TY - JOUR
T1 - The "Hypertension Approaches in the Elderly
T2 - a Lifestyle study" multicenter, randomized trial (HAEL Study): rationale and methodological protocol
AU - The HAEL Study Group
AU - Umpierre, Daniel
AU - Santos, Lucas Porto
AU - Botton, Cíntia Ehlers
AU - Wilhelm, Eurico Nestor
AU - Helal, Lucas
AU - Schaun, Gustavo Zaccaria
AU - Ferreira, Gustavo Dias
AU - De Nardi, Angélica Trevisan
AU - Pfeifer, Lucinéia Orsolin
AU - da Silveira, Anderson Donelli
AU - Polanczyk, Carisi Anne
AU - Mendes, Graciele Ferreira
AU - Tanaka, Hirofumi
AU - Alves, Leonardo
AU - Galliano, Leony
AU - Pescatello, Linda S
AU - Brizio, Maria Laura
AU - Bock, Patrícia Martins
AU - Campelo, Paula
AU - Moraes, Ruy Silveira
AU - Domingues, Marlos Rodrigues
AU - Schaan, Beatriz D
AU - Alberton, Cristine Lima
AU - Pinto, Stephanie Santana
PY - 2019/5/29
Y1 - 2019/5/29
N2 - BACKGROUND: Hypertension is a clinical condition highly prevalent in the elderly, imposing great risks to cardiovascular diseases and loss of quality of life. Current guidelines emphasize the importance of nonpharmacological strategies as a first-line approach to lower blood pressure. Exercise is an efficient lifestyle tool that can benefit a myriad of health-related outcomes, including blood pressure control, in older adults. We herein report the protocol of the HAEL Study, which aims to evaluate the efficacy of a pragmatic combined exercise training compared with a health education program on ambulatory blood pressure and other health-related outcomes in older individuals.METHODS: Randomized, single-blinded, multicenter, two-arm, parallel, superiority trial. A total of 184 subjects (92/center), ≥60 years of age, with no recent history of cardiovascular events, will be randomized on a 1:1 ratio to 12-week interventions consisting either of a combined exercise (aerobic and strength) training, three times per week, or an active-control group receiving health education intervention, once a week. Ambulatory (primary outcome) and office blood pressures, cardiorespiratory fitness and endothelial function, together with quality of life, functional fitness and autonomic control will be measured in before and after intervention.DISCUSSION: Our conceptual hypothesis is that combined training intervention will reduce ambulatory blood pressure in comparison with health education group. Using a superiority framework, analysis plan prespecifies an intention-to-treat approach, per protocol criteria, subgroups analysis, and handling of missing data. The trial is recruiting since September 2017. Finally, this study was designed to adhere to data sharing practices.TRIAL REGISTRATION: NCT03264443 . Registered on 29 August, 2017.
AB - BACKGROUND: Hypertension is a clinical condition highly prevalent in the elderly, imposing great risks to cardiovascular diseases and loss of quality of life. Current guidelines emphasize the importance of nonpharmacological strategies as a first-line approach to lower blood pressure. Exercise is an efficient lifestyle tool that can benefit a myriad of health-related outcomes, including blood pressure control, in older adults. We herein report the protocol of the HAEL Study, which aims to evaluate the efficacy of a pragmatic combined exercise training compared with a health education program on ambulatory blood pressure and other health-related outcomes in older individuals.METHODS: Randomized, single-blinded, multicenter, two-arm, parallel, superiority trial. A total of 184 subjects (92/center), ≥60 years of age, with no recent history of cardiovascular events, will be randomized on a 1:1 ratio to 12-week interventions consisting either of a combined exercise (aerobic and strength) training, three times per week, or an active-control group receiving health education intervention, once a week. Ambulatory (primary outcome) and office blood pressures, cardiorespiratory fitness and endothelial function, together with quality of life, functional fitness and autonomic control will be measured in before and after intervention.DISCUSSION: Our conceptual hypothesis is that combined training intervention will reduce ambulatory blood pressure in comparison with health education group. Using a superiority framework, analysis plan prespecifies an intention-to-treat approach, per protocol criteria, subgroups analysis, and handling of missing data. The trial is recruiting since September 2017. Finally, this study was designed to adhere to data sharing practices.TRIAL REGISTRATION: NCT03264443 . Registered on 29 August, 2017.
KW - Aged
KW - Clinical Protocols
KW - Health Promotion/methods
KW - Humans
KW - Hypertension/prevention & control
KW - Life Style
KW - Middle Aged
U2 - 10.1186/s12889-019-6970-3
DO - 10.1186/s12889-019-6970-3
M3 - Article
C2 - 31142294
SN - 1471-2458
VL - 19
JO - BMC Public Health
JF - BMC Public Health
IS - 1
M1 - 657
ER -
