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NCT Number: NCT07131748

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

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.

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Key information

Conditions

Hypertension Aging Behavior Cardiovascular Diseases Exercise Motor Activity Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Physical Exercise Session in heated Swimming Pool - HEx

Other

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- LEx

Other

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- CON

Other

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

Primary outcomes

  1. Blood pressure change

    Time frame: baseline, 3 month and 6 month

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

Secondary outcomes

  1. Arterial stiffness

    Time frame: baseline, 3 month and 6 month

    Carotid-femoral pulse wave velocity change from baseline

  2. Brachial artery flow-mediated dilation (FMD)

    Time frame: baseline, 3 month and 6 month

    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.

  3. Maximal oxygen consumption

    Time frame: baseline, 3 month and 6 month

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

  4. First ventilatory threshold (anaerobic threshold)

    Time frame: baseline, 3 month and 6 month

    Change from baseline in the first ventilatory threshold (anaerobic threshold) will be measured by the V-slope method during a progressive cardiopulmonary exercise testing.

  5. Change from baseline in the second ventilatory threshold (respiratory compensation point)

    Time frame: baseline, 3 month and 6 month

    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.

  6. Exercise tolerance

    Time frame: baseline, 3 month and 6 month

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

  7. Handgrip strength

    Time frame: baseline, 3 month and 6 month

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

  8. Flexibility

    Time frame: baseline, 3 month and 6 month

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

  9. Lower-limb strength

    Time frame: baseline, 3 month and 6 month

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

  10. Agility and balance

    Time frame: baseline, 3 month and 6 month

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

  11. Endurance performance

    Time frame: baseline, 3 month and 6 month

    Six-minute walking test performance change from baseline

Other outcomes

  1. Interleukin 6

    Time frame: baseline, 3 month and 6 month

    Change from baseline of plasma levels of Interleukin 6

  2. C-reactive protein

    Time frame: baseline, 3 month and 6 month

    Change from baseline of plasma levels of C-reactive

Study contacts

Contact information is provided by the study sponsor or research team.

Awassi Y. Ngomane, Master

CONTACT

[email protected]

+5511985678113

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Acronym: HExOLD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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