Acute Effect of Isometric Exercise on Blood Pressure in Hypertensive Patients
Primary Purpose
Arterial Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
isometric handgrip exercise
isometric of the lower limbs
Sponsored by

About this trial
This is an interventional treatment trial for Arterial Hypertension
Eligibility Criteria
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.
Sites / Locations
- Instituto de Cardiologia/ fundação Universitária de CardiologiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
isometric handgrip exercise
isometric of lower limbs
Arm Description
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 for lower limbs: 4 series with 2 minutes of contractions sustained at 30% of 1RM. The rest interval will be 1 minute.
Outcomes
Primary Outcome Measures
blood pressure
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03982758
First Posted
April 15, 2019
Last Updated
July 27, 2021
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03982758
Brief Title
Acute Effect of Isometric Exercise on Blood Pressure in Hypertensive Patients
Official Title
Acute Effect of Isometric Physical Exercise on Blood Pressure in Patients With Controlled Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
March 18, 2022 (Anticipated)
Study Completion Date
March 18, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
isometric handgrip exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
isometric of lower limbs
Arm Type
Experimental
Arm Description
Isometric session for lower limbs: 4 series with 2 minutes of contractions sustained at 30% of 1RM. The rest interval will be 1 minute.
Intervention Type
Other
Intervention Name(s)
isometric handgrip exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
isometric of the lower limbs
Intervention Description
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.
Primary Outcome Measure Information:
Title
blood pressure
Description
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.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrícia Caetano, graduate
Phone
+5551992039364
Email
fisio.patriciacaetano@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Lehnen, PHD
Phone
+555199768092
Email
amlehnen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Caetano, graduate
Organizational Affiliation
Instituto de Cardiologia/ Fundação Universitária de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Cardiologia/ fundação Universitária de Cardiologia
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90040-371
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrícia C de Oliveira
Phone
(51)992039364
Email
fisio.patriciacaetano@gmail.com
First Name & Middle Initial & Last Name & Degree
Instituto de Cardiologia
Phone
5132303600
Ext
4124
Email
ppgfuc@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Effect of Isometric Exercise on Blood Pressure in Hypertensive Patients
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