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

NCT04126785 | Recruiting

• 1 other identifier: ECDR 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Aging; Blood Pressure; Endothelial function; Exercise; Heart rate variability

Outcome Measures

Primary Outcomes (1)

• Change from baseline Blood Pressure (Systolic and Diastolic) following 12 weeks of exercise.

  Blood pressure will be assessed in resting (Omron HEM 7200®, Omron Healthcare Inc, Dalian, China) at the day of the sessions and using a 24 hour ambulatory blood pressure monitoring (Cardio-Mapa ®, Cardios System Ltda, Sao Paulo, Brazil), at the baseline and after 12 weeks of exercise.

  12 weeks

Secondary Outcomes (7)

• Effect of exercise in hemodynamic and autonomic variables assessed by endothelial function, arterial stiffness and heart rate variability

  12 weeks

• Effect of exercise in functional capacity assessed by handgrip strength test.

  12 weeks

• Effect of exercise in functional capacity assessed by 5 times sit to stand test.

  12 weeks

• Effect of exercise in functional capacity assessed by sit and reach test.

  12 weeks

• Effect of exercise in functional capacity assessed by timed up and go test.

  12 weeks

Study Arms (3)

Control without exercise in heated water-based

PLACEBO COMPARATOR

CON session will perform at controlled heated water-base (30 e 32 ºC). Subject will be seated in a chair and submerged at the xiphoid process level for 30 min.

Other: Control Group

High Intensity Interval Exercise in Heated Water

EXPERIMENTAL

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: High Intensity Interval Exercise in Heated Water-Based

Continuous Moderate Exercise in Heated Water

EXPERIMENTAL

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: Continuous Moderate Exercise in Heated Water-Based

Interventions

High Intensity Interval Exercise in Heated Water-Based OTHER

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.

Also known as: HIIT

High Intensity Interval Exercise in Heated Water

Continuous Moderate Exercise in Heated Water-Based OTHER

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.

Also known as: MICE

Continuous Moderate Exercise in Heated Water

Control Group OTHER

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.

Also known as: CON

Control without exercise in heated water-based

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

São Paulo State Univeristy

Bauru, São Paulo, 17033360, Brazil

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Ciolac EG, Bocchi EA, Bortolotto LA, Carvalho VO, Greve JM, Guimaraes GV. Effects of high-intensity aerobic interval training vs. moderate exercise on hemodynamic, metabolic and neuro-humoral abnormalities of young normotensive women at high familial risk for hypertension. Hypertens Res. 2010 Aug;33(8):836-43. doi: 10.1038/hr.2010.72. Epub 2010 May 7.

  PMID: 20448634 BACKGROUND

• Marcal IR, Ngomane AY, Souza FB, Ciolac EG. Hemodynamic response to heated water immersion in older individuals with hypertension. Blood Press Monit. 2021 Jun 1;26(3):171-175. doi: 10.1097/MBP.0000000000000504.

  PMID: 33234812 DERIVED

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Emmanuel G Ciolac, Phd

  São Paulo State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Gomes G Ciolac, Phd

CONTACT

+551431039623; emmanuel.ciolac@unesp.br

Isabela R Marçal, MSc

CONTACT

+551431039623; isabela.marcal@unesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In study 1 and 2 the participants will be aleatory randomized and the main investigator will perform the exercise session. The data will collected and assessed by a blinded investigator without knowledge of participants intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study 1 will be cross-over, randomized, controlled and single-blinded trial The study 2 will be randomized, parallel, controlled and single-blinded trial

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 15, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Initial data will be analysed at the initial sessions (cardiopulmonary exercise and functional capacity tests); at the day of sessions (study 1), after 12 weeks and 3 months of training interruption (study 2).
• Access Criteria: Informed Consent Form described and signed. DP will received Informed Consent Form informing the objectives, study deling, interventions, analyses, risks and benefits. Participation in this study will be voluntary and confidential after signing of an informed consent.

Locations

BR (1)