- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02415582
Post-Exercise Hypotension in Elderly Hypertensive Men (HPE)
Effects of Different Exercises on Post-Exercise Blood Pressure in Elderly Hypertensive: A Cross-Over Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Hypertension has high prevalence and low rate of control, and is a major modifiable risk factor and public health problem. Regular physical exercise is a relevant non-pharmacological option for prevention and treatment of hypertension. Several studies demonstrated a reduction in blood pressure (BP) following different exercise protocols, and the decrease may be the result of the summation of hypotensive effects that occur in the hours following the workout. The reduction resulting from a single exercise session is called post-exercise hypotension (PEH) and has been investigated among hypertensive subjects. However, to achieve clinical relevance the PEH should reach a significant magnitude and the reduction should be sustained for a longer period.
Previous studies showed the positive effects of aerobic exercise on post-exercise hypotension in hypertensive subjects. However, there is lacking evidence regarding the effects of a single session of aerobic and resistance exercise combined, and the duration of its effect in 24 hours blood pressure in elderly hypertensive subjects.
The study is an open, crossover randomized clinical trial, with elderly men allocated to three arms, in a random order:
- Aerobic training session
- Combined resistance training and aerobic session
- Control session
After each exercise session, participants have 60 minutes for recovery, performed in the sitting position, with BP measurements every 5 minutes. In addition, participants have measured BP using 24h ambulatory BP monitoring. At the end of the trial, participants will have completed all three experimental protocols: a non-exercise control session, of sitting rest, and two exercise bouts, one of aerobic exercise and a combined resistance and aerobic exercise, with seven days of washout period among sessions. All experiments will be conducted at the same time of day to account for diurnal BP variation. Before the experimental sessions, participants are enrolled in three pre-intervention tests: a familiarization session, cardiopulmonary exercise testing and one maximum repetition strength test (1RM). The aerobic sessions last for 45 minutes, as well as the resistance exercises, and the session of control.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasil, 90035-903
- Hospital de Clínicas de Porto Alegre
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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:
- Essential hypertension grade 1 - 2 with or without medical treatment:
resting systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg
Exclusion Criteria:
- Smoking;
- Bone, joint, or muscle problems that could limit the performance of the exercises.
- BMI ≥ 30 kg/m2
- Heart Attack in the last year
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Aerobic exercise
Aerobic exercise on treadmill at 65-70% of the heart rate reserve during a session.
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Aerobic exercise on treadmill
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|
Experimental: Combined exercises
A session combines resistance and aerobic exercises, with aerobic exercise on treadmill at 65-70% of the heart rate reserve, followed by 60 minutes for cardiorespiratory recovery, and resistance exercise.
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Combined resistance and aerobic exercise
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|
Comparador falso: Control
Participants do not exercise and remain sitting for 45 minutes
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45 minutes resting sitting
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ambulatory Blood Pressure Monitoring
Periodo de tiempo: 24 hours
|
Ambulatory blood pressure monitoring following experimental protocols
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24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Office Blood Pressure
Periodo de tiempo: 1 hour
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Post exercise blood pressure during 60 minutes after experimental sessions
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1 hour
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sandra C Fuchs, PhD, Hospital de Clínicas de Porto Alegre
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
- 130484
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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