High-intensity interval training vs. hydrochlorothiazide on blood pressure, cardiovascular health and cognition: Protocol of a non-inferiority trial.


Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
03 2021
Historique:
received: 21 10 2020
revised: 05 01 2021
accepted: 15 01 2021
pubmed: 24 1 2021
medline: 25 9 2021
entrez: 23 1 2021
Statut: ppublish

Résumé

While the number of people with hypertension (HBP) continues to increase, the therapeutic target for optimal blood pressure (BP) has been revised to a lower level. Studies have suggested that High-Intensity Interval Training (HIIT) could be as efficient as BP-lowering drugs, but no study has compared their efficacy in a randomized trial. The aim of this protocol is to determine if HIIT is as efficient as Hydrochlorothiazide (HCTZ) in lowering 24 h ambulatory BP in prehypertensive older adults. Moreover, the secondary aim is to determine if HIIT is associated with greater cardiovascular and cognitive benefits than HCTZ. This study is an interventional, single-center, non-inferiority trial, with two randomized parallel groups of prehypertensive participants aged 60 years or more. One group will be prescribed daily doses of 12.5 mg of HCTZ for 12 weeks, and the other group will follow thrice-weekly HIIT for 12 weeks. Each group will be composed of 30 participants. The primary outcome is 24 h ambulatory BP. Secondary outcomes are scores on neuropsychological assessments, balance and gait performances, maximal oxygen uptake, peripheral endothelial function, and arterial stiffness. Non-inferiority tests will be performed on the primary outcome, and secondary outcomes will be compared using independent t-tests. This study will determine if HIIT is at least as efficient as HCTZ in lowering BP in prehypertensive older adults. This study will also determine if HIIT provides greater benefits in terms of cardiovascular and cognitive status (NCT04103411).

Sections du résumé

BACKGROUND
While the number of people with hypertension (HBP) continues to increase, the therapeutic target for optimal blood pressure (BP) has been revised to a lower level. Studies have suggested that High-Intensity Interval Training (HIIT) could be as efficient as BP-lowering drugs, but no study has compared their efficacy in a randomized trial. The aim of this protocol is to determine if HIIT is as efficient as Hydrochlorothiazide (HCTZ) in lowering 24 h ambulatory BP in prehypertensive older adults. Moreover, the secondary aim is to determine if HIIT is associated with greater cardiovascular and cognitive benefits than HCTZ.
METHODS
This study is an interventional, single-center, non-inferiority trial, with two randomized parallel groups of prehypertensive participants aged 60 years or more. One group will be prescribed daily doses of 12.5 mg of HCTZ for 12 weeks, and the other group will follow thrice-weekly HIIT for 12 weeks. Each group will be composed of 30 participants. The primary outcome is 24 h ambulatory BP. Secondary outcomes are scores on neuropsychological assessments, balance and gait performances, maximal oxygen uptake, peripheral endothelial function, and arterial stiffness. Non-inferiority tests will be performed on the primary outcome, and secondary outcomes will be compared using independent t-tests.
CONCLUSION
This study will determine if HIIT is at least as efficient as HCTZ in lowering BP in prehypertensive older adults. This study will also determine if HIIT provides greater benefits in terms of cardiovascular and cognitive status (NCT04103411).

Identifiants

pubmed: 33484896
pii: S1551-7144(21)00022-7
doi: 10.1016/j.cct.2021.106286
pii:
doi:

Substances chimiques

Antihypertensive Agents 0
Hydrochlorothiazide 0J48LPH2TH

Banques de données

ClinicalTrials.gov
['NCT04103411']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

106286

Informations de copyright

Copyright © 2021 Elsevier Inc. All rights reserved.

Auteurs

Antoine Langeard (A)

Department of Medicine, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada; Research Center, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada. Electronic address: antoine.langeard@unicaen.fr.

Simon-Olivier Cloutier (SO)

Department of Psychology, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada.

Miloudza Olmand (M)

Department of Psychology, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada.

Kathia Saillant (K)

Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada; Department of Psychology, Université du Québec à Montréal, Montréal, Québec, Canada.

Christine Gagnon (C)

Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada.

Catherine-Alexandra Grégoire (CA)

Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada.

Annick Fortier (A)

Montreal Health Innovations Coordinating Center (MHICC), Canada.

Martine Lacroix (M)

Research Center, Montreal Heart Institute, Montréal, Québec, Canada.

Julie Lalongé (J)

Preventive Medicine and Physical Activity Center (centre EPIC), Canada.

Mathieu Gayda (M)

Preventive Medicine and Physical Activity Center (centre EPIC), Canada.

Florent Besnier (F)

Department of Medicine, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada.

Daniel Gagnon (D)

Department of Kinesiology and Exercise Science, Université de Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada.

Louis Bherer (L)

Department of Medicine, Université de Montréal, Montréal, Québec, Canada; Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada; Research Center, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada. Electronic address: louis.bherer@umontreal.ca.

Anil Nigam (A)

Preventive Medicine and Physical Activity Center (centre EPIC), Canada; Research Center, Montreal Heart Institute, Montréal, Québec, Canada.

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Classifications MeSH