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

The HAEL Study Group; Daniel Umpierre; Lucas Porto Santos; Cíntia Ehlers Botton; Eurico Nestor Wilhelm; Lucas Helal; Gustavo Zaccaria Schaun; Gustavo Dias Ferreira; Angélica Trevisan De Nardi; Lucinéia Orsolin Pfeifer; Anderson Donelli da Silveira; Carisi Anne Polanczyk; Graciele Ferreira Mendes; Hirofumi Tanaka; Leonardo Alves; Leony Galliano; Linda S Pescatello; Maria Laura Brizio; Patrícia Martins Bock; Paula Campelo; Ruy Silveira Moraes; Marlos Rodrigues Domingues; Beatriz D Schaan; Cristine Lima Alberton; Stephanie Santana Pinto

doi:10.1186/s12889-019-6970-3

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

The HAEL Study Group, Daniel Umpierre, Lucas Porto Santos, Cíntia Ehlers Botton, Eurico Nestor Wilhelm, Lucas Helal, Gustavo Zaccaria Schaun, Gustavo Dias Ferreira, Angélica Trevisan De Nardi, Lucinéia Orsolin Pfeifer, Anderson Donelli da Silveira, Carisi Anne Polanczyk, Graciele Ferreira Mendes, Hirofumi Tanaka, Leonardo Alves, Leony Galliano, Linda S Pescatello, Maria Laura Brizio, Patrícia Martins Bock, Paula CampeloRuy Silveira Moraes, Marlos Rodrigues Domingues, Beatriz D Schaan, Cristine Lima Alberton, Stephanie Santana Pinto

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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.

Original language	English
Article number	657
Journal	BMC Public Health
Volume	19
Issue number	1
DOIs	https://doi.org/10.1186/s12889-019-6970-3
Publication status	Published - 29 May 2019
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Aged
Clinical Protocols
Health Promotion/methods
Humans
Hypertension/prevention & control
Life Style
Middle Aged

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The HAEL Study Group, Umpierre, D., Santos, L. P., Botton, C. E., Wilhelm, E. N., Helal, L., Schaun, G. Z., Ferreira, G. D., De Nardi, A. T., Pfeifer, L. O., da Silveira, A. D., Polanczyk, C. A., Mendes, G. F., Tanaka, H., Alves, L., Galliano, L., Pescatello, L. S., Brizio, M. L., Bock, P. M., ... Pinto, S. S. (2019). The "Hypertension Approaches in the Elderly: a Lifestyle study" multicenter, randomized trial (HAEL Study): rationale and methodological protocol. BMC Public Health, 19(1), Article 657. https://doi.org/10.1186/s12889-019-6970-3

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title = "The {"}Hypertension Approaches in the Elderly: a Lifestyle study{"} multicenter, randomized trial (HAEL Study): rationale and methodological protocol",

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.",

keywords = "Aged, Clinical Protocols, Health Promotion/methods, Humans, Hypertension/prevention \& control, Life Style, Middle Aged",

author = "\{The HAEL Study Group\} and Daniel Umpierre and Santos, \{Lucas Porto\} and Botton, \{C{\'i}ntia Ehlers\} and Wilhelm, \{Eurico Nestor\} and Lucas Helal and Schaun, \{Gustavo Zaccaria\} and Ferreira, \{Gustavo Dias\} and \{De Nardi\}, \{Ang{\'e}lica Trevisan\} and Pfeifer, \{Lucin{\'e}ia Orsolin\} and \{da Silveira\}, \{Anderson Donelli\} and Polanczyk, \{Carisi Anne\} and Mendes, \{Graciele Ferreira\} and Hirofumi Tanaka and Leonardo Alves and Leony Galliano and Pescatello, \{Linda S\} and Brizio, \{Maria Laura\} and Bock, \{Patr{\'i}cia Martins\} and Paula Campelo and Moraes, \{Ruy Silveira\} and Domingues, \{Marlos Rodrigues\} and Schaan, \{Beatriz D\} and Alberton, \{Cristine Lima\} and Pinto, \{Stephanie Santana\}",

year = "2019",

month = may,

day = "29",

doi = "10.1186/s12889-019-6970-3",

language = "English",

volume = "19",

journal = "BMC Public Health",

issn = "1471-2458",

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The HAEL Study Group, Umpierre, D, Santos, LP, Botton, CE, Wilhelm, EN, Helal, L, Schaun, GZ, Ferreira, GD, De Nardi, AT, Pfeifer, LO, da Silveira, AD, Polanczyk, CA, Mendes, GF, Tanaka, H, Alves, L, Galliano, L, Pescatello, LS, Brizio, ML, Bock, PM, Campelo, P, Moraes, RS, Domingues, MR, Schaan, BD, Alberton, CL & Pinto, SS 2019, 'The "Hypertension Approaches in the Elderly: a Lifestyle study" multicenter, randomized trial (HAEL Study): rationale and methodological protocol', BMC Public Health, vol. 19, no. 1, 657. https://doi.org/10.1186/s12889-019-6970-3

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

UR - https://www.scopus.com/pages/publications/85066959561

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 -

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

Abstract

UN SDGs

Keywords

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