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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04856553
Other study ID # ACUTE HANDGRIP 2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date August 30, 2021

Study information

Verified date September 2021
Source Universidade Federal de Santa Catarina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. diagnosis of hypertension controlled by up to three antihypertensive medications; 2. SBP levels = 180 mmHg and/or DBP =110 mmHg; 3. no serious heart disease; 4. no upper limb musculoskeletal injury that prevents the handgrip. Exclusion Criteria: 1. diagnosis of other cardiovascular diseases or diabetes during the study; 2. change the class and/or dose of antihypertensive medication during the study; 3. worsening of the disease (BP > 180 or use of four or more medications).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acute effects of handgrip exercise
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.

Locations

Country Name City State
Brazil Universidade Federal de Santa Catarina Florianopolis Santa Catarina

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 hours after the session
Secondary 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. Before, immediately after, 15 minutes and 30 minutes after the session.
Secondary 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. Before, immediately after and 30 minutes after the session.
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