Effect of Isometric Handgrip Training on Ambulatory Blood Pressure in Patients With Hypertension (ISOPRESS)
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Supervised Isometric Handgrip Training
Sham comparator - stretching and relaxation exercises
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
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).
Sites / Locations
- Universidade Federal de Santa Catarina
- Federal University of SergipeRecruiting
- Federal University of Amazonas
- Federal Rural University of PernambucoRecruiting
- Albert Einstein Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Isometric handgrip training
Control group
Arm Description
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.
All participants randomized to control group will realize stretching and relaxation exercises, three times per week, during 24 weeks.
Outcomes
Primary Outcome Measures
Change in ambulatory systolic blood pressure
24h-ambulatory blood pressure monitoring
Change in ambulatory diastolic blood pressure
24h-ambulatory blood pressure monitoring
Change in ambulatory mean blood pressure
24h-ambulatory blood pressure monitoring
Secondary Outcome Measures
Change in clinic systolic blood pressure
Clinic blood pressure will be checked using an automatic instrument
Change in clinic diastolic blood pressure
Clinic blood pressure will be checked using an automatic instrument
Change in clinic mean blood pressure
Clinic blood pressure will be checked using an automatic instrument
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.
Full Information
NCT ID
NCT03896334
First Posted
March 28, 2019
Last Updated
May 17, 2022
Sponsor
Universidade Federal de Santa Catarina
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT03896334
Brief Title
Effect of Isometric Handgrip Training on Ambulatory Blood Pressure in Patients With Hypertension
Acronym
ISOPRESS
Official Title
Effect of Isometric Handgrip Training on Ambulatory Blood Pressure: a Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Catarina
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 Education and Research Center from Albert Einstein Hospital), 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Isometric handgrip training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
All participants randomized to control group will realize stretching and relaxation exercises, three times per week, during 24 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Supervised Isometric Handgrip Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham comparator - stretching and relaxation exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in ambulatory systolic blood pressure
Description
24h-ambulatory blood pressure monitoring
Time Frame
Baseline, 12 weeks 24 weeks
Title
Change in ambulatory diastolic blood pressure
Description
24h-ambulatory blood pressure monitoring
Time Frame
Baseline, 12 weeks 24 weeks
Title
Change in ambulatory mean blood pressure
Description
24h-ambulatory blood pressure monitoring
Time Frame
Baseline, 12 weeks 24 weeks
Secondary Outcome Measure Information:
Title
Change in clinic systolic blood pressure
Description
Clinic blood pressure will be checked using an automatic instrument
Time Frame
Baseline, 12 weeks 24 weeks
Title
Change in clinic diastolic blood pressure
Description
Clinic blood pressure will be checked using an automatic instrument
Time Frame
Baseline, 12 weeks 24 weeks
Title
Change in clinic mean blood pressure
Description
Clinic blood pressure will be checked using an automatic instrument
Time Frame
Baseline, 12 weeks 24 weeks
Title
Change in heart rate variability
Description
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.
Time Frame
Baseline, 12 weeks 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aline Gerage, PhD
Phone
554837218554
Email
alinegerage@yahoo.com.br
Facility Information:
Facility Name
Universidade Federal de Santa Catarina
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88040-900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALINE M GERAGE, PhD
Phone
4899934799
Email
alinegerage@yahoo.com.br
Facility Name
Federal University of Sergipe
City
Aracaju
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aluísio Lima, PhD
Facility Name
Federal University of Amazonas
City
Parintins
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wagner Domingues, PhD
Facility Name
Federal Rural University of Pernambuco
City
Recife
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Breno Q Farah, PhD
Facility Name
Albert Einstein Hospital
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel G Cucato, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Isometric Handgrip Training on Ambulatory Blood Pressure in Patients With Hypertension
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