HypertensionHExOLDNCT07131748
Effect of Heated Water-Based Versus Land-Based Exercise Training on Hemodynamic Variables, Functional Capacity and Quality of Life in Older Hypertensive
A study testing Physical Exercise Session in heated Swimming Pool - HEx and Physical Exercise Session in Land- LEx in people with Hypertension and Aging, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
BACKGROUND: Physical exercise promotion is one of the main global goals of innumerous health and medical societies for preventing and managing noncommunicable chronic diseases (NCDs), being one of the main therapeutic for the patient with hypertension. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension, Aging, Exercise
- What is being tested?
- Physical Exercise Session in heated Swimming Pool - HEx and Physical Exercise Session in Land- LEx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2025to 30 Aug 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the study population, the following will not be included in the study:
- Smokers (avoiding acute effects of smoking on physiological measures);
- Individuals with decompensated cardiovascular disease, thyroid dysfunction and / or inflammatory diseases;
- Unable individuals to perform an exercise program or ergospirometric test due to physical or mental incapacity;
- Individuals with hemodynamic and / or electrocardiographic changes during the ergospirometric test.
- Only individuals older than 60 years, with a diagnosis of SAH for more than 6 months (stage 1 or 2), using antihypertensive medication (office BP less than 140/90 mmHg) and without medication change for at least 2 months.
Who cannot join
- For the study population, individuals who have less than 60% adherence to scheduled physical exercise sessions will be excluded during the study.
- Individuals who change or discontinue their clinical and / or pharmacological treatment (with or without a prescription).
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
Universidade Estadual Paulista Julio de Mesquita Filho
Bauru, São Paulo, 17033-360
Awassi Y. Ngomane, Master, +5511985678113, awassiyn@gmail.com
Emmanuel G. Ciolac, Doctor, +551114 982181511, emmanuel.ciolac@unesp.br
About this study
Official title: Effect of Heated Water-Based Versus Land-Based Exercise Training on Hemodynamic Variables, Functional Capacity and Quality of Life in Older
BACKGROUND: Physical exercise promotion is one of the main global goals of innumerous health and medical societies for preventing and managing noncommunicable chronic diseases (NCDs), being one of the main therapeutic for the patient with hypertension. Exercise in heated swimming pool has emerged as a potential alternative to physical exercise on the ground for the reduction of blood pressure (BP) of hypertensive patients, however, its effects on BP, as well as hemodynamic, metabolic, inflammatory and functional variables of older individuals with hypertension have not been investigated.
PURPOSE: To evaluate the effects of heated water-based exercise (HEx) versus land-based exercise (LEx) on BP, arterial stiffness, endothelial function, metabolic, inflammatory and functional variables of older individuals with hypertension.
METHODS: 60 older individuals (male and female) with hypertension (age > 60 years) will be randomized in 2:2:1 ratio to HEx, LEx or control (CON) intervention. The feasibility and physiological adaptations (physical capacity, musculoskeletal and cardiovascular responses to stress, biological and biochemical markers associated with the pathophysiology of the disease and vascular adaptations) will be assessed before, after 12 weeks and after 24 weeks of follow-up. HEx and LEx training programs will be performed three times per week and will be performed for the firs 12 weeks of follow-up.
- Conditions
- Hypertension, Aging, Exercise
- Being tested
- Physical Exercise Session in heated Swimming Pool - HEx, Physical Exercise Session in Land- LEx, Control Session Without Exercise- CON
- Keywords
- Aging, Exercise, Pathophysiology, Hypertension, Elderly, Hemodynamic Response
- 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.
Physical Exercise Session in heated Swimming Pool - HExOther
Warm Up - 5 minutes of stretching and heating of the joints and muscle groups to be worked; Aerobic exercise - 30 minutes of aerobic exercise (following the same control parameter of the experimental session); Resistance exercises - 20 minutes of resisted exercises, which will be divided into 6 exercises with 2 sets of 10 to 15 repetitions (following the same control parameter of the experimental session); Calm back - 5 minutes of stretching.
Physical Exercise Session in Land- LExOther
Warm up - 5 minutes of stretching and heating of the joints and muscle groups to be worked; Aerobic exercise - 30 minutes of aerobic exercise performed on treadmill and / or exercise bike (following the same control parameter of the experimental session); Endurance Exercises - 20 minutes of exercises resisted, also divided into 6 exercises with 2 sets of 10 to 15 repetitions. The large muscle groups of the upper limbs, lower limbs and trunk will be exercised in fitness machine and with free weights (following the same control parameter of the experimental session); Calm back - 5 minutes of stretching.
