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Effect of Heated Water-Based Versus Land-Based Exercise Training on Hemodynamic Variables, Functional Capacity and Quality of Life in Older Hypertensive

Effect of Heated Water-Based Versus Land-Based Exercise Training on Hemodynamic Variables, Functional Capacity and Quality of Life in Older

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07131748
Acronym
HExOLD
Enrollment
60
Registered
2025-08-20
Start date
2025-09-01
Completion date
2027-08-30
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Exercise, Hypertension

Keywords

Aging, Exercise, Pathophysiology, Hypertension, Elderly, Hemodynamic Response

Brief 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. 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.

Interventions

OTHERPhysical Exercise Session in heated Swimming Pool - HEx

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.

OTHERPhysical Exercise Session in Land- LEx

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.

OTHERControl Session Without Exercise- CON

Guidance to maintain the usual level of physical activity and not to enter physical exercise programs during the 12 weeks of follow-up.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Universidade Estadual Paulista Júlio de Mesquita Filho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

HAS HEX vs HAS LEX HAS HEX vs HAS CON HAS LEX vs HAS CON

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure changebaseline, 3 month and 6 month24-hour systolic and diastolic ambulatory blood pressure change from baseline

Secondary

MeasureTime frameDescription
Arterial stiffnessbaseline, 3 month and 6 monthCarotid-femoral pulse wave velocity change from baseline
Brachial artery flow-mediated dilation (FMD)baseline, 3 month and 6 monthChange 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.
Maximal oxygen consumptionbaseline, 3 month and 6 monthChange from baseline of maximal oxygen consumption during a progressive cardiopulmonary exercise testing
First ventilatory threshold (anaerobic threshold)baseline, 3 month and 6 monthChange from baseline in the first ventilatory threshold (anaerobic threshold) will be measured by the V-slope method during a progressive cardiopulmonary exercise testing.
Change from baseline in the second ventilatory threshold (respiratory compensation point)baseline, 3 month and 6 monthChange 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.
Exercise tolerancebaseline, 3 month and 6 monthChange from baseline of exercie duration (minutes) during a progressive cardiopulmonary exercise testing
Agility and balancebaseline, 3 month and 6 monthChange from baseline of the timed-up and go test performance
Endurance performancebaseline, 3 month and 6 monthSix-minute walking test performance change from baseline
Handgrip strengthbaseline, 3 month and 6 monthChange from baseline of maximum isometric strength measured during handgrip strength testing (dynamometry)
Flexibilitybaseline, 3 month and 6 monthChange from baseline of the seat-and-reach test performance
Lower-limb strengthbaseline, 3 month and 6 monthChange from baseline of the five time sit-to stand performance

Other

MeasureTime frameDescription
Interleukin 6baseline, 3 month and 6 monthChange from baseline of plasma levels of Interleukin 6
C-reactive proteinbaseline, 3 month and 6 monthChange from baseline of plasma levels of C-reactive

Countries

Brazil

Contacts

Primary ContactAwassi Y. Ngomane, Master
awassiyn@gmail.com+5511985678113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026