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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03982758
Other study ID # PCaetano
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 9, 2019
Est. completion date March 18, 2022

Study information

Verified date July 2021
Source Instituto de Cardiologia do Rio Grande do Sul
Contact Patrícia Caetano, graduate
Phone +5551992039364
Email fisio.patriciacaetano@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 18, 2022
Est. primary completion date March 18, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Controlled hypertensive patients (use of medication) sedentary or physically inactive Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
isometric handgrip exercise
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 limbs
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.

Locations

Country Name City State
Brazil Instituto de Cardiologia/ fundação Universitária de Cardiologia Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary blood pressure Blood pressure will be evaluated by Ambulatory Blood Pressure Monitoring (ABPM) over 24h. For that, a Dyna-MapĀ® 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. 48 hours
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