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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversidade Estadual Paulista Júlio de Mesquita Filho

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical Exercise Session in heated Swimming Pool - HEx

    Other intervention

    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 intervention

    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 intervention

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: HAS HEX vs HAS LEXExperimental treatment 2 interventions
Group B: HAS HEX vs HAS CONExperimental treatment 2 interventions
Group C: HAS LEX vs HAS CONExperimental treatment 2 interventions

Trial outcomes

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

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

Sponsors and contacts

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Universidade Estadual Paulista Júlio de Mesquita Filho

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Collaborator