HypertensionHExOLDNCT04126785
High-Intensity Interval Versus Moderate-Intensity Continuous Water Based Exercise in Hypertensive Older Individuals
A study testing High Intensity Interval Exercise in Heated Water-Based and Continuous Moderate Exercise in Heated Water-Based in people with Hypertension, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- High Intensity Interval Exercise in Heated Water-Based and Continuous Moderate Exercise in Heated Water-Based
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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;
Show all 9Show fewer
- Uncontrolled cardiovascular disease;
- Disability;
- Deficit cognitive;
Who cannot join
- Non 100% participation;
- Change (or stopped) clinical or drug treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
São Paulo State Univeristy
Bauru, São Paulo, 17033360
Emmanuel G Ciolac, Professor
About this study
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
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- High Intensity Interval Exercise in Heated Water-Based, Continuous Moderate Exercise in Heated Water-Based, Control Group
- Keywords
- Aging, Blood Pressure, Endothelial function, Exercise, Heart rate variability
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Exercise in Heated Water-BasedOther
Also called HIIT
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.
Continuous Moderate Exercise in Heated Water-BasedOther
Also called MICE
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.
Control GroupOther
Also called CON
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Continuous Moderate Exercise in Heated Water-Based |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (7)
Effect of exercise in hemodynamic and autonomic variables assessed by endothelial function, arterial stiffness and heart rate variability
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.
Measured: 12 weeks
Effect of exercise in functional capacity assessed by handgrip strength test.
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).
Measured: 12 weeks
Effect of exercise in functional capacity assessed by 5 times sit to stand test.
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.
Measured: 12 weeks
Effect of exercise in functional capacity assessed by sit and reach test.
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.
Measured: 12 weeks
Effect of exercise in functional capacity assessed by timed up and go test.
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.
Measured: 12 weeks
Effect of exercise in functional capacity assessed by 6 minutes walk test.
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.
Measured: 12 weeks
Quality of Life assessed by International Physical Activity Questionnaire
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Nov 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Emmanuel Gomes Ciolac, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Emmanuel G Ciolac, Phd, Principal investigator, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126785
- Sponsor's protocol ID
- ECDR 1
- Acronym
- HExOLD
- Status last verified
- Jul 2025
- First submitted
- 25 Sep 2019
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 18501444Ciolac 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.
PubMed 19060996Ciolac 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.
PubMed 22720199Guimaraes 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.
PubMed 30527153Ngomane 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.
PubMed 30791079Castro 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.
PubMed 26673130Ciolac 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.
PubMed 24129990Ciolac 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.
PubMed 20644524Ciolac 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.
PubMed 20448634Marcal 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.
PubMed 33234812
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04126785
- Acronym / sponsor ID
- HExOLD / ECDR 1
- Conditions
- Hypertension
- Keywords
- Aging, Blood Pressure, Endothelial function, Exercise, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Control without exercise in heated water-based | Placebo comparator | Other: Control GroupCON 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. |
| High Intensity Interval Exercise in Heated Water | Experimental | Other: High Intensity Interval Exercise in Heated Water-BasedHigh 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. |
| Continuous Moderate Exercise in Heated Water | Experimental | Other: Continuous Moderate Exercise in Heated Water-BasedContinuous 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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;
Key exclusion criteria (2 listed)
- Non 100% participation;
- Change (or stopped) clinical or drug treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Exercise in Heated Water-BasedAlso: HIITHigh 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 |
| Continuous Moderate Exercise in Heated Water-BasedAlso: MICEContinuous 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 |
| Control GroupAlso: CONCON 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 | Control without exercise in heated water-based |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Results publication: PubMed 18501444Ciolac 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.
- Results publication: PubMed 19060996Ciolac 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.
- Results publication: PubMed 22720199Ciolac 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.
- Results publication: PubMed 30527153Guimaraes 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.
- Results publication: PubMed 30791079Ngomane 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.
- Results publication: PubMed 26673130Castro 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.
- Results publication: PubMed 24129990Ciolac 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.
- Results publication: PubMed 20644524Ciolac 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.
- Results publication: PubMed 20448634Ciolac 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.
- Derived from this study: PubMed 33234812Marcal 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Hypertension
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
Not yet recruitingObservational study
Development and Validation of a Chinese Quality of Life Scale for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH), Quality of Life
RecruitingPhase 2
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, Pulmonary, Lung Diseases, Interstitial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuel G Ciolac, Phd principal investigator
São Paulo State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Exercise in Heated Water-Based and Continuous Moderate Exercise in Heated Water-Based in people with Hypertension, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Gomes G Ciolac, Phd (+551431039623, emmanuel.ciolac@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Blood Pressure (Systolic and Diastolic) following 12 weeks of exercise. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126785, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.