HypertensionNCT04856553
Acute Effects of Handgrip on Blood Pressure in Hypertensive Adults
A study testing Acute effects of handgrip exercise in people with Hypertension, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
Trial summary
The effect of handgrip training on blood pressure reduction has been demonstrated in several studies. However, acutely, there is still divergence regarding the effects of isometric handgrip exercise on blood pressure responses, especially when it is performed at different times of the day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Acute effects of handgrip exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2021to 30 Aug 2021
- 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
- diagnosis of hypertension controlled by up to three antihypertensive medications;
- SBP levels ≤ 180 mmHg and/or DBP ≤110 mmHg;
- no serious heart disease;
- no upper limb musculoskeletal injury that prevents the handgrip.
Who cannot join
- diagnosis of other cardiovascular diseases or diabetes during the study;
- change the class and/or dose of antihypertensive medication during the study;
- worsening of the disease (BP > 180 or use of four or more medications).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Santa Catarina
Florianópolis, Santa Catarina, 88040-900
About this study
Official title: Acute Effects of Handgrip on Vascular Function and Ambulatory Blood Pressure in Hypertensive Adults: A Randomized Controlled Trial
The effect of handgrip training on blood pressure reduction has been demonstrated in several studies. However, acutely, there is still divergence regarding the effects of isometric handgrip exercise on blood pressure responses, especially when it is performed at different times of the day. It is suggested that the magnitude of blood pressure reduction after a single exercise session is able to predict long-term blood pressure behavior. Thus, understanding the effects of isometric handgrip exercise, performed at different times of the day, on blood pressure in adult hypertensive individuals acutely may help to understand the effects of this type of exercise chronically.
- Conditions
- Hypertension
- Being tested
- Acute effects of handgrip exercise
- Keywords
- Exercise, Blood pressure, Strength training, Vascular function
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute effects of handgrip exerciseOther
The participants will be randomized into three sessions, handgrip exercise in the morning, handgrip exercise in the afternoon, and control performed in the morning to analyze the acute effects of handgrip exercise on blood pressure and vascular function at different times of the day. After the morning sessions, ambulatory blood pressure will also be measured for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Handgrip exercise (morning) | Experimental | The handgrip exercise session will be executed with four series (two in each arm) of two minutes of isometric contraction at 30% of maximum voluntary contraction, with a one-minute interval between series in the morning. Receives: Other: Acute effects of handgrip exercise |
| Control | No intervention | In the control session, the participants will remain at rest for the same period of time as in the handgrip exercise protocol. |
| Handgrip exercise (afternoon) | Experimental | The handgrip exercise session will be executed with four series (two in each arm) of two minutes of isometric contraction at 30% of maximum voluntary contraction, with a one-minute interval between series in the afternoon. Receives: Other: Acute effects of handgrip exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ambulatory Blood Pressure
The ambulatory blood pressure will be collected for a 24-hour period using an automatic device (Dyna-MAPA, Cardios, Brazil). The device, duly calibrated, will be connected to a cuff, in the arm of preference, for the evaluation measurements. The device will be programmed to take measurements throughout the day at 15-minute intervals and during the night every 30 minutes (between 11:00 p.m. and 7:00 a.m.). All subjects will be given forms to record possible eventualities during the use of the device.
Measured: 24 hours after the session
Secondary outcomes (2)
Change of clinical blood pressure from pre to post session
For the measurement of clinical blood pressure, the Omron HEM 742 automatic equipment will be used. Initially, the participant will remain for 10 minutes in dorsal decubitus and then a cuff appropriate for the circumference of the participant's arm will be placed. On the right arm, consecutive measurements will be taken, one minute apart, until a difference of less than 4 mmHg between two measurements is reached. For analysis purposes, the average of the last two measurements will be used, as recommended by the 7th Brazilian Guideline on Hypertension.
Measured: Before, immediately after, 15 minutes and 30 minutes after the session.
Change in vascular function from pre to post session
The vascular function will be assessed using the flow-mediated dilation (FMD) technique using the LOGIQ S7 Expert ultrasound device (GE Healthcare), following the recommendations of Thijssen et al. (2019). For FMD collection, the baseline diameter of the artery will be assessed before cuff inflation for a period of at least 30 seconds. The cuff will then be inflated to 50 mmHg above the individual's systolic blood pressure for five minutes, and after this period, the cuff will be deflated and diameter measurement will be assessed for three minutes. The post-deflation diameter measurement will start 30 seconds before the cuff is released. Throughout the collection, continuous measurements of the brachial artery diameter (mm) using the Doppler function will be recorded for future analyses in percentage change.
Measured: Before, immediately after and 30 minutes after the session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Jun 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Mendes Gerage, Universidade Federal de Santa Catarina
- Investigators
- Aline M. Gerage, Dr., Principal investigator, Universidade Federal de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856553
- Sponsor's protocol ID
- ACUTE HANDGRIP 2021
- Status last verified
- Sep 2021
- First submitted
- 14 Apr 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Handgrip on Vascular Function and Ambulatory Blood Pressure in Hypertensive Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04856553
- Acronym / sponsor ID
- ACUTE HANDGRIP 2021
- Conditions
- Hypertension
- Keywords
- Exercise, Blood pressure, Strength training, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 23 Apr 2021 (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 effect of handgrip training on blood pressure reduction has been demonstrated in several studies. However, acutely, there is still divergence regarding the effects of isometric handgrip exercise on blood pressure responses, especially when it is performed at different times of the day. It is suggested that the magnitude of blood pressure reduction after a single exercise session is able to predict long-term blood pressure behavior. Thus, understanding the effects of isometric handgrip exercise, performed at different times of the day, on blood pressure in adult hypertensive individuals acutely may help to understand the effects of this type of exercise chronically.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Handgrip exercise (morning) | Experimental | Other: Acute effects of handgrip exerciseThe handgrip exercise session will be executed with four series (two in each arm) of two minutes of isometric contraction at 30% of maximum voluntary contraction, with a one-minute interval between series in the morning. |
| Control | No intervention | –In the control session, the participants will remain at rest for the same period of time as in the handgrip exercise protocol. |
| Handgrip exercise (afternoon) | Experimental | Other: Acute effects of handgrip exerciseThe handgrip exercise session will be executed with four series (two in each arm) of two minutes of isometric contraction at 30% of maximum voluntary contraction, with a one-minute interval between series in the afternoon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of hypertension controlled by up to three antihypertensive medications;
- SBP levels ≤ 180 mmHg and/or DBP ≤110 mmHg;
- no serious heart disease;
- no upper limb musculoskeletal injury that prevents the handgrip.
Key exclusion criteria (3 listed)
- diagnosis of other cardiovascular diseases or diabetes during the study;
- change the class and/or dose of antihypertensive medication during the study;
- worsening of the disease (BP > 180 or use of four or more medications).
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 |
|---|---|---|
| Acute effects of handgrip exerciseThe participants will be randomized into three sessions, handgrip exercise in the morning, handgrip exercise in the afternoon, and control performed in the morning to analyze the acute effects of handgrip exercise on blood pressure and vascular function at different times of the day. After the morning sessions, ambulatory blood pressure will also be measured for 24 hours. | Other | Handgrip exercise (afternoon), Handgrip exercise (morning) |
Primary outcome
Change in Ambulatory Blood Pressure
Time frame: 24 hours after the session
The ambulatory blood pressure will be collected for a 24-hour period using an automatic device (Dyna-MAPA, Cardios, Brazil). The device, duly calibrated, will be connected to a cuff, in the arm of preference, for the evaluation measurements. The device will be programmed to take measurements throughout the day at 15-minute intervals and during the night every 30 minutes (between 11:00 p.m. and 7:00 a.m.). All subjects will be given forms to record possible eventualities during the use of the device.
2 secondary outcomes
Change of clinical blood pressure from pre to post session
Time frame: Before, immediately after, 15 minutes and 30 minutes after the session.
Change in vascular function from pre to post session
Time frame: Before, immediately after and 30 minutes after the session.
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 30 Sep 2021.
- 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.
Aline M. Gerage, Dr. principal investigator
Universidade Federal de Santa Catarina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute effects of handgrip exercise in people with Hypertension, run by Universidade Federal de Santa Catarina 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 4 inclusion and 3 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 30 Sep 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?
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 Ambulatory Blood Pressure (time frame: 24 hours after the session). 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 30 Sep 2021.