Hypertensive DiseaseACT-HASNCT02530853
Acupuncture as a Complementary Treatment for Hypertension (ACT-HAS)
A study testing Laser acupuncture in people with Hypertensive Disease, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
This is a randomized clinical trial with blinded, multi-center, involving the Federal University of in Rio de Janeiro(UFRJ), through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of in Espirito Santo, represented by the… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypertensive Disease
- What is being tested?
- Laser acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Jan 2016
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be suffering from essential hypertension;
- Be properly prescribed medication and have difficulty controlling blood pressure keeping regular measurement above was over 140x90 mmHg.
Who cannot join
- A woman in pregnancy;
- Be in possession of any type of cancer;
- being a smoker;
- be alcoholic;
- Be in drug treatment for other diseases including obesity;
- Not dieting for weight loss;
- practice regular physical activity.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Raphael
Rio de Janeiro, Maricá
Raphael Pereira, pesquisacupunt@ufrj.br
About this study
Official title: Acupuncture as Applied Technology to Nursing Care Adult Hypertensive: An Experimental Study.
This is a randomized clinical trial with blinded, multi-center, involving the Federal University of in Rio de Janeiro(UFRJ), through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of in Espirito Santo, represented by the Department of Nursing; and the Higher School of Sciences of the Santa Casa de Misericordia of Vitoria, developed by building doctorate thesis as a final product of the research.
Read the detailed description
The objective of investigation is the effectiveness of acupuncture as a complementary health care to patients with primary hypertension drug therapy.
Methodological approach - Randomized Clinical Trial triple blind.
Population / sample - Patients with Primary Hypertension in drug treatment for over a year and no effective control of blood pressure levels, that is, regular saving measures above was over 140x90 mmHg.
How centers Participants Research, the study covers health units of the Municipal Health of Maricá in Rio de Janeiro, the Municipal of Victoria Health in Espirito Santo, beyond the scope of Integrated Project Research-Service (PIPA), linked to School Nursing Anna Nery /UFRJ.
Primary Objective - To evaluate the effectiveness of acupuncture as a complementary health practice associated with drug treatment used in adults with primary hypertension, based on nursing diagnoses.
Secondary objectives:
- Estimate blood pressure levels after exposure to acupuncture applied in adults with primary hypertension.
- Draw the profile of the most frequent nursing diagnoses in adults with primary hypertension.
- Analyze the effectiveness of acupuncture as a complementary health therapy associated with drug treatment used on these clients, based on nursing diagnoses.
- Conditions
- Hypertensive Disease
- Being tested
- Laser acupuncture
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureOther
Laser acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Laser acupuncture Receives: Other: Laser acupuncture |
| Group B | Sham comparator | Simulation Laser acupuncture Receives: Other: Laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of blood pressure levels.
Measured: six weeks
Secondary outcomes (1)
Improvement of nursing diagnoses
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertensive DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, NEIDE APARECIDA TITONELLI ALVIM, Universidade Federal do Rio de Janeiro
- Investigators
- Neide Alvim, Study director, UFRJClaudia Pereira, Study chair, UFRJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530853
- Sponsor's protocol ID
- 32909414.4.1001.5238
- Other IDs
- 772.508
- Acronym
- ACT-HAS
- Status last verified
- Aug 2015
- First submitted
- 19 Aug 2015
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pereira RDM, Alvim NAT, Pereira CD, Gomes Junior SCDS. Laser acupuncture protocol for essential systemic arterial hypertension: randomized clinical trial. Rev Lat Am Enfermagem. 2018 Jul 16;26:e2936. doi: 10.1590/1518-8345.1887.2936.
PubMed 30020330
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as Applied Technology to Nursing Care Adult Hypertensive: An Experimental Study.
- ClinicalTrials.gov ID
- NCT02530853
- Acronym / sponsor ID
- ACT-HAS / 32909414.4.1001.5238
- Conditions
- Hypertensive Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 21 Aug 2015 (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.
This is a randomized clinical trial with blinded, multi-center, involving the Federal University of in Rio de Janeiro(UFRJ), through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of in Espirito Santo, represented by the Department of Nursing; and the Higher School of Sciences of the Santa Casa de Misericordia of Vitoria, developed by building doctorate thesis as a final product of the research.
Detailed description
The objective of investigation is the effectiveness of acupuncture as a complementary health care to patients with primary hypertension drug therapy.
Methodological approach - Randomized Clinical Trial triple blind.
Population / sample - Patients with Primary Hypertension in drug treatment for over a year and no effective control of blood pressure levels, that is, regular saving measures above was over 140x90 mmHg.
How centers Participants Research, the study covers health units of the Municipal Health of Maricá in Rio de Janeiro, the Municipal of Victoria Health in Espirito Santo, beyond the scope of Integrated Project Research-Service (PIPA), linked to School Nursing Anna Nery /UFRJ.
Primary Objective - To evaluate the effectiveness of acupuncture as a complementary health practice associated with drug treatment used in adults with primary hypertension, based on nursing diagnoses.
Secondary objectives:
- Estimate blood pressure levels after exposure to acupuncture applied in adults with primary hypertension.
- Draw the profile of the most frequent nursing diagnoses in adults with primary hypertension.
- Analyze the effectiveness of acupuncture as a complementary health therapy associated with drug treatment used on these clients, based on nursing diagnoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Laser acupunctureLaser acupuncture |
| Group B | Sham comparator | Other: Laser acupunctureSimulation Laser acupuncture |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be suffering from essential hypertension;
- Be properly prescribed medication and have difficulty controlling blood pressure keeping regular measurement above was over 140x90 mmHg.
Key exclusion criteria (7 listed)
- A woman in pregnancy;
- Be in possession of any type of cancer;
- being a smoker;
- be alcoholic;
- Be in drug treatment for other diseases including obesity;
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 |
|---|---|---|
| Laser acupunctureLaser acupuncture | Other | Group A, Group B |
Primary outcome
Improvement of blood pressure levels.
Time frame: six weeks
1 secondary outcome
Improvement of nursing diagnoses
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Derived from this study: PubMed 30020330Pereira RDM, Alvim NAT, Pereira CD, Gomes Junior SCDS. Laser acupuncture protocol for essential systemic arterial hypertension: randomized clinical trial. Rev Lat Am Enfermagem. 2018 Jul 16;26:e2936. doi: 10.1590/1518-8345.1887.2936.
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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.
Neide Alvim study director
UFRJ
Claudia Pereira study chair
UFRJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture in people with Hypertensive Disease, run by Universidade Federal do Rio de Janeiro 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 2 inclusion and 7 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 25 Aug 2015. 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. Some participants in this study may receive a placebo. 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 Raphael Pereira (5521984531421, rdias_46@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of blood pressure levels. (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530853, which also lists 1 linked publication.
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 25 Aug 2015.