Control Session Without Exercise- CONOther
Guidance to maintain the usual level of physical activity and not to enter physical exercise programs during the 12 weeks of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| HAS HEX vs HAS LEX | Experimental | Not described Receives: Other: Physical Exercise Session in heated Swimming Pool - HEx; Other: Physical Exercise Session in Land- LEx |
| HAS HEX vs HAS CON | Experimental | Not described Receives: Other: Physical Exercise Session in heated Swimming Pool - HEx; Other: Control Session Without Exercise- CON |
| HAS LEX vs HAS CON | Experimental | Not described Receives: Other: Physical Exercise Session in heated Swimming Pool - HEx; Other: Control Session Without Exercise- CON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure change
24-hour systolic and diastolic ambulatory blood pressure change from baseline
Measured: baseline, 3 month and 6 month
Secondary outcomes (11)
Arterial stiffness
Carotid-femoral pulse wave velocity change from baseline
Measured: baseline, 3 month and 6 month
Brachial artery flow-mediated dilation (FMD)
Change from baseline in brachial artery flow-mediated dilation (FMD) (%), calculated as: (peak diameter - baseline diameter) / baseline diameter × 100, measured via ultrasound (SonoSite M-Turbo™) after 5-minute artery occlusion.
Measured: baseline, 3 month and 6 month
Maximal oxygen consumption
Change from baseline of maximal oxygen consumption during a progressive cardiopulmonary exercise testing
Measured: baseline, 3 month and 6 month
First ventilatory threshold (anaerobic threshold)
Change from baseline in the first ventilatory threshold (anaerobic threshold) will be measured by the V-slope method during a progressive cardiopulmonary exercise testing.
Measured: baseline, 3 month and 6 month
Change from baseline in the second ventilatory threshold (respiratory compensation point)
Change from baseline in the second ventilatory threshold (respiratory compensation point) will be determined determined as the point at which a rapid rise in ventilation/carbon dioxide output, and a fall in partial pressure of carbon dioxide output during a progressive cardiopulmonary exercise testing.
Measured: baseline, 3 month and 6 month
Exercise tolerance
Change from baseline of exercie duration (minutes) during a progressive cardiopulmonary exercise testing
Measured: baseline, 3 month and 6 month
Handgrip strength
Change from baseline of maximum isometric strength measured during handgrip strength testing (dynamometry)
Measured: baseline, 3 month and 6 month
Flexibility
Change from baseline of the seat-and-reach test performance
Measured: baseline, 3 month and 6 month
Lower-limb strength
Change from baseline of the five time sit-to stand performance
Measured: baseline, 3 month and 6 month
Agility and balance
Change from baseline of the timed-up and go test performance
Measured: baseline, 3 month and 6 month
Endurance performance
Six-minute walking test performance change from baseline
Measured: baseline, 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HAS HEX vs HAS LEX HAS HEX vs HAS CON HAS LEX vs HAS CON
- Masking
- Single blind
- Who is masked
- 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, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Emmanuel Gomes Ciolac, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131748
- Sponsor's protocol ID
- 2017/25648-4
- Other IDs
- 2017
- Acronym
- HExOLD
- Status last verified
- Aug 2025
- First submitted
- 24 Oct 2019
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heated Water-Based Versus Land-Based Exercise Training on Hemodynamic Variables, Functional Capacity and Quality of Life in Older
- ClinicalTrials.gov ID
- NCT07131748
- Acronym / sponsor ID
- HExOLD / 2017/25648-4
- Conditions
- Hypertension, Aging, Exercise
- Keywords
- Aging, Exercise, Pathophysiology, Hypertension, Elderly, Hemodynamic Response
- 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, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 20 Aug 2025 (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.
BACKGROUND: Physical exercise promotion is one of the main global goals of innumerous health and medical societies for preventing and managing noncommunicable chronic diseases (NCDs), being one of the main therapeutic for the patient with hypertension. Exercise in heated swimming pool has emerged as a potential alternative to physical exercise on the ground for the reduction of blood pressure (BP) of hypertensive patients, however, its effects on BP, as well as hemodynamic, metabolic, inflammatory and functional variables of older individuals with hypertension have not been investigated.
PURPOSE: To evaluate the effects of heated water-based exercise (HEx) versus land-based exercise (LEx) on BP, arterial stiffness, endothelial function, metabolic, inflammatory and functional variables of older individuals with hypertension.
