NCT01863082

Brief Summary

patients with resistant hypertension will be submitted to an exercise protocol in a heated pool for three months

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

May 20, 2013

Last Update Submit

March 19, 2014

Conditions

Hypertension, Resistant to Conventional Therapy

Keywords

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

exercise

EXPERIMENTAL

the patients will be submitted to an exercise protocol

Other: exercise

Interventions

exerciseOTHER

practice of physical exercise

exercise

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • poor adherence to the treatment
  • obesity
  • diabetes
  • smokers
  • secondary causes of hypertension
  • motor disabilities to perform the training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute of São Paulo University Medical School

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lais GB Cruz

    Heart Institute (InCor) HC FMUSP

    STUDY CHAIR

  • Guilherme V Guimarães, PhD

    Heart Institute (InCor) HC FMUSP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lais GB Cruz

CONTACT

+5511988811375laligbcruz@yahoo.com.br

Guilherme V Guimarães, PhD

CONTACT

+551126615419gvguima@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 27, 2013

Study Start

November 1, 2011

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations

BR(1)