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RecruitingNCT07131748HExOLDUpdated Aug 20, 2025

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

An interventional study of Physical Exercise Session in heated Swimming Pool - HEx and Physical Exercise Session in Land- LEx in Hypertension, Aging and Exercise, sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Recruiting at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension
  • Aging
  • Exercise

Keywords

  • Aging
  • Exercise
  • Pathophysiology
  • Hypertension
  • Elderly
  • Hemodynamic Response
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho is the lead sponsor of 82 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    HAS HEX vs HAS LEX

    Other: Physical Exercise Session in heated Swimming Pool - HEx · Other: Physical Exercise Session in Land- LEx

  • Experimental
    HAS HEX vs HAS CON

    Other: Physical Exercise Session in heated Swimming Pool - HEx · Other: Control Session Without Exercise- CON

  • Experimental
    HAS LEX vs HAS CON

    Other: Physical Exercise Session in heated Swimming Pool - HEx · Other: Control Session Without Exercise- CON

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.

06

What researchers measure

Primary outcomes

  1. Blood pressure change

    24-hour systolic and diastolic ambulatory blood pressure change from baseline

    Time frame: baseline, 3 month and 6 month

Secondary outcomes

  1. Arterial stiffness

    Carotid-femoral pulse wave velocity change from baseline

    Time frame: baseline, 3 month and 6 month

  2. 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.

    Time frame: baseline, 3 month and 6 month

  3. Maximal oxygen consumption

    Change from baseline of maximal oxygen consumption during a progressive cardiopulmonary exercise testing

    Time frame: baseline, 3 month and 6 month

  4. 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.

    Time frame: baseline, 3 month and 6 month

  5. 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.

    Time frame: baseline, 3 month and 6 month

  6. Exercise tolerance

    Change from baseline of exercie duration (minutes) during a progressive cardiopulmonary exercise testing

    Time frame: baseline, 3 month and 6 month

  7. Handgrip strength

    Change from baseline of maximum isometric strength measured during handgrip strength testing (dynamometry)

    Time frame: baseline, 3 month and 6 month

  8. Flexibility

    Change from baseline of the seat-and-reach test performance

    Time frame: baseline, 3 month and 6 month

  9. Lower-limb strength

    Change from baseline of the five time sit-to stand performance

    Time frame: baseline, 3 month and 6 month

  10. Agility and balance

    Change from baseline of the timed-up and go test performance

    Time frame: baseline, 3 month and 6 month

  11. Endurance performance

    Six-minute walking test performance change from baseline

    Time frame: baseline, 3 month and 6 month

Other outcomes

  1. Interleukin 6

    Change from baseline of plasma levels of Interleukin 6

    Time frame: baseline, 3 month and 6 month

  2. C-reactive protein

    Change from baseline of plasma levels of C-reactive

    Time frame: baseline, 3 month and 6 month

07

Study locations

1 of 1 sites recruiting
  • Universidade Estadual Paulista Julio de Mesquita Filho
    Bauru, São Paulo 17033-360, Brazil
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07131748
Lead sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Responsible party
Emmanuel Gomes Ciolac (Associate Professor, Universidade Estadual Paulista Júlio de Mesquita Filho) — Principal investigator
First posted
Aug 20, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Aug 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Aug 20, 2025

Study contacts

Awassi Y. Ngomane, Master
Contact
awassiyn@gmail.com
+5511985678113

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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