ClinicalTrials.gg
CompletedNCT03896334ISOPRESSUpdated Jun 10, 2026

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

An interventional study of Supervised Isometric Handgrip Training and Sham comparator - stretching and relaxation exercises in Hypertension, sponsored by Universidade Federal de Santa Catarina. Completed at 5 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Universidade Federal de Santa Catarina · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 139 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Universidade Federal de Santa Catarina is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ( ≥ 26 points)

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
139 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralSupervised 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.

  • BehavioralSham 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.

06

What researchers measure

Primary outcomes

  1. Change in ambulatory systolic blood pressure

    24h-ambulatory blood pressure monitoring

    Time frame: Baseline, 12 weeks 24 weeks

  2. Change in ambulatory diastolic blood pressure

    24h-ambulatory blood pressure monitoring

    Time frame: Baseline, 12 weeks 24 weeks

  3. Change in ambulatory mean blood pressure

    24h-ambulatory blood pressure monitoring

    Time frame: Baseline, 12 weeks 24 weeks

Secondary outcomes

  1. Change in clinic systolic blood pressure

    Clinic blood pressure will be checked using an automatic instrument

    Time frame: Baseline, 12 weeks 24 weeks

  2. Change in clinic diastolic blood pressure

    Clinic blood pressure will be checked using an automatic instrument

    Time frame: Baseline, 12 weeks 24 weeks

  3. Change in clinic mean blood pressure

    Clinic blood pressure will be checked using an automatic instrument

    Time frame: Baseline, 12 weeks 24 weeks

  4. 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.

    Time frame: Baseline, 12 weeks 24 weeks

07

Study locations

5 sites
  • Universidade Federal de Santa Catarina
    Florianópolis, Santa Catarina 88040-900, Brazil
  • Federal University of Sergipe
    Aracaju, Brazil
  • Federal University of Amazonas
    Parintins, Brazil
  • Federal Rural University of Pernambuco
    Recife, Brazil
  • Universidade Nove de Julho
    São Paulo, Brazil
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Jul 2024, 63 months.

Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 63 months is above that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2019
First posted
Mar 29, 2019
StartActual
Apr 5, 2019
Primary completionActual
Jul 15, 2024
CompletionActual
Dec 31, 2025
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03896334
Lead sponsor
Universidade Federal de Santa Catarina
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Aline Mendes Gerage (Principal Investigator, Universidade Federal de Santa Catarina) — Principal investigator
First posted
Mar 29, 2019
Start date
Apr 5, 2019
Primary completion
Jul 15, 2024
Completion
Dec 31, 2025
Last update
Jun 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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