HypertensionPhase 4NCT00611364
Physical Therapy for Hypertensive Elderly
A Phase 4 study testing Physical Therapy and education meetings and education meetings in people with Hypertension, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
Physical therapy for hipertensive elderly: effects in the physical activity and exercise adherence. Introduction: The arterial hypertension (AH) is a clinical syndrome characterized by blood pressure ≥ 140/90mmHg. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Physical Therapy and education meetings and education meetings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2004to Dec 2005
- Phase
- Phase 4
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age or over 60 years,
- both sexes,
- regular frequency of hypertension league;
- practice of physical exercise irregular or absent (reported by professionals objectively on the record)and signature of informed consent. -
Who cannot join
- participate in another research project;
- refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Liga de Hipertensão Arterial da Universidade Federal de Goiás
Goiânia, Goiás, 75000000
About this study
Official title: Physical Therapy for Hipertensive Elderly: Effects in the Physical Activity and Exercise Adherence
Physical therapy for hipertensive elderly: effects in the physical activity and exercise adherence.
Introduction: The arterial hypertension (AH) is a clinical syndrome characterized by blood pressure ≥ 140/90mmHg. Practical of physical activity (PA) and/or physical exercise (PE) is one of the modalities of not farmacological treatment. Hypertensive aged not adhere to this recommendation for presenting factors that make it difficult this practical. Objective: to verify if physical therapy (PT) treatment can improve the AF and EF adhesion of hypertensive aged. Methods: The sample was composed by 43 hypertensive aged of Arterial Hypertensive League of the Federal University of Goiás. Of these, 30 had remained in the study and had been randomized in study group (SG) (16 patients) and control group (CG) (14 patients). SG was submitted of the PT treatment and participated of educative meetings, the CG only participated of the meetings. To evaluate adhesion to the AF was used the pedometer and EF was used a questionnaire of open and closed questions, six minute walk test (6'WT) and ergometric test (ET).
- Conditions
- Hypertension
- Being tested
- Physical Therapy and education meetings, education meetings
- Keywords
- Physical therapy, hypertension, aged, exercise, Physical exercise, Physical activity
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy and education meetingsOther
Physical therapy was realized three two times per week and education meeting every fifteen days
education meetingsOther
This group only participed of education meeting (every fifteen days)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Other: Physical Therapy and education meetings |
| Control group | Active comparator | Not described Receives: Other: education meetings |
What is being measured
The primary outcome is the main question the study is designed to answer.
to verify if physical therapy (PT) treatment can improve the AF and EF adhesion of hypertensive aged
Measured: nine months
Secondary outcomes (1)
To evaluate adhesion to the AF was used the pedometer and EF was used a questionnaire of open and closed questions, six minute walk test (6'WT) and ergometric test (ET)
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startMar 2004
- Primary completionSep 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- Liga de Hipertensão Arterial da Universidade Federal de Goiás
- Investigators
- Priscila Vitorino, MsD, Principal investigator, Liga de Hipertensão Arterial da Universidade Federal de GoiásPaulo César Jardim, PhD, Study chair, Liga de Hipertensão Arterial da Universidade Federal de GoiásFlávia Nogueira, Specialist, Study chair, Liga de Hipertensão Arterial da Universidade Federal de GoiásJuliana Brandão, Specialist, Study chair, Liga de Hipertensão Arterial da Universidade Federal de GoiásHaden Lobo, Specialist, Study chair, Liga de Hipertensão Arterial da Universidade Federal de Goiás
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611364
- Sponsor's protocol ID
- 1-Vitorino
- Other IDs
- 0136/03
- Status last verified
- Jan 2008
- First submitted
- 25 Jan 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy for Hipertensive Elderly: Effects in the Physical Activity and Exercise Adherence
- ClinicalTrials.gov ID
- NCT00611364
- Acronym / sponsor ID
- 1-Vitorino
- Conditions
- Hypertension
- Keywords
- Physical therapy, hypertension, aged, exercise, Physical exercise, Physical activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- Liga de Hipertensão Arterial da Universidade Federal de Goiás
- Study start
- Mar 2004
- Primary completion
- Sep 2004 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 8 Feb 2008 (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.
Physical therapy for hipertensive elderly: effects in the physical activity and exercise adherence.
Introduction: The arterial hypertension (AH) is a clinical syndrome characterized by blood pressure ≥ 140/90mmHg. Practical of physical activity (PA) and/or physical exercise (PE) is one of the modalities of not farmacological treatment. Hypertensive aged not adhere to this recommendation for presenting factors that make it difficult this practical. Objective: to verify if physical therapy (PT) treatment can improve the AF and EF adhesion of hypertensive aged. Methods: The sample was composed by 43 hypertensive aged of Arterial Hypertensive League of the Federal University of Goiás. Of these, 30 had remained in the study and had been randomized in study group (SG) (16 patients) and control group (CG) (14 patients). SG was submitted of the PT treatment and participated of educative meetings, the CG only participated of the meetings. To evaluate adhesion to the AF was used the pedometer and EF was used a questionnaire of open and closed questions, six minute walk test (6'WT) and ergometric test (ET).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Physical Therapy and education meetings |
| Control group | Active comparator | Other: education meetings |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age or over 60 years,
- both sexes,
- regular frequency of hypertension league;
- practice of physical exercise irregular or absent (reported by professionals objectively on the record)and signature of informed consent. -
Key exclusion criteria (2 listed)
- participate in another research project;
- refuse to sign the informed consent.
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 |
|---|---|---|
| Physical Therapy and education meetingsPhysical therapy was realized three two times per week and education meeting every fifteen days | Other | Study group |
| education meetingsThis group only participed of education meeting (every fifteen days) | Other | Control group |
Primary outcome
to verify if physical therapy (PT) treatment can improve the AF and EF adhesion of hypertensive aged
Time frame: nine months
1 secondary outcome
To evaluate adhesion to the AF was used the pedometer and EF was used a questionnaire of open and closed questions, six minute walk test (6'WT) and ergometric test (ET)
Time frame: Nine months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2008.
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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.
Priscila Vitorino, MsD principal investigator
Liga de Hipertensão Arterial da Universidade Federal de Goiás
Paulo César Jardim, PhD study chair
Liga de Hipertensão Arterial da Universidade Federal de Goiás
Flávia Nogueira, Specialist study chair
Liga de Hipertensão Arterial da Universidade Federal de Goiás
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physical Therapy and education meetings and education meetings in people with Hypertension, run by Universidade Federal de Goias 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 20 Oct 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to verify if physical therapy (PT) treatment can improve the AF and EF adhesion of hypertensive aged (time frame: nine 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 Oct 2008.