Intensity Training and Cardiovascular Health in Colombian Adults (HIIT-Heart)
24 de octubre de 2016 actualizado por: Robinson Ramírez-Vélez, Universidad Santo Tomas
High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health.
It has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors.
For these reasons, it is necessary to clarify which type of training, is more effective to improve cardiometabolic health in latinamerican population.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
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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Bogotá, Colombia
- Robinson Ramírez Vélez Ph.D
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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
20 años a 45 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Written informed consent.
- Interested in improving health and fitness.
Exclusion Criteria:
- Systemic infections.
- Weight loss or gain of >10% of body weight in the past 6 months for any reason.
- Currently taking medication that suppresses or stimulates appetite.
- Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
- Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
- Asthma.
- Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
- Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
- Any active use of illegal or illicit drugs.
- Current exerciser (>30 min organized exercise per week).
- Indication of unsuitability of current health for exercise protocol (PARQ).
- Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: High Intensity Interval Training
Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 300 kcal until the end of training.
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Exercise will be performed at three sessions per week.
All sessions will be supervised by a trained health or exercise professional.
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Comparador activo: Moderate Intensity Interval Training
Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training.
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Exercise will be performed at three sessions per week.
All sessions will be supervised by a trained health or exercise professional.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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FMD will be measured using the guidelines reported by Corretti et al.
The diameter of the brachial artery will be assessed using a high-resolution ultrasound device (Siemens SG-60, USA), equipped with a 7.5 MHz linear array transducer
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from Baseline in LDL Cholesterol
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in HDL Cholesterol
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Triglycerides
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Glucose
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Heart rate variability
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Aortic pulse wave velocity (PWVao)
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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PWVao (m s-1) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph.
The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured PWVao values was less than 1.1 m/sec).
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in muscular fitness
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Muscular fitness (MF) will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III®
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Flexibility using the sit and reach test
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in peak uptake of volume of oxygen
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Blood Pressure
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Body Mass Index
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Body Mass
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
Periodo de tiempo: Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Augmentation index (AIx)
Periodo de tiempo: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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AIx (%) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph.
The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured AIx values was less than 1.1 m/sec).
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Robinson Ramírez Vélez, Ph.D, Universidad del Rosario
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Effect of Moderate- Versus High-Intensity Interval Exercise Training on Heart Rate Variability Parameters in Inactive Latin-American Adults: A Randomized Clinical Trial. J Strength Cond Res. 2020 Dec;34(12):3403-3415. doi: 10.1519/JSC.0000000000001833.
- Ramirez-Velez R, Hernandez-Quinones PA, Tordecilla-Sanders A, Alvarez C, Ramirez-Campillo R, Izquierdo M, Correa-Bautista JE, Garcia-Hermoso A, Garcia RG. Effectiveness of HIIT compared to moderate continuous training in improving vascular parameters in inactive adults. Lipids Health Dis. 2019 Feb 4;18(1):42. doi: 10.1186/s12944-019-0981-z.
- Ramirez-Velez R, Correa-Rodriguez M, Tordecilla-Sanders A, Aya-Aldana V, Izquierdo M, Correa-Bautista JE, Alvarez C, Garcia-Hermoso A. Exercise and postprandial lipemia: effects on vascular health in inactive adults. Lipids Health Dis. 2018 Apr 3;17(1):69. doi: 10.1186/s12944-018-0719-3.
- Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Similar cardiometabolic effects of high- and moderate-intensity training among apparently healthy inactive adults: a randomized clinical trial. J Transl Med. 2017 May 30;15(1):118. doi: 10.1186/s12967-017-1216-6. Erratum In: J Transl Med. 2017 Jun 13;15(1):136.
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 junio de 2015
Finalización primaria (Actual)
1 de octubre de 2016
Finalización del estudio (Actual)
1 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
23 de marzo de 2016
Primero enviado que cumplió con los criterios de control de calidad
8 de abril de 2016
Publicado por primera vez (Estimar)
14 de abril de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
25 de octubre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
24 de octubre de 2016
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01-1802-2013
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .