Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896334
Recruitment Status : Suspended (The study is suspended because of the COVID-19 pandemic)
First Posted : March 29, 2019
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Aline Mendes Gerage, Universidade Federal de Santa Catarina

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE April 5, 2019
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Change in ambulatory systolic blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    24h-ambulatory blood pressure monitoring
  • Change in ambulatory diastolic blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    24h-ambulatory blood pressure monitoring
  • Change in ambulatory mean blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    24h-ambulatory blood pressure monitoring
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Change in ambulatory blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
24h-ambulatory blood pressure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Change in clinic systolic blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    Clinic blood pressure will be checked using an automatic instrument
  • Change in clinic diastolic blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    Clinic blood pressure will be checked using an automatic instrument
  • Change in clinic mean blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    Clinic blood pressure will be checked using an automatic instrument
  • Change in heart rate variability [ Time Frame: Baseline, 12 weeks 24 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Change in clinic blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
  • Change in cardiac autonomic modulation [ Time Frame: Baseline, 12 weeks 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Isometric Handgrip Training on Ambulatory Blood Pressure in Patients With Hypertension
Official Title  ICMJE Effect of Isometric Handgrip Training on Ambulatory Blood Pressure: a Multi-center Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Supervised Isometric Handgrip Training
  • Sham Comparator: Control group
    All participants randomized to control group will realize stretching and relaxation exercises, three times per week, during 24 weeks.
    Intervention: Behavioral: Sham comparator - stretching and relaxation exercises
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896334
Other Study ID Numbers  ICMJE ISOPRESS_MULTICENTER STUDY
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Aline Mendes Gerage, Universidade Federal de Santa Catarina
Study Sponsor  ICMJE Universidade Federal de Santa Catarina
Collaborators  ICMJE Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE Not Provided
PRS Account Universidade Federal de Santa Catarina
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP