High-Intensity Interval Versus Moderate-Intensity Continuous Water Based Exercise in Hypertensive Older Individuals

Official title

Effects of High-Intensity Interval Versus Moderate-Intensity Continuous Heated Water-Based Exercise on Blood Pressure and Hemodynamic Variables in Older Individuals With Hypertension

Overview

This study will investigate the acute and chronic effects in hemodynamic and autonomic variables to high-intensity interval versus moderate-intensity continuous heated water-based exercise in older individuals with hypertension.

Detailed description

BACKGROUND: Population aging is an unprecedented worldwide reality, which results in a change of epidemiological profile and increased prevalence of age-related non-communicable chronic diseases (NCDs). Among age-related NCDs, systemic arterial hypertension (HPT) is the leading cause of mortality and disability worldwide and has increased prevalence, morbidity and mortality with advancing age. Increase in physical activity level through regular physical exercise is one of the main global goals for the prevention and treatment of HPT and others NCDs. Among the different exercise types and intensities, high intensity interval exercise (HIIT) showed superior benefits for reducing blood pressure (BP) and improving variables involved in the pathophysiology of HPT when compared to continuous moderate-intensity exercise (MICE). However individuals with comorbidities or injures are not capable to follow adequate intensity of both types of exercise. Heated water-based has been used as an option to facilitate the individuals adherence to exercise and positive results especially in BP levels. Despite this, little is known about the effect of HIIT or MICE in heated water-based on BP and other hemodynamic variables involved in the pathophysiology of HPT in older hypertensive individuals. PURPOSE: To evaluate the hemodynamic and autonomic response to a HIIT versus MICE session and in 12 weeks of training in older individuals with hypertension. METHODS: 60 elderly hypertensives of both genders, aged over 60 years, will be randomized in the ratio 2: 2: 1 to 12 weeks of high intensity interval training (HIIT), moderate intensity continuous (MICE) or control follow-up without exercise (CON), respectively. Exercise programs will be discontinued after 12 weeks, and individuals will be followed up for another 12 weeks. Individuals will have their physical (cardiorespiratory and muscular) and functional capacity (walking, sitting and lifting ability), hemodynamic variables (blood pressure, arterial stiffness, endothelial function and cardiovascular response to exercise) and autonomic variables (variability of heart rate) and quality of life assessed before and after 12 and 24 weeks of follow-up. Before the beginning of the follow-up, 20 elderly hypertensive patients will also have a hemodynamic response (ambulatory blood pressure, endothelial function, arterial stiffness) and autonomic (heart rate variability) to a session of HI-HEx, MI-HEx and CON evaluated and compared. The feasibility of HIIE and MICE will also be assessed over the 12 weeks of its implementation. HIIT will consisted of warm up (4 min), 21 min of 1 min high intensity exercise (level 15) and "very hard" (level 17) of the subjective Rating of Perceived Exertion Scale (RPE) alternating with 2 min of walking at intensity between "easy" (level 9) and "fairly easy" (level 11) of the RPE. MICE will performed of 4 min warm up and 26 min of walking or jogging at intensity between "fairly light" (level 11) and " somewhat hard " (level 13) of the RPE.

Interventions

• Other High Intensity Interval Exercise in Heated Water-Based
  High intensity interval exercise will perform at controlled heated water-base (30 e 32 ºC). Subject will be submerged at the xiphoid process level. The session will consist in 4 min walking (warm-up) at 9 level of rate perceived exertion (RPE) scale, followed by 21 min of HIIE, alternating 1 min of jogging/running at 15-17 (hard-very hard) level with 2 min of walking at 9-11 (very light-fairly light) level of RPE.
• Other Continuous Moderate Exercise in Heated Water-Based
  Continuous moderate exercise will perform at controlled heated water-base (30 e 32 ºC). Subject will be submerged at the xiphoid process level. The session will consist in 4 min walking (warm-up) at 9 level (light) of RPE, followed by 26 min of MICE, walking at 11-13 (fairly light)level of RPE.
• Other Control Group
  CON session will perform at controlled heated water-base (30 e 32 ºC). Subject will be seated in a chair and submerged at the until xiphoid process level for 30 min.

Primary outcome measures

• Change from baseline Blood Pressure (Systolic and Diastolic) following 12 weeks of exercise. [Time frame: 12 weeks]

Secondary outcome measures (7)

• Effect of exercise in hemodynamic and autonomic variables assessed by endothelial function, arterial stiffness and heart rate variability [Time frame: 12 weeks]
• Effect of exercise in functional capacity assessed by handgrip strength test. [Time frame: 12 weeks]
• Effect of exercise in functional capacity assessed by 5 times sit to stand test. [Time frame: 12 weeks]
• Effect of exercise in functional capacity assessed by sit and reach test. [Time frame: 12 weeks]
• Effect of exercise in functional capacity assessed by timed up and go test. [Time frame: 12 weeks]
• Effect of exercise in functional capacity assessed by 6 minutes walk test. [Time frame: 12 weeks]
• Quality of Life assessed by International Physical Activity Questionnaire [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• ≥60 years old;
• Hypertension diagnosed at least 6 months earlier (stage 1 or 2);
• Antihypertensive drug treatment and without dosage alteration at least 3 months earlier;
• Blood pressure inferior to 140/90 mmHg in medical office.

Non-inclusion criteria:

• Smoking individuals;
• Uncontrolled cardiovascular disease;
• Disability;
• Deficit cognitive;

Exclusion criteria

• Non 100% participation;
• Change (or stopped) clinical or drug treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• São Paulo State Univeristy — Bauru

Publications

• Ciolac EG, Guimaraes GV, D Avila VM, Bortolotto LA, Doria EL, Bocchi EA. Acute effects of continuous and interval aerobic exercise on 24-h ambulatory blood pressure in long-term treated hypertensive patients. Int J Cardiol. 2009 Apr 17;133(3):381-7. doi: 10.1016/j.ijcard.2008.02.005. Epub 2008 May 22. PMID 18501444
• Ciolac EG, Guimaraes GV, D'Avila VM, Bortolotto LA, Doria EL, Bocchi EA. Acute aerobic exercise reduces 24-h ambulatory blood pressure levels in long-term-treated hypertensive patients. Clinics (Sao Paulo). 2008 Dec;63(6):753-8. doi: 10.1590/s1807-59322008000600008. PMID 19060996
• Ciolac EG. High-intensity interval training and hypertension: maximizing the benefits of exercise? Am J Cardiovasc Dis. 2012;2(2):102-10. Epub 2012 May 15. PMID 22720199
• Guimaraes GV, Fernandes-Silva MM, Drager LF, de Barros Cruz LG, Castro RE, Ciolac EG, Bocchi EA. Hypotensive Effect of Heated Water-Based Exercise Persists After 12-Week Cessation of Training in Patients With Resistant Hypertension. Can J Cardiol. 2018 Dec;34(12):1641-1647. doi: 10.1016/j.cjca.2018.09.013. Epub 2018 Oct 5. PMID 30527153
• Ngomane AY, Fernandes B, Guimaraes GV, Ciolac EG. Hypotensive Effect of Heated Water-based Exercise in Older Individuals with Hypertension. Int J Sports Med. 2019 Apr;40(4):283-291. doi: 10.1055/a-0828-8017. Epub 2019 Feb 21. PMID 30791079
• Castro RE, Guimaraes GV, Da Silva JM, Bocchi EA, Ciolac EG. Postexercise Hypotension after Heart Transplant: Water- versus Land-Based Exercise. Med Sci Sports Exerc. 2016 May;48(5):804-10. doi: 10.1249/MSS.0000000000000846. PMID 26673130
• Ciolac EG, Roberts CK, da Silva JM, Guimaraes GV. Age affects exercise-induced improvements in heart rate response to exercise. Int J Sports Med. 2014 May;35(5):371-8. doi: 10.1055/s-0033-1351332. Epub 2013 Oct 15. PMID 24129990
• Ciolac EG, Carvalho VO, Guimaraes GV. High-intensity interval vs. moderate steady-state exercise. Am J Hypertens. 2010 Aug;23(8):812; author reply 813. doi: 10.1038/ajh.2010.108. No abstract available. PMID 20644524

Identifiers

NCT: NCT04126785 · ECDR 1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