Resistant Hypertension and Physical Activity Performed in... | NCT01863082

Studies
Resistant Hypertension and Physical Activity Performed in a Heated Pool

NCT01863082

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Mar 20, 2014Estimated

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Hypertension, Resistant to Conventional Therapy

Interventions

exercise

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Aug 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

May 20, 2013

First Submission Date that Met QC Criteria

May 22, 2013

First Posted Date

May 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2014

Last Update Posted Date

Mar 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Edimar Alcides Bocchi, PHD, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exercise	Experimental	the patients will be submitted to an exercise protocol	Other: exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise	Other	practice of physical exercise	exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood pressure value	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lais GB Cruz	Contact	+5511988811375		laligbcruz@yahoo.com.br
Guilherme V Guimarães, PhD	Contact	+551126615419		gvguima@usp.br

Overall Officials

Name	Affiliation	Role
Lais GB Cruz	Heart Institute (InCor) HC FMUSP	Study Chair
Guilherme V Guimarães, PhD	Heart Institute (InCor) HC FMUSP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart Institute of São Paulo University Medical School	Recruiting	São Paulo	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
C563514	Hypertension Resistant to Conventional Therapy

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided