- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01863082
Resistant Hypertension and Physical Activity Performed in a Heated Pool (HAR)
March 19, 2014 updated by: Edimar Alcides Bocchi, University of Sao Paulo
Effects of Training in a Heated Pool in Patients With Refractory Hypertension
patients with resistant hypertension will be submitted to an exercise protocol in a heated pool for three months
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
pacient´s blood pressure behavior will be compared before and after intervention
Study Type
Interventional
Enrollment (Anticipated)
28
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 Contact
- Name: Lais GB Cruz
- Phone Number: +5511988811375
- Email: laligbcruz@yahoo.com.br
Study Contact Backup
- Name: Guilherme V Guimarães, PhD
- Phone Number: +551126615419
- Email: gvguima@usp.br
Study Locations
-
-
-
São Paulo, Brazil
- Recruiting
- Heart Institute of São Paulo University Medical School
-
Contact:
- Lais GB Cruz
- Phone Number: +5511988811375
- Email: laligbcruz@yahoo.com.br
-
Contact:
- Guilherme V Guimarães, PhD
- Phone Number: 551126615502
- Email: gvguima@usp.br
-
-
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
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with uncontrolled blood pressure despite concurrent use of 3 antihypertensive agents, including a diuretic, or the need for more than 3 medications to control blood pressure
Exclusion Criteria:
- poor adherence to the treatment
- obesity
- diabetes
- smokers
- secondary causes of hypertension
- motor disabilities to perform the training
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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exercise
the patients will be submitted to an exercise protocol
|
practice of physical exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood pressure value
Time Frame: Change from Baseline in Blood Pressure at 3 months
|
participants will be followed for the duration of the exercise protocol, an expected average of 12 weeks
|
Change from Baseline in Blood Pressure at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Lais GB Cruz, Heart Institute (InCor) HC FMUSP
- Principal Investigator: Guilherme V Guimaraes, PhD, Heart Institute (InCor) HC FMUSP
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
November 1, 2011
Primary Completion (Anticipated)
August 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
May 20, 2013
First Submitted That Met QC Criteria
May 22, 2013
First Posted (Estimate)
May 27, 2013
Study Record Updates
Last Update Posted (Estimate)
March 20, 2014
Last Update Submitted That Met QC Criteria
March 19, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/15649-4
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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