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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAS HEX vs HAS LEX | Experimental |
| |
| HAS HEX vs HAS CON | Experimental |
| |
| HAS LEX vs HAS CON | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure change | 24-hour systolic and diastolic ambulatory blood pressure change from baseline | baseline, 3 month and 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial stiffness | Carotid-femoral pulse wave velocity change from baseline | baseline, 3 month and 6 month |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin 6 | Change from baseline of plasma levels of Interleukin 6 | baseline, 3 month and 6 month |
| C-reactive protein | Change from baseline of plasma levels of C-reactive |
Inclusion Criteria:
- For the study population, the following will not be included in the study:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Awassi Y. Ngomane, Master | Contact | +5511985678113 | awassiyn@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Estadual Paulista Julio de Mesquita Filho | Recruiting | Bauru | São Paulo | 17033-360 | Brazil |
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HAS HEX vs HAS LEX HAS HEX vs HAS CON HAS LEX vs HAS CON
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| 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. |
|
| baseline, 3 month and 6 month |
| Maximal oxygen consumption | Change from baseline of maximal oxygen consumption during a progressive cardiopulmonary exercise testing | baseline, 3 month and 6 month |
| 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. | baseline, 3 month and 6 month |
| Change from baseline in the second ventilatory threshold (respiratory compensation point) | 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. | baseline, 3 month and 6 month |
| Exercise tolerance | Change from baseline of exercie duration (minutes) during a progressive cardiopulmonary exercise testing | baseline, 3 month and 6 month |
| Handgrip strength | Change from baseline of maximum isometric strength measured during handgrip strength testing (dynamometry) | baseline, 3 month and 6 month |
| Flexibility | Change from baseline of the seat-and-reach test performance | baseline, 3 month and 6 month |
| Lower-limb strength | Change from baseline of the five time sit-to stand performance | baseline, 3 month and 6 month |
| Agility and balance | Change from baseline of the timed-up and go test performance | baseline, 3 month and 6 month |
| Endurance performance | Six-minute walking test performance change from baseline | baseline, 3 month and 6 month |
| baseline, 3 month and 6 month |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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