The “Hypertension Approaches in the Elderly: a Lifestyle study” multicenter, randomized trial (HAEL Study): rationale and methodological protocol

Umpierre, Daniel, Santos, Lucas Porto, Botton, Cíntia Ehlers, Wilhelm, Eurico N., Helal, Lucas, Schaun, Gustavo Zaccaria, Ferreira, Gustavo Dias, De Nardi, Angélica Trevisan, Pfeifer, Lucinéia Orsolin, da Silveira, Anderson Donelli, Polanczyk, Carisi Anne, Mendes, Graciele Ferreira, Tanaka, Hirofumi, Alves, Leonardo, Galliano, Leony, Pescatello, Linda S., Brizio, Maria Laura, Bock, Patrícia Martins, Campelo, Paula, Moraes, Ruy Silveira, Domingues, Marlos Rodrigues, Schaan, Beatriz D., Alberton, Cristine Lima and Pinto, Stephanie Santana (2019) The “Hypertension Approaches in the Elderly: a Lifestyle study” multicenter, randomized trial (HAEL Study): rationale and methodological protocol. BMC Public Health, 19 (1). p. 657. ISSN 1471-2458

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Abstract

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.

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