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Resistant Hypertension and Physical Activity Performed in a Heated Pool (HAR)

Primary Purpose

Hypertension, Resistant to Conventional Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
exercise
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension, Resistant to Conventional Therapy focused on measuring Resistant Hypertension

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Heart Institute of São Paulo University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exercise

Arm Description

the patients will be submitted to an exercise protocol

Outcomes

Primary Outcome Measures

blood pressure value
participants will be followed for the duration of the exercise protocol, an expected average of 12 weeks

Secondary Outcome Measures

Full Information

First Posted
May 20, 2013
Last Updated
March 19, 2014
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01863082
Brief Title
Resistant Hypertension and Physical Activity Performed in a Heated Pool
Acronym
HAR
Official Title
Effects of Training in a Heated Pool in Patients With Refractory Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
patients with resistant hypertension will be submitted to an exercise protocol in a heated pool for three months
Detailed Description
pacient´s blood pressure behavior will be compared before and after intervention

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Resistant to Conventional Therapy
Keywords
Resistant Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise
Arm Type
Experimental
Arm Description
the patients will be submitted to an exercise protocol
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
practice of physical exercise
Primary Outcome Measure Information:
Title
blood pressure value
Description
participants will be followed for the duration of the exercise protocol, an expected average of 12 weeks
Time Frame
Change from Baseline in Blood Pressure at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lais GB Cruz
Phone
+5511988811375
Email
laligbcruz@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Guilherme V Guimarães, PhD
Phone
+551126615419
Email
gvguima@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lais GB Cruz
Organizational Affiliation
Heart Institute (InCor) HC FMUSP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guilherme V Guimarães, PhD
Organizational Affiliation
Heart Institute (InCor) HC FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute of São Paulo University Medical School
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilherme V Guimarães, PhD
Phone
551126615502
Email
gvguima@usp.br
First Name & Middle Initial & Last Name & Degree
Lais GB Cruz
Phone
+5511988811375
Email
laligbcruz@yahoo.com.br

12. IPD Sharing Statement

Learn more about this trial

Resistant Hypertension and Physical Activity Performed in a Heated Pool

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