Arterial HypertensionNCT03982758
Acute Effect of Isometric Exercise on Blood Pressure in Hypertensive Patients
A study testing isometric handgrip exercise and isometric of the lower limbs in people with Arterial Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
International recommendations advocate dynamic or isometric strength training as an adjunct to aerobic exercise. Due to a lack of consensus, this research addresses the acute effects of isometric exercises by handgrip or lower limb isometry as a hypotensive strategy in hypertensive adults. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- isometric handgrip exercise and isometric of the lower limbs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Dec 2019to 18 Mar 2022
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Controlled hypertensive patients (use of medication) sedentary or physically inactive
Who cannot join
- Pregnant women;
- Unstable angina;
- Class II, III or IV heart failure;
- Recent cardiovascular event (last 3 months);
- Chronic renal insufficiency;
- Diabetes;
- History of malignant diseases with life expectancy <2 years;
- Or Orthopedic limitations or any physical or mental limitation that impedes the performance of physical exercises.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Cardiologia/ fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90040-371
Patrícia C de Oliveira, (51)992039364, fisio.patriciacaetano@gmail.com
Instituto de Cardiologia, 5132303600 ext. 4124, ppgfuc@gmail.com
About this study
Official title: Acute Effect of Isometric Physical Exercise on Blood Pressure in Patients With Controlled Hypertension
International recommendations advocate dynamic or isometric strength training as an adjunct to aerobic exercise. Due to a lack of consensus, this research addresses the acute effects of isometric exercises by handgrip or lower limb isometry as a hypotensive strategy in hypertensive adults.
Read the detailed description
This study is characterized as a randomized, controlled and blinded clinical trial for the evaluators and carried out integrally in the Laboratory of Clinical Investigation (LIC) of the Cardiology Institute of Rio Grande do Sul / University Foundation of Cardiology (ICFUC). The project follows all recommendations proposed by the CONSORT Statement.
The study will consist of individuals of both genders, aged between 40 and 70 years who have blood pressure above 120mmhg by 80mhg. The participants, after signing the informed consent, answered a questionnaire that will evaluate the habitual level of physical activity and will be submitted to isometric exercises of palmar grip or quadriceps muscle. Pre- and post-exercise blood pressure will be monitored through the ambulatory blood pressure monitoring (ABPM) method.
- Conditions
- Arterial Hypertension
- Being tested
- isometric handgrip exercise, isometric of the lower limbs
- 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 exerciseOther
Isometric session with handgrip: 4 sets of 2 minutes of contractions sustained at 30% of CVM, for each arm. The time between sets and between arms will be 1 minute rest.
isometric of the lower limbsOther
Isometric session for lower limbs: 4 sets with 2 minutes of contractions sustained at 30% of 1RM. The rest interval will be 1 minute rest.
| Study group | Role | What they receive |
|---|---|---|
| isometric handgrip exercise | Experimental | Isometric session with handgrip: 4 sets of 2 minutes of contractions sustained at 30% of CVM, for each arm. The time between sets and between arms will be 1 minute rest. Receives: Other: isometric handgrip exercise |
| isometric of lower limbs | Experimental | Isometric session for lower limbs: 4 series with 2 minutes of contractions sustained at 30% of 1RM. The rest interval will be 1 minute. Receives: Other: isometric of the lower limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Blood pressure will be evaluated by Ambulatory Blood Pressure Monitoring (ABPM) over 24h. For that, a Dyna-Map® branded instrument will be used, which will measure blood pressure on rest condition and another measure after the exercise session (totaling 48 horas), in all participants of the two study groups.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start9 Dec 2019
- Primary completion18 Mar 2022 (estimated)
- Study completion18 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Caetano, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Patricia Caetano, graduate, Principal investigator, Instituto de Cardiologia/ Fundação Universitária de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982758
- Sponsor's protocol ID
- PCaetano
- Status last verified
- Jul 2021
- First submitted
- 15 Apr 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliveira PC, Dipp T, Waclawovsky G, Lehnen AM. Post-isometric exercise hypotension occurs irrespective of muscle mass in adults with hypertension: A randomized clinical trial. Clinics (Sao Paulo). 2025 Apr 16;80:100612. doi: 10.1016/j.clinsp.2025.100612. eCollection 2025.
PubMed 40245790
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Isometric Physical Exercise on Blood Pressure in Patients With Controlled Hypertension
- ClinicalTrials.gov ID
- NCT03982758
- Acronym / sponsor ID
- PCaetano
- Conditions
- Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 18 Mar 2022 (estimated)
- Study completion
- 18 Mar 2022 (estimated)
- First posted
- 12 Jun 2019 (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.
International recommendations advocate dynamic or isometric strength training as an adjunct to aerobic exercise. Due to a lack of consensus, this research addresses the acute effects of isometric exercises by handgrip or lower limb isometry as a hypotensive strategy in hypertensive adults.
Detailed description
This study is characterized as a randomized, controlled and blinded clinical trial for the evaluators and carried out integrally in the Laboratory of Clinical Investigation (LIC) of the Cardiology Institute of Rio Grande do Sul / University Foundation of Cardiology (ICFUC). The project follows all recommendations proposed by the CONSORT Statement.
The study will consist of individuals of both genders, aged between 40 and 70 years who have blood pressure above 120mmhg by 80mhg. The participants, after signing the informed consent, answered a questionnaire that will evaluate the habitual level of physical activity and will be submitted to isometric exercises of palmar grip or quadriceps muscle. Pre- and post-exercise blood pressure will be monitored through the ambulatory blood pressure monitoring (ABPM) method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isometric handgrip exercise | Experimental | Other: isometric handgrip exerciseIsometric session with handgrip: 4 sets of 2 minutes of contractions sustained at 30% of CVM, for each arm. The time between sets and between arms will be 1 minute rest. |
| isometric of lower limbs | Experimental | Other: isometric of the lower limbsIsometric session for lower limbs: 4 series with 2 minutes of contractions sustained at 30% of 1RM. The rest interval will be 1 minute. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Controlled hypertensive patients (use of medication) sedentary or physically inactive
Key exclusion criteria (8 listed)
- Pregnant women;
- Unstable angina;
- Class II, III or IV heart failure;
- Recent cardiovascular event (last 3 months);
- Chronic renal insufficiency;
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 exerciseIsometric session with handgrip: 4 sets of 2 minutes of contractions sustained at 30% of CVM, for each arm. The time between sets and between arms will be 1 minute rest. | Other | isometric handgrip exercise |
| isometric of the lower limbsIsometric session for lower limbs: 4 sets with 2 minutes of contractions sustained at 30% of 1RM. The rest interval will be 1 minute rest. | Other | isometric of lower limbs |
Primary outcome
blood pressure
Time frame: 48 hours
Blood pressure will be evaluated by Ambulatory Blood Pressure Monitoring (ABPM) over 24h. For that, a Dyna-Map® branded instrument will be used, which will measure blood pressure on rest condition and another measure after the exercise session (totaling 48 horas), in all participants of the two study groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 40245790Oliveira PC, Dipp T, Waclawovsky G, Lehnen AM. Post-isometric exercise hypotension occurs irrespective of muscle mass in adults with hypertension: A randomized clinical trial. Clinics (Sao Paulo). 2025 Apr 16;80:100612. doi: 10.1016/j.clinsp.2025.100612. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Patricia Caetano, graduate principal investigator
Instituto de Cardiologia/ Fundação Universitária de Cardiologia
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 exercise and isometric of the lower limbs in people with Arterial Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrícia Caetano, graduate (+5551992039364, fisio.patriciacaetano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982758, which also lists 1 linked publication.
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 28 Jul 2021.