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

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ClinicalTrials.gov Identifier: NCT03896334
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Aline Mendes Gerage, Universidade Federal de Santa Catarina

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Supervised Isometric Handgrip Training Behavioral: Sham comparator - stretching and relaxation exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Isometric Handgrip Training on Ambulatory Blood Pressure: a Multi-center Study
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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: Control group
All participants randomized to control group will realize stretching and relaxation exercises, three times per week, during 24 weeks.
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.




Primary Outcome Measures :
  1. Change in ambulatory systolic blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    24h-ambulatory blood pressure monitoring

  2. Change in ambulatory diastolic blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    24h-ambulatory blood pressure monitoring

  3. Change in ambulatory mean blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    24h-ambulatory blood pressure monitoring


Secondary Outcome Measures :
  1. Change in clinic systolic blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    Clinic blood pressure will be checked using an automatic instrument

  2. Change in clinic diastolic blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    Clinic blood pressure will be checked using an automatic instrument

  3. Change in clinic mean blood pressure [ Time Frame: Baseline, 12 weeks 24 weeks ]
    Clinic blood pressure will be checked using an automatic instrument

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896334


Contacts
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Contact: Aline Gerage, PhD 554837218554 alinegerage@yahoo.com.br

Locations
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Brazil
Universidade Federal de Santa Catarina Not yet recruiting
Florianopolis, Santa Catarina, Brazil, 88040-900
Contact: ALINE M GERAGE, PhD    4899934799    alinegerage@yahoo.com.br   
Federal University of Sergipe Recruiting
Aracaju, Brazil
Contact: Aluísio Lima, PhD         
Federal University of Amazonas Not yet recruiting
Parintins, Brazil
Contact: Wagner Domingues, PhD         
Federal Rural University of Pernambuco Recruiting
Recife, Brazil
Contact: Breno Q Farah, PhD         
Albert Einstein Hospital Not yet recruiting
São Paulo, Brazil
Contact: Gabriel G Cucato, PhD         
Sponsors and Collaborators
Universidade Federal de Santa Catarina
Conselho Nacional de Desenvolvimento Científico e Tecnológico

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Responsible Party: Aline Mendes Gerage, Principal Investigator, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier: NCT03896334     History of Changes
Other Study ID Numbers: ISOPRESS_MULTICENTER STUDY
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases