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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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Meta-analysis studies have demonstrated that isometric training with handgrip promotes reductions in clinical blood pressure, reaching 8 mmHg for systolic blood pressure and 4 mmHg for diastolic. However, the effects of this training modality on ambulatory blood pressure, which is better discriminant of cardiovascular risk than clinical BP, remains uncertain. Thus, the ISOPRESS Network, consists of researchers from Brazilian institutions of education and research (Federal University of Santa Catarina, Federal University of Amazonas, Federal University of Sergipe, Federal Rural University of Pernambuco and Universidade Nove de Julho), will conduct a multi-center study to analyze the effects of isometric handgrip training on clinic and 24-h ambulatory blood pressure in patients with hypertension. For this, each research center will conduct a randomized controlled trial with medicated patients with hypertension, of both sex. The participants will be randomized into two groups: isometric handgrip training group (HBT: n = 25 per center) and control group (CG: n = 25 per center).Subjects assigned to the HBT will train three times per week, four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction, during 24 weeks. Subjects randomized to the CG will perform stretching and relaxation exercises three times per week, during 24 weeks. The evaluations will occur in three moments: baseline, post-12 and post-24 weeks. The primary outcome will be ambulatory blood pressure, while clinic blood pressure and cardiac autonomic modulation will be analyzed as secondary outcomes. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be applied for within and between groups comparison. The level of significance that will be adopted is p<0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isometric handgrip training | Experimental | All participants that will be assigned to supervised isometric handgrip training will train three times per week, during 24 weeks. They will perform a bout of isometric handgrip exercise: four sets of 2-min of isometric contractions (using alternate hands) at 30% of maximal voluntary contraction. |
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| Control group | Sham Comparator | All participants randomized to control group will realize stretching and relaxation exercises, three times per week, during 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised Isometric Handgrip Training | Behavioral | The participants randomized to the experimental group will perform 24 weeks of isometric handgrip exercise training, three times/week for 16 minutes with time to rest. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ambulatory systolic blood pressure | 24h-ambulatory blood pressure monitoring | Baseline, 12 weeks 24 weeks |
| Change in ambulatory diastolic blood pressure | 24h-ambulatory blood pressure monitoring | Baseline, 12 weeks 24 weeks |
| Change in ambulatory mean blood pressure | 24h-ambulatory blood pressure monitoring | Baseline, 12 weeks 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinic systolic blood pressure | Clinic blood pressure will be checked using an automatic instrument | Baseline, 12 weeks 24 weeks |
| Change in clinic diastolic blood pressure | Clinic blood pressure will be checked using an automatic instrument |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Santa Catarina | Florianópolis | Santa Catarina | 88040-900 | Brazil | ||
| Federal University of Sergipe |
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| Sham comparator - stretching and relaxation exercises | Behavioral | The participants randomized to the control group (active comparator) will perform 24 weeks of stretching and relaxation exercise training, three times/week for 16 minutes with time to rest. |
|
| Baseline, 12 weeks 24 weeks |
| Change in clinic mean blood pressure | Clinic blood pressure will be checked using an automatic instrument | Baseline, 12 weeks 24 weeks |
| Change in heart rate variability | For heart rate variability assessment, R-R interval will be obtained using a heart rate monitor (POLAR, RS 800CX), following the recommendations of the Task Force of the European Society of Cardiology and the North American. | Baseline, 12 weeks 24 weeks |
| Aracaju |
| Brazil |
| Federal University of Amazonas | Parintins | Brazil |
| Federal Rural University of Pernambuco | Recife | Brazil |
| Universidade Nove de Julho | São Paulo | Brazil |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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