- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04856553
Acute Effects of Handgrip on Blood Pressure in Hypertensive Adults
September 29, 2021 updated by: Aline Mendes Gerage, Universidade Federal de Santa Catarina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santa Catarina
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Florianopolis, Santa Catarina, Brazil, 88040-900
- Universidade Federal de Santa Catarina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Handgrip exercise (morning)
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.
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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.
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No Intervention: Control
In the control session, the participants will remain at rest for the same period of time as in the handgrip exercise protocol.
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Experimental: Handgrip exercise (afternoon)
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Ambulatory Blood Pressure
Time Frame: 24 hours after the session
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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.
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24 hours after the session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of clinical blood pressure from pre to post session
Time Frame: Before, immediately after, 15 minutes and 30 minutes after the session.
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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.
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Before, immediately after, 15 minutes and 30 minutes after the session.
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Change in vascular function from pre to post session
Time Frame: Before, immediately after and 30 minutes after the session.
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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.
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Before, immediately after and 30 minutes after the session.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aline M. Gerage, Dr., Universidade Federal de Santa Catarina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
August 30, 2021
Study Registration Dates
First Submitted
April 14, 2021
First Submitted That Met QC Criteria
April 19, 2021
First Posted (Actual)
April 23, 2021
Study Record Updates
Last Update Posted (Actual)
September 30, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACUTE HANDGRIP 2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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