HypertensionNCT02348138
Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives
A study testing Isometric handgrip training in people with Hypertension, run by University of Pernambuco at 1 site in Brazil.
Trial summary
The main purpose this study is to analyze the effects of isometric handgrip training on cardiovascular risk in hypertensive. For this, approximately 60 hypertensive, under anti-hypertensive medication, will be selected and randomly distributed into three groups: home-based isometric handgrip training (HBT), supervised… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Isometric handgrip training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hypertension;
- Must be under anti-hypertensive medications of three months or more;
- May not present diabetes or other cardiovascular diseases;
- May not engaged in regular physical activity;
- May not have disabilities that compromise the physical activity practices.
Who cannot join
- Not perform more than 85% of the training sessions;
- Present diagnosis of metabolic diseases, cardiovascular or pulmonary during the study;
- Adherence to other physical activity program beyond the training offered by this study;
- Change in class and / or dose of medication during the study;
- Not using the medication regularly;
- Worsening of the disease.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose this study is to analyze the effects of isometric handgrip training on cardiovascular risk in hypertensive. For this, approximately 60 hypertensive, under anti-hypertensive medication, will be selected and randomly distributed into three groups: home-based isometric handgrip training (HBT), supervised isometric handgrip training (ST) and control group (CG).Subjects assigned to the HBT and ST will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction. However, the subjects of the HBT group conduct the training without daily supervision. Subjects randomized to the CG will be encouraged to increase the level of physical activity and make healthy eating, without, however, receive specific recommendations.Baseline and after 12 weeks of intervention, the following cardiovascular risk indicators will be obtained: blood pressure, arterial stiffness, cardiac autonomic modulation, vasodilatory capacity and oxidative and inflammatory stress markers, in addition to microalbuminuria. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be applied for within and between groups comparison. If the premises of this test are met. The level of significance that will be adopted is p<0.05.
- Conditions
- Hypertension
- Being tested
- Isometric handgrip training
- Keywords
- Isometric Handgrip
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric handgrip trainingOther
Also called Exercise
The two experimental groups (HBT and ST) will receive intervention with isometric handgrip exercise for 12 weeks, and the HBT group without daily supervision.
| Study group | Role | What they receive |
|---|---|---|
| Home-based isometric handgrip training | Experimental | All participants that will be assigned to home-based isometric handgrip training (HBT) will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction; however, the training will be performed without daily supervision. Therefore, the subjects will receive a logbook to record the exercise sessions. In addition, visits will be scheduled at weeks 1, 3, 6, 9 and 11 to provide feedback to individuals and discuss potential problems in conducting training. Receives: Other: Isometric handgrip training |
| Supervised isometric handgrip training | Experimental | All participants that will be assigned to supervised isometric handgrip training (ST) will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction with. The training will be performed with daily supervision. Receives: Other: Isometric handgrip training |
| Control group | No intervention | Subjects randomized to the control group (CG) will be encouraged to increase the level of physical activity and make healthy eating, without, however, receive specific recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office blood pressure
Measured: Baseline and 12 weeks
Secondary outcomes (7)
Change in ambulatory blood pressure
Measured: Basaline and 12 weeks
Change in central blood pressure
Measured: Basaline and 12 weeks
Change in cardiac autonomic modulation
Measured: Baseline and 12 weeks
Change in vasodilatory capacity
Measured: Baseline and 12 weeks
Change in arterial stiffness
Measured: Baseline and 12 weeks
Change in markers of oxidative stress
Measured: Baseline and 12 weeks
Change in markers of inflammation
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Ciência e Tecnologia de Pernambuco
- Responsible party
- Principal investigator, Breno Quintella Farah, University of Pernambuco
- Investigators
- Raphael M Ritti-Dias, Doctor, Study director, University of PernambucoBreno Q Farah, Phd student, Principal investigator, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348138
- Sponsor's protocol ID
- ISOPRESS
- Status last verified
- Oct 2017
- First submitted
- 22 Jan 2015
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isometric Handgrip Training on Cardiovascular Risk in Hypertensives
- ClinicalTrials.gov ID
- NCT02348138
- Acronym / sponsor ID
- ISOPRESS
- Conditions
- Hypertension
- Keywords
- Isometric Handgrip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Ciência e Tecnologia de Pernambuco
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose this study is to analyze the effects of isometric handgrip training on cardiovascular risk in hypertensive. For this, approximately 60 hypertensive, under anti-hypertensive medication, will be selected and randomly distributed into three groups: home-based isometric handgrip training (HBT), supervised isometric handgrip training (ST) and control group (CG).Subjects assigned to the HBT and ST will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction. However, the subjects of the HBT group conduct the training without daily supervision. Subjects randomized to the CG will be encouraged to increase the level of physical activity and make healthy eating, without, however, receive specific recommendations.Baseline and after 12 weeks of intervention, the following cardiovascular risk indicators will be obtained: blood pressure, arterial stiffness, cardiac autonomic modulation, vasodilatory capacity and oxidative and inflammatory stress markers, in addition to microalbuminuria. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be applied for within and between groups comparison. If the premises of this test are met. The level of significance that will be adopted is p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home-based isometric handgrip training | Experimental | Other: Isometric handgrip trainingAll participants that will be assigned to home-based isometric handgrip training (HBT) will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction; however, the training will be performed without daily supervision. Therefore, the subjects will receive a logbook to record the exercise sessions. In addition, visits will be scheduled at weeks 1, 3, 6, 9 and 11 to provide feedback to individuals and discuss potential problems in conducting training. |
| Supervised isometric handgrip training | Experimental | Other: Isometric handgrip trainingAll participants that will be assigned to supervised isometric handgrip training (ST) will train three times per week for a total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction with. The training will be performed with daily supervision. |
| Control group | No intervention | –Subjects randomized to the control group (CG) will be encouraged to increase the level of physical activity and make healthy eating, without, however, receive specific recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of hypertension;
- Must be under anti-hypertensive medications of three months or more;
- May not present diabetes or other cardiovascular diseases;
- May not engaged in regular physical activity;
- May not have disabilities that compromise the physical activity practices.
Key exclusion criteria (6 listed)
- Not perform more than 85% of the training sessions;
- Present diagnosis of metabolic diseases, cardiovascular or pulmonary during the study;
- Adherence to other physical activity program beyond the training offered by this study;
- Change in class and / or dose of medication during the study;
- Not using the medication regularly;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric handgrip trainingAlso: ExerciseThe two experimental groups (HBT and ST) will receive intervention with isometric handgrip exercise for 12 weeks, and the HBT group without daily supervision. | Other | Home-based isometric handgrip training, Supervised isometric handgrip training |
Primary outcome
Change in office blood pressure
Time frame: Baseline and 12 weeks
7 secondary outcomes
Change in ambulatory blood pressure
Time frame: Basaline and 12 weeks
Change in central blood pressure
Time frame: Basaline and 12 weeks
Change in cardiac autonomic modulation
Time frame: Baseline and 12 weeks
Change in vasodilatory capacity
Time frame: Baseline and 12 weeks
Change in arterial stiffness
Time frame: Baseline and 12 weeks
Change in markers of oxidative stress
Time frame: Baseline and 12 weeks
Change in markers of inflammation
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael M Ritti-Dias, Doctor study director
University of Pernambuco
Breno Q Farah, Phd student principal investigator
University of Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric handgrip training in people with Hypertension, run by University of Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in office blood pressure (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.