METHODS: 60 older individuals (male and female) with hypertension (age > 60 years) will be randomized in 2:2:1 ratio to HEx, LEx or control (CON) intervention. The feasibility and physiological adaptations (physical capacity, musculoskeletal and cardiovascular responses to stress, biological and biochemical markers associated with the pathophysiology of the disease and vascular adaptations) will be assessed before, after 12 weeks and after 24 weeks of follow-up. HEx and LEx training programs will be performed three times per week and will be performed for the firs 12 weeks of follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- HAS HEX vs HAS LEX HAS HEX vs HAS CON HAS LEX vs HAS CON
| Arm | Type | Receives |
|---|---|---|
| HAS HEX vs HAS LEX | Experimental | Other: Physical Exercise Session in heated Swimming Pool - HEx, Other: Physical Exercise Session in Land- LEx |
| HAS HEX vs HAS CON | Experimental | Other: Physical Exercise Session in heated Swimming Pool - HEx, Other: Control Session Without Exercise- CON |
| HAS LEX vs HAS CON | Experimental | Other: Physical Exercise Session in heated Swimming Pool - HEx, Other: Control Session Without Exercise- CON |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For the study population, the following will not be included in the study:
- Smokers (avoiding acute effects of smoking on physiological measures);
- Individuals with decompensated cardiovascular disease, thyroid dysfunction and / or inflammatory diseases;
- Unable individuals to perform an exercise program or ergospirometric test due to physical or mental incapacity;
- Individuals with hemodynamic and / or electrocardiographic changes during the ergospirometric test.
Key exclusion criteria (2 listed)
- For the study population, individuals who have less than 60% adherence to scheduled physical exercise sessions will be excluded during the study.
- Individuals who change or discontinue their clinical and / or pharmacological treatment (with or without a prescription).
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 |
|---|---|---|
| Physical Exercise Session in heated Swimming Pool - HExWarm Up - 5 minutes of stretching and heating of the joints and muscle groups to be worked; Aerobic exercise - 30 minutes of aerobic exercise (following the same control parameter of the experimental session); Resistance exercises - 20 minutes of resisted exercises, which will be divided into 6 exercises with 2 sets of 10 to 15 repetitions (following the same control parameter of the experimental session); Calm back - 5 minutes of stretching. | Other | HAS HEX vs HAS CON, HAS HEX vs HAS LEX, HAS LEX vs HAS CON |
| Physical Exercise Session in Land- LExWarm up - 5 minutes of stretching and heating of the joints and muscle groups to be worked; Aerobic exercise - 30 minutes of aerobic exercise performed on treadmill and / or exercise bike (following the same control parameter of the experimental session); Endurance Exercises - 20 minutes of exercises resisted, also divided into 6 exercises with 2 sets of 10 to 15 repetitions. The large muscle groups of the upper limbs, lower limbs and trunk will be exercised in fitness machine and with free weights (following the same control parameter of the experimental session); Calm back - 5 minutes of stretching. | Other | HAS HEX vs HAS LEX |
| Control Session Without Exercise- CONGuidance to maintain the usual level of physical activity and not to enter physical exercise programs during the 12 weeks of follow-up. | Other | HAS HEX vs HAS CON, HAS LEX vs HAS CON |
Primary outcome
Blood pressure change
Time frame: baseline, 3 month and 6 month
24-hour systolic and diastolic ambulatory blood pressure change from baseline
11 secondary outcomes
Arterial stiffness
Time frame: baseline, 3 month and 6 month
Brachial artery flow-mediated dilation (FMD)
Time frame: baseline, 3 month and 6 month
Maximal oxygen consumption
Time frame: baseline, 3 month and 6 month
First ventilatory threshold (anaerobic threshold)
Time frame: baseline, 3 month and 6 month
Change from baseline in the second ventilatory threshold (respiratory compensation point)
Time frame: baseline, 3 month and 6 month
Exercise tolerance
Time frame: baseline, 3 month and 6 month
Handgrip strength
Time frame: baseline, 3 month and 6 month
Flexibility
Time frame: baseline, 3 month and 6 month
Lower-limb strength
Time frame: baseline, 3 month and 6 month
Agility and balance
Time frame: baseline, 3 month and 6 month
Endurance performance
Time frame: baseline, 3 month and 6 month
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 20 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise Session in heated Swimming Pool - HEx and Physical Exercise Session in Land- LEx in people with Hypertension and Aging, 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 6 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 20 Aug 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. 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 Awassi Y. Ngomane, Master (+5511985678113, awassiyn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure change (time frame: baseline, 3 month and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.