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BMC Public Health. 2019 May 29;19(1):657. 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.

Author information

1
Department of Public Health, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. daniel.umpierre@gmail.com.
2
National Institute of Science and Technology for Health Technology Assessment (IATS/HCPA), Hospital de Clínicas de Porto Alegre, Clinical Research Center, Rua Ramiro Barcelos 2350, Porto Alegre, RS, Brazil. daniel.umpierre@gmail.com.
3
Exercise Pathophysiology Laboratory, Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. daniel.umpierre@gmail.com.
4
Exercise Pathophysiology Laboratory, Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
5
National Institute of Science and Technology for Health Technology Assessment (IATS/HCPA), Hospital de Clínicas de Porto Alegre, Clinical Research Center, Rua Ramiro Barcelos 2350, Porto Alegre, RS, Brazil.
6
Department of Sports, Universidade Federal de Pelotas, Pelotas, RS, Brazil.
7
Department of Physiology and Pharmacology, Universidade Federal de Pelotas, Pelotas, RS, Brazil.
8
Cardiology Division, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
9
Medical School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
10
Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX, 78712, USA.
11
Department of Kinesiology, University of Connecticut, Storrs, CT, 06269-1110, USA.
12
Faculdades Integradas de Taquara, Taquara, RS, Brazil.

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; Aging; Clinical trial; Exercise; Older; Physical activity

PMID:
31142294
PMCID:
PMC6542055
DOI:
10.1186/s12889-019-6970-3
[Indexed for MEDLINE]
Free PMC Article

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