstructive lung disease will receive medical treatment only
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medication
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Experimental: control group III PHT with restrictive lung disease
Group (D), (n =5) patients with group III PH with restrictive lung disease will receive medical treatment only
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medication
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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6-minute walk distance
Periodo de tiempo: 12 weeks
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total distance walked in 6 minutes
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12 weeks
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Maximal Oxygen Consumption
Periodo de tiempo: 12weeks
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Estimated VO2max
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12weeks
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spirometry
Periodo de tiempo: 12weeks
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FEV1, FVC, FEV1/FVC, MVV
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12weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dyspnea Severity
Periodo de tiempo: 12weeks
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Modified Borg Scale
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12weeks
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change Pulmonary Artery Pressure
Periodo de tiempo: 12weeks
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pulmonary artery pressure estimated by ECHO
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12weeks
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change of total score of SF-12 Questionnaire) Quality of Life
Periodo de tiempo: 12weeks
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more increase scores more increase quality of life
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12weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: NESREEN GHAREEB MOHAMED EL-NAHAS, Prof PT, faculty of P.T. Cairo University
- Silla de estudio: HEBA AHMED ALI ABDEEN, Prof, faculty of P.T. Cairo University
- Silla de estudio: HEND ABD EL-MONAEM ABD EL-MONAEM, Lecturer of physical therapy, faculty of P.T. Cairo University
- Silla de estudio: REEM IBRAHIM EL KORASHY, prof of pulmonology, Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Otros números de identificación del estudio
- P.T.REC/012/005518
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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