Hypertension Clinical Trial
Official title:
Effects of Pilates Method and Aerobic Training in Hypertensive Subjects: a Randomized Trial
| NCT number | NCT03214016 |
| Other study ID # | EPMAT |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 20, 2017 |
| Est. completion date | August 31, 2018 |
| Verified date | April 2020 |
| Source | Universidade Federal de Santa Maria |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study evaluates the effects of Pilates method and aerobic training in hypertensive subjects. Half of participants will be trained with Pilates, while the other half will be trained with aerobic exercise during 8 weeks.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | August 31, 2018 |
| Est. primary completion date | May 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - subjects with high blood pressure controled by medication; - sedentary. Exclusion Criteria: - IMC=30 kg/m² - using beta blockers - smokers or that interrupted the routine less than 6 months - musculoskeletal diseases in evolution or with current symptomatic - rheumatological diseases - other cardiovascular disease - renal disease due to hypertension - endocrine, neurological, oncological, immunological, hematological and psychiatric diseases. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | University Federal of Santa Maria | Santa Maria | RS |
| Lead Sponsor | Collaborator |
|---|---|
| Universidade Federal de Santa Maria |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline casual systolic blood pressure at 8 weeks | It will be evaluated with oscillometric method of measuring blood pressure with an automated cuff. | baseline and 8 weeks | |
| Primary | Change from baseline 24-hour systolic blood pressure at 8 weeks | It will be evaluated by 24-hour ambulatory BP monitoring (ABPM) | baseline and 8 weeks | |
| Secondary | Casual diastolic blood pressure | It will be evaluated with oscillometric method of measuring blood pressure with an automated cuff. | baseline and 8 weeks | |
| Secondary | Heart rate variability | It will be evaluated using a previously validated heart rate monitor Polar 810i, and the results will be analyzed in time- and frequency-domains. | baseline and 8 weeks | |
| Secondary | Diastolic and mean blood pressure | It will be evaluated by 24-hour ambulatory BP monitoring (ABPM) | baseline and 8 weeks | |
| Secondary | Functional capacity | Evaluate by Six-Minute Walk Test (6MWT) | baseline and 8 weeks | |
| Secondary | Respiratory muscle strength | The maximal inspiratory and expiratory pressures will be evaluated with manovacuometer | baseline and 8 weeks | |
| Secondary | Muscle strength | The muscles (quadriceps, gastrocnemius, abdominal and spine extensors) will be evaluated with dynamometer. | baseline and 8 weeks | |
| Secondary | Flexibility | It will be evaluated by bank of Wells test. | baseline and 8 weeks | |
| Secondary | Body Mass Index | It will be calculated as weight (kg) divided by height squared. | baseline and 8 weeks | |
| Secondary | Oxidative damage | It will be evaluated by advanced oxidation protein products (AOPP) | baseline and 8 weeks | |
| Secondary | Antioxidant capacity | It will be evaluated by total antioxidant capacity (TAC). | baseline and 8 weeks | |
| Secondary | Lipid profile | By blood analysis (LDL, HDL, total cholesterol, glucose and triglycerides). | baseline and 8 weeks | |
| Secondary | Endothelial function | By blood analysis (Nitrite measurement/NOx). | baseline and 8 weeks | |
| Secondary | Inflammation | It will be evaluated by C-reactive protein in blood analysis | baseline and 8 weeks | |
| Secondary | Creatinine | By blood analysis | baseline and 8 weeks | |
| Secondary | Lactate | By blood analysis | baselina and 8 weeks | |
| Secondary | Creatine kinase | By blood analysis | baseline and 8 weeks | |
| Secondary | Questionnaire of Quality of life | It will be evaluated by Mini-questionnaire of Quality of Life in Hypertension (MINICHAL) | baseline and 8 weeks |
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