Peripheral Arterial DiseaseIsopress_03NCT03663777
Handgrip Training in Patients With Peripheral Artery Disease
A study testing Isometric handgrip training in people with Peripheral Arterial Disease, run by University of Nove de Julho at 2 sites in Brazil.
Trial summary
The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients which will be randomized into 2 groups (15 per group), IHT and control group (CG). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Isometric handgrip training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Aug 2018to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women in post-menopause phase without hormone replacement therapy
- Ankle-brachial index <0.90
- Not severe obese (≥ 35kg/m2)
- Not present amputation in the limbs
- Have blood pressure levels lower than 160mmHg for systolic and 105mmHg for diastolic
Who cannot join
- patients will only be excluded if they make any medication changes before completing the intervention period or present any health problems that prevent physical activity.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 1 recruiting
- Recruiting
Universidade Nove de Julho
São Paulo, São Paulo, 01525-000
Marilia Correia, PhD, (55 11) 999711669, marilia.correia@live.com
Marilia Correia, PhD
- Completed
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
About this study
Official title: Effects of 12 Weeks of Isometric Handgrip Training in Blood Pressure in Patients With Peripheral Artery Disease
The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will training isometric contraction for 12 weeks. In CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention cardiovascular measures will be obtained.
Read the detailed description
Meta-analyze studies have shown that 4 sets of 2 min of isometric handgrip training (IHT)reduces blood pressure (BP), reaching 10 mmHg for systolic and diastolic 7 mmHg in hypertensive patients after few weeks. However, using this protocol it was not observed any changes in BP in patients with peripheral artery disease. However, it is unknown whether reductions in BP does not occur after isometric handgrip training employing longer and protocol of IHT with more volume. The aim of this study is to analyze the effects of IHT on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients, which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will hold three sessions per week with eight sets of two minutes of isometric contraction at 30% of maximal voluntary contraction and interval of two minutes between them, for 12 weeks. In the CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, BP and cardiac autonomic modulationwill be assessed. Will be used to analyze two-factor variance for repeated measures, with group (IHT and CG) and the time (before and after 12 weeks) as factors and the post-hoc test of Newman-Keuls.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Isometric handgrip training, Control Group
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric handgrip trainingOther
Also called Isometric resistance exercise
Intervention period will last 12 weeks. Experimental group will perform three sessions per week of home-based handgrip exercise. The exercise protocol will consist of eight sets of bilateral handgrip contraction of two minutes of isometric contraction, with 30% of maximum voluntary contraction, and two minutes of interval between sets. Patients will receive a diary to record the sessions and report difficulties during the training. The patients be recommended to increase daily physical activity levels, and weekly, there will be phone contacts with the patients to reinforce the exercise recommendations.
Control GroupOther
Intervention period will last 12 weeks. Patients will be recommended to increase daily physical activity levels, and weekly, there will be phone contacts to reinforce the recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Isometric Handgrip Training | Experimental | Experimental group will perform home-based bilaterall handgrip exercise and will be recommended to increase daily physical activity levels. Receives: Other: Isometric handgrip training |
| Control group | Other | Control gorup will be recommended to increase daily physical activity level Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood pressure at 12 weeks
Blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Change from baseline in cardiac autonomic modulation at 12 weeks
Cardiac autonomic modulation will be measured before and after 12 weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA).
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 posted10 Sep 2018
- Study start1 Aug 2018
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Israelita Albert Einstein
- Responsible party
- Principal investigator, Raphael Mendes Ritti Dias, University of Nove de Julho
- Investigators
- Raphael Dias, PhD, Principal investigator, University of Nove de JulhoMarilia Correia, PhD, Study chair, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663777
- Sponsor's protocol ID
- ISO003
- Acronym
- Isopress_03
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2018
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: WE plan to share the data upon requirement
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12 Weeks of Isometric Handgrip Training in Blood Pressure in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT03663777
- Acronym / sponsor ID
- Isopress_03 / ISO003
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Hospital Israelita Albert Einstein
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Sep 2018 (actual)
- 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 aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will training isometric contraction for 12 weeks. In CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention cardiovascular measures will be obtained.
Detailed description
Meta-analyze studies have shown that 4 sets of 2 min of isometric handgrip training (IHT)reduces blood pressure (BP), reaching 10 mmHg for systolic and diastolic 7 mmHg in hypertensive patients after few weeks. However, using this protocol it was not observed any changes in BP in patients with peripheral artery disease. However, it is unknown whether reductions in BP does not occur after isometric handgrip training employing longer and protocol of IHT with more volume. The aim of this study is to analyze the effects of IHT on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients, which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will hold three sessions per week with eight sets of two minutes of isometric contraction at 30% of maximal voluntary contraction and interval of two minutes between them, for 12 weeks. In the CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, BP and cardiac autonomic modulationwill be assessed. Will be used to analyze two-factor variance for repeated measures, with group (IHT and CG) and the time (before and after 12 weeks) as factors and the post-hoc test of Newman-Keuls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometric Handgrip Training | Experimental | Other: Isometric handgrip trainingExperimental group will perform home-based bilaterall handgrip exercise and will be recommended to increase daily physical activity levels. |
| Control group | Other | Other: Control GroupControl gorup will be recommended to increase daily physical activity level |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women in post-menopause phase without hormone replacement therapy
- Ankle-brachial index <0.90
- Not severe obese (≥ 35kg/m2)
- Not present amputation in the limbs
- Have blood pressure levels lower than 160mmHg for systolic and 105mmHg for diastolic
Key exclusion criteria (1 listed)
- patients will only be excluded if they make any medication changes before completing the intervention period or present any health problems that prevent physical activity.
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: Isometric resistance exerciseIntervention period will last 12 weeks. Experimental group will perform three sessions per week of home-based handgrip exercise. The exercise protocol will consist of eight sets of bilateral handgrip contraction of two minutes of isometric contraction, with 30% of maximum voluntary contraction, and two minutes of interval between sets. Patients will receive a diary to record the sessions and report difficulties during the training. The patients be recommended to increase daily physical activity levels, and weekly, there will be phone contacts with the patients to reinforce the exercise recommendations. | Other | Isometric Handgrip Training |
| Control GroupIntervention period will last 12 weeks. Patients will be recommended to increase daily physical activity levels, and weekly, there will be phone contacts to reinforce the recommendations. | Other | Control group |
Primary outcome
Change from baseline in blood pressure at 12 weeks
Time frame: Baseline and 12 weeks
Blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
1 secondary outcome
Change from baseline in cardiac autonomic modulation at 12 weeks
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. WE plan to share the data upon requirement
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Peripheral Arterial Disease
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.
Raphael Dias, PhD principal investigator
University of Nove de Julho
Marilia Correia, PhD study chair
University of Nove de Julho
2 sites 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 Peripheral Arterial Disease, run by University of Nove de Julho at 2 sites 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 1 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael Dias, PhD (+5519999406878, raphaelritti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in blood pressure at 12 weeks (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 1 May 2026.