Hypertension, Resistant to Conventional TherapyHARNCT01863082
Resistant Hypertension and Physical Activity Performed in a Heated Pool
A study testing exercise in people with Hypertension, Resistant to Conventional Therapy, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
patients with resistant hypertension will be submitted to an exercise protocol in a heated pool for three months Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- poor adherence to the treatment
- obesity
- diabetes
- smokers
- secondary causes of hypertension
- motor disabilities to perform the training
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute of São Paulo University Medical School
São Paulo, São Paulo
Guilherme V Guimarães, PhD, 551126615502, gvguima@usp.br
Lais GB Cruz, +5511988811375, laligbcruz@yahoo.com.br
About this study
Official title: 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
Read the detailed description
pacient´s blood pressure behavior will be compared before and after intervention
- Being tested
- exercise
- Keywords
- Resistant Hypertension
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
practice of physical exercise
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | the patients will be submitted to an exercise protocol Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure value
participants will be followed for the duration of the exercise protocol, an expected average of 12 weeks
Measured: Change from Baseline in Blood Pressure at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startNov 2011
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Edimar Alcides Bocchi, University of Sao Paulo
- Investigators
- Lais GB Cruz, Study chair, Heart Institute (InCor) HC FMUSPGuilherme V Guimarães, PhD, Principal investigator, Heart Institute (InCor) HC FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863082
- Sponsor's protocol ID
- 2010/15649-4
- Acronym
- HAR
- Status last verified
- Mar 2014
- First submitted
- 20 May 2013
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training in a Heated Pool in Patients With Refractory Hypertension
- ClinicalTrials.gov ID
- NCT01863082
- Acronym / sponsor ID
- HAR / 2010/15649-4
- Keywords
- Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: exercisethe patients will be submitted to an exercise protocol |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- poor adherence to the treatment
- obesity
- diabetes
- smokers
- secondary causes of hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisepractice of physical exercise | Other | exercise |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lais GB Cruz study chair
Heart Institute (InCor) HC FMUSP
Guilherme V Guimarães, PhD principal investigator
Heart Institute (InCor) HC FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Hypertension, Resistant to Conventional Therapy, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lais GB Cruz (+5511988811375, laligbcruz@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure value (time frame: Change from Baseline in Blood Pressure at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.