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

NCT ID: NCT07131748

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Aging Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

HAS HEX vs HAS LEX HAS HEX vs HAS CON HAS LEX vs HAS CON
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HAS HEX vs HAS LEX

Group Type EXPERIMENTAL

Physical Exercise Session in heated Swimming Pool - HEx

Intervention Type 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

Intervention Type 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.

HAS HEX vs HAS CON

Group Type EXPERIMENTAL

Physical Exercise Session in heated Swimming Pool - HEx

Intervention Type 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.

Control Session Without Exercise- CON

Intervention Type OTHER

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

HAS LEX vs HAS CON

Group Type EXPERIMENTAL

Physical Exercise Session in heated Swimming Pool - HEx

Intervention Type 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.

Control Session Without Exercise- CON

Intervention Type OTHER

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

Interventions

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Physical 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.

Intervention Type OTHER

Physical 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.

Intervention Type OTHER

Control 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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role lead

Responsible Party

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Emmanuel Gomes Ciolac

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Estadual Paulista Julio de Mesquita Filho

Bauru, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Awassi Y. Ngomane, Master

Role: CONTACT

+5511985678113

Facility Contacts

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Awassi Y. Ngomane, Master

Role: primary

+5511985678113

Emmanuel G. Ciolac, Doctor

Role: backup

+551114 982181511

Other Identifiers

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2017/25648-4

Identifier Type: -

Identifier Source: org_study_id

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