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

NCT07131748 | Recruiting

• 1 other identifier: 2017/25648-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Aging; Exercise

Keywords

Aging; Exercise; Pathophysiology; Hypertension; Elderly; Hemodynamic Response

Outcome Measures

Primary Outcomes (1)

• Blood pressure change

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

  baseline, 3 month and 6 month

Secondary Outcomes (11)

• Arterial stiffness

  baseline, 3 month and 6 month

• Brachial artery flow-mediated dilation (FMD)

  baseline, 3 month and 6 month

• Maximal oxygen consumption

  baseline, 3 month and 6 month

• First ventilatory threshold (anaerobic threshold)

  baseline, 3 month and 6 month

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

  baseline, 3 month and 6 month

Other Outcomes (2)

• Interleukin 6

  baseline, 3 month and 6 month

• C-reactive protein

  baseline, 3 month and 6 month

Study Arms (3)

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

Interventions

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.

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

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.

HAS HEX vs HAS LEX

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.

HAS HEX vs HAS CON; HAS LEX vs HAS CON

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Universidade Estadual Paulista Julio de Mesquita Filho

Bauru, São Paulo, 17033-360, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Awassi Y. Ngomane, Master

CONTACT

+5511985678113; awassiyn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: HAS HEX vs HAS LEX HAS HEX vs HAS CON HAS LEX vs HAS CON

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: August 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

BR (1)