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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Physical Exercise Session in heated Swimming Pool - HEx
Other interventionWarm 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 interventionWarm 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 interventionGuidance to maintain the usual level of physical activity and not to enter physical exercise programs during the 12 weeks of follow-up.
Treatment groups
Trial outcomes
Primary outcomes
Blood pressure change
24-hour systolic and diastolic ambulatory blood pressure change from baseline
Secondary outcomes
Arterial stiffness
Carotid-femoral pulse wave velocity change from baseline
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.
Maximal oxygen consumption
Change from baseline of maximal oxygen consumption during a progressive cardiopulmonary exercise testing
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.
Other outcomes
Interleukin 6
Change from baseline of plasma levels of Interleukin 6
C-reactive protein
Change from baseline of plasma levels of C-reactive
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