Effect of Isometric Handgrip Training on Ambulatory Blood Pressure in Patients With Hypertension

Hypertension Clinical Trial

— ISOPRESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03896334
• Other study ID #: ISOPRESS_MULTICENTER STUDY
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2019
• Est. completion date: December 15, 2024

Study information

• Verified date: May 2024
• Source: Universidade Federal de Santa Catarina
• Contact: Aline Gerage, PhD
• Phone: 554837218554
• Email: alinegerage[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Supervised Isometric Handgrip Training
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.
• Sham comparator - stretching and relaxation exercises
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.

Locations

Country	Name	City	State
Brazil	Federal University of Sergipe	Aracaju
Brazil	Universidade Federal de Santa Catarina	Florianopolis	Santa Catarina
Brazil	Federal University of Amazonas	Parintins
Brazil	Federal Rural University of Pernambuco	Recife
Brazil	Universidade Nove de Julho	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Santa Catarina	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ambulatory systolic blood pressure	24h-ambulatory blood pressure monitoring	Baseline, 12 weeks 24 weeks
Primary	Change in ambulatory diastolic blood pressure	24h-ambulatory blood pressure monitoring	Baseline, 12 weeks 24 weeks
Primary	Change in ambulatory mean blood pressure	24h-ambulatory blood pressure monitoring	Baseline, 12 weeks 24 weeks
Secondary	Change in clinic systolic blood pressure	Clinic blood pressure will be checked using an automatic instrument	Baseline, 12 weeks 24 weeks
Secondary	Change in clinic diastolic blood pressure	Clinic blood pressure will be checked using an automatic instrument	Baseline, 12 weeks 24 weeks
Secondary	Change in clinic mean blood pressure	Clinic blood pressure will be checked using an automatic instrument	Baseline, 12 weeks 24 weeks
Secondary	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