Clinical trial NCT03896334: Effect of Isometric Handgrip Training on Ambulatory Blood Pressure in Patients With Hypertension
Official title: Effect of Isometric Handgrip Training on Ambulatory Blood Pressure: a Multi-center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-03-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Adherence to less than 85% of training sessions
* Diagnosis of other cardiovascular diseases or diabetes during the course of the study
* Adherence to another supervised physical exercise program
* Change in medication class and/ or dose during the study
* Aggravation of the disease (i.e. blood pressure above 180 or use of four or more medications).

Primary outcomes:
measure: Change in ambulatory systolic blood pressure
timeFrame: Baseline, 12 weeks 24 weeks
measure: Change in ambulatory diastolic blood pressure
timeFrame: Baseline, 12 weeks 24 weeks
measure: Change in ambulatory mean blood pressure
timeFrame: Baseline, 12 weeks 24 weeks
Secondary outcomes:
measure: Change in clinic systolic blood pressure
timeFrame: Baseline, 12 weeks 24 weeks
measure: Change in clinic diastolic blood pressure
timeFrame: Baseline, 12 weeks 24 weeks
measure: Change in clinic mean blood pressure
timeFrame: Baseline, 12 weeks 24 weeks
measure: Change in heart rate variability
timeFrame: Baseline, 12 weeks 24 weeks
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Universidade Federal de Santa Catarina
state: Santa Catarina
city: Aracaju
country: Brazil
facility: Federal University of Sergipe
city: Parintins
country: Brazil
facility: Federal University of Amazonas
city: Recife
country: Brazil
facility: Federal Rural University of Pernambuco
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
Study officials:
References: