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

July 22, 2025 updated by: Emmanuel Gomes Ciolac, Universidade Estadual Paulista Júlio de Mesquita Filho

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • Bauru, São Paulo, Brazil, 17033360
        • Recruiting
        • São Paulo State Univeristy
        • Contact:
          • Emmanuel G Ciolac, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control without exercise in heated water-based
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
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.
Other Names:
  • CON
Experimental: High Intensity Interval Exercise in Heated Water
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
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 Names:
  • HIIT
Experimental: Continuous Moderate Exercise in Heated Water
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
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 Names:
  • MICE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Blood Pressure (Systolic and Diastolic) following 12 weeks of exercise.
Time Frame: 12 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of exercise in hemodynamic and autonomic variables assessed by endothelial function, arterial stiffness and heart rate variability
Time Frame: 12 weeks
The arterial stiffness will be assessed by pulse wave velocity (Vicorder®, SMT Medical GmbH & Co., Wuerzburg, Germany) as well the endothelial function by Endocheck®. The heart rate variability will be measure using (Polar RS800CX®,Polar Electro Oy, Kempele, Finland) and 24 hour HOLTER monitoring (Cardio-Mapa ®, Cardios System Ltda, Sao Paulo, Brazil). All the measurements will be assessed at the pre and post moments of exercise protocol.
12 weeks
Effect of exercise in functional capacity assessed by handgrip strength test.
Time Frame: 12 weeks
The handgrip strength test will assessed using Jamar®. The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. The participant will squeeze the dynamometer with maximum isometric effort, which is maintained for about 5 seconds.The test will be performed in a single day (pre and post 12 weeks of exercise).
12 weeks
Effect of exercise in functional capacity assessed by 5 times sit to stand test.
Time Frame: 12 weeks
The 5 times sit to stand test will measure the time taken to perform 5 repetitions of rising from a standard chair without armrest (seat height of 46 cm) to a full upright position as quickly as possible and without assistance. The test will be performed in a single day (pre and post 12 weeks of exercise), following the sequence described below, and with a 3-minute rest interval between them.
12 weeks
Effect of exercise in functional capacity assessed by sit and reach test.
Time Frame: 12 weeks
The sit and reach test (Wells®) will be used to assess the posterior thigh and lower back flexibility. The test will be performed in a single day (pre and post 12 weeks of exercise), following the sequence described below, and with a 3-minute rest interval between them.
12 weeks
Effect of exercise in functional capacity assessed by timed up and go test.
Time Frame: 12 weeks
The timed up and go test will be measured measured by the time to get up from a chair without armrest (seat height of 46 cm) and without assistance, walk 3 m at normal speed, turn around, walk back and sit down. The test will be performed in a single day (pre and post 12 weeks of exercise), following the sequence described below, and with a 3-minute rest interval between them.
12 weeks
Effect of exercise in functional capacity assessed by 6 minutes walk test.
Time Frame: 12 weeks
The 6 minutes walk test will measure the distance (30 meters) that the participant can quickly walk on a flat, hard surface in a period of 6 minutes. The test will be performed in a single day (pre and post 12 weeks of exercise), following the sequence described below, and with a 3-minute rest interval between them.
12 weeks
Quality of Life assessed by International Physical Activity Questionnaire
Time Frame: 12 weeks
The International Physical Activity Questionnaire short version (validated in the Brazilian population) will be used to assess the daily physical activity level in all volunteers.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual Paulista Júlio de Mesquita Filho

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emmanuel G Ciolac, Phd, São Paulo State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECDR 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participants who has interest to participated will provide an anamnesis to investigator. The investigator will analyse the IDP eligibility or not-eligibility criteria. The eligibility participant will received a document with study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code informations. Thus, investigators will perform cardiopulmonary exercise test to confirm that IDP will be able to study protocol.

IPD Sharing 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).

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Brazil Research Ethics Committees
    Information identifier: CAAE 96882818.3.0000.5398

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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