Intensity Training and Cardiovascular Health in Colombian Adults (HIIT-Heart)
24 de outubro de 2016 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bogotá, Colômbia
- Robinson Ramírez Vélez Ph.D
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 45 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in LDL Cholesterol
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Robinson Ramírez Vélez, Ph.D, Universidad del Rosario
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2015
Conclusão Primária (Real)
1 de outubro de 2016
Conclusão do estudo (Real)
1 de outubro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
23 de março de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de abril de 2016
Primeira postagem (Estimativa)
14 de abril de 2016
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
25 de outubro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de outubro de 2016
Última verificação
1 de outubro de 2016
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 01-1802-2013
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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