- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03982758
Acute Effect of Isometric Exercise on Blood Pressure in Hypertensive Patients
Acute Effect of Isometric Physical Exercise on Blood Pressure in Patients With Controlled Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandre Lehnen, PHD
- Phone Number: +555199768092
- Email: amlehnen@gmail.com
Study Contact Backup
- Name: Patrícia Caetano, graduate
- Phone Number: +5551992039364
- Email: fisio.patriciacaetano@gmail.com
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90040-371
- Recruiting
- Instituto de Cardiologia/ fundação Universitária de Cardiologia
-
Contact:
- Patrícia C de Oliveira
- Phone Number: (51)992039364
- Email: fisio.patriciacaetano@gmail.com
-
Contact:
- Instituto de Cardiologia
- Phone Number: 4124 5132303600
- Email: ppgfuc@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 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.
|
|
Experimental: isometric of lower limbs
Isometric session for lower limbs: 4 series with 2 minutes of contractions sustained at 30% of 1RM.
The rest interval will be 1 minute.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
48 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patricia Caetano, graduate, Instituto de Cardiologia/ fundação Universitária de Cardiologia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCaetano
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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