Effect of Isometric Handgrip Training on Ambulatory Blood Pressure: a Multi-center Study

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of hypertension, controlled by up to three antihypertensive medications

• Blood pressure levels between 130 and 180 mmHg

• No high cardiovascular risk (no other cardiovascular, metabolic or pulmonary disease nor any signals or symptoms of these disease)

• Not engaged in a physical exercise program for at least six months

• Not present cognitive impairment (Montreal Cognitive Assessment ≥ 26 points)

Locations
Other Locations
Brazil
Federal University of Sergipe
RECRUITING
Aracaju
Universidade Federal de Santa Catarina
NOT_YET_RECRUITING
Florianópolis
Federal University of Amazonas
NOT_YET_RECRUITING
Parintins
Federal Rural University of Pernambuco
RECRUITING
Recife
Universidade Nove de Julho
RECRUITING
São Paulo
Contact Information
Primary
Aline Gerage, PhD
alinegerage@yahoo.com.br
554837218554
Time Frame
Start Date: 2019-04-05
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 250
Treatments
Experimental: Isometric handgrip training
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.
Sham_comparator: Control group
All participants randomized to control group will realize stretching and relaxation exercises, three times per week, during 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Universidade Federal de Santa Catarina
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico

This content was sourced from clinicaltrials.gov