- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03254225
Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability
March 16, 2022 updated by: Alessandra Medeiros, Federal University of São Paulo
This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability of hypertensive elderlies patients.
All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training, an the other will remain sedentary.
Study Overview
Detailed Description
This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability using time and frequency-domains by ECG tracks.
Will be assessed the blood pressure using the ambulatory blood pressure monitoring method of hypertensive elderly patients.
All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training prescribed with a relative workload of 50% of 1 maximal repetition, an the ontrol group will remain sedentary.
Study Type
Interventional
Enrollment (Actual)
40
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
-
-
Sao Paulo
-
Santos, Sao Paulo, Brazil, 11070061
- Fabio Tanil Montrezol
-
-
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
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hypertensives
- Age 60 to 80 years
- Nonactive
Exclusion Criteria:
- Orthopedic problems or other problem that prevented the exercises
- Change in drug treatment during protocol
- Absence in more than 25% of the exercise sessions
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance training
Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).
|
Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).
|
|
No Intervention: Control
in this arm, the group will remain sedentary for the same period of the experimental group, and they will be invited to engage on the raining program after the sedentary period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure change due to resistance training
Time Frame: 16 weeks
|
Blood pressure will be measured by Ambulatorial Monitoring Blood Pressure before and after 16 weeks of intervention.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability - Time domain - change due to resistance training
Time Frame: 16 weeks
|
Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
|
16 weeks
|
|
Heart rate variability - Frequency domain - change due to resistance training
Time Frame: 16 weeks
|
Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
|
16 weeks
|
|
Heart rate variability - Non-linear methods - change due to resistance training
Time Frame: 16 weeks
|
Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fabio T Montrezol, Federal University of São Paulo
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)
April 4, 2018
Primary Completion (Actual)
January 30, 2020
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
August 11, 2017
First Submitted That Met QC Criteria
August 17, 2017
First Posted (Actual)
August 18, 2017
Study Record Updates
Last Update Posted (Actual)
March 17, 2022
Last Update Submitted That Met QC Criteria
March 16, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP1844640
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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