HypertensionNCT03791307
Effects of Training Based on the Pilates Method on the Blood Pressure of Hypertensive Women
A study testing Traditional Pilates group and Modified Pilates group in people with Hypertension, run by João Luiz Q. Durigan at 1 site in Brazil.
Trial summary
The main objective of this study is to evaluate and compare the effect of the Pilates method associated with aerobic exercise and the traditional Pilates method on the blood pressure of hypertensive medicated women. Read more about this study
- Who is it for?
- Ages 30 to 59 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Traditional Pilates group and Modified Pilates group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Apr 2019to 20 Dec 2019
- 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 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hypertensive women
- Age 30 to 59
- Sedentary or who do not practice any form of physical exercise regularly for at least 6 months
- Make use of antihypertensive medication
- Who have medical clearance for physical exercise
Who cannot join
- Complaint of pain that influences or makes the performance of the tests / exercises proposed impossible
- Congenital or acquired anomalies of upper limbs and lower limbs
- Presence of musculoskeletal disease or injury that interfere the performance of exercises
- Changes in pharmacological treatment during the experimental period
- Release for physical activity suspended during intervention
- Absence in more than 25% of the exercise sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Pressure, Autonomic Heart Rate Modulation, Cardiorespiratory Parameters, Functionality and Quality of Life in Hypertensive Women After 16 Weeks of Training Based on the Pilates Method
The main objective of this study is to evaluate and compare the effect of the Pilates method associated with aerobic exercise and the traditional Pilates method on the blood pressure of hypertensive medicated women. In addition, we aim to analyze and compare the chronic effects of training on cardiac autonomic modulation, on cardiorespiratory fitness, functionality and quality of life.
Read the detailed description
Subjects will be allocated randomly in three groups: (1) Traditional Pilates group, which will perform only exercises based on the traditional Pilates method, (2) Modified Pilates group, which will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, (3) Control group: will not perform any physical exercise during the trial period. The sessions will be performed two times a week, during 16 weeks. Subjects will be evaluated before and after 16 weeks of intervention.
- Conditions
- Hypertension
- Being tested
- Traditional Pilates group, Modified Pilates group
- Keywords
- Pilates method, Blood pressure, Autonomic heart rate modulation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Pilates groupOther
The participants will perform only exercises based on the traditional Pilates method, 2 times a week, for 50 minutes, for 16 weeks.
Modified Pilates groupOther
The participants will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, 2 times a week, for 50 minutes, for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Pilates group | Experimental | This group will perform only exercises based on the traditional Pilates method Receives: Other: Traditional Pilates group |
| Modified Pilates group | Experimental | This group will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer Receives: Other: Modified Pilates group |
| Control group | No intervention | This group will not perform any physical exercise during the trial period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure
Systolic and diastolic blood pressure will be measured by 24-hour Ambulatorial Monitoring Blood Pressure, before and after trial period.
Measured: Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Secondary outcomes (14)
Clinical blood pressure
Clinical assessment of systolic and diastolic blood pressure will be measured by an automatic arm blood pressure monitor after 10 minutes of rest, before and after trial period.
Measured: Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Clinical heart rate
Clinical assessment of heart rate will be measured by a heart rate monitor after 10 minutes of rest, before and after trial period.
Measured: Change from Baseline clinical heart rate at 16 weeks
Autonomic heart rate modulation
Autonomic heart rate modulation will be assessed by the heart rate variability method using a heart rate monitor, before and after trial period.
Measured: Change from Baseline autonomic heart rate modulation at 16 weeks
Ventilatory threshold measured by the cardiopulmonary exercise test
The ventilatory threshold will be measured by the cardiopulmonary exercise test. An ergospirometric exercise test will be performed, consisting of increasing loads, with no pauses between the stages until exhaustion of the volunteer. The examination will be performed in a treadmill with ergospirometric and electrocardiographic analysis.
Measured: Change from baseline and at 16 weeks
Analysis of the quality of life
Quality of life will be analyzed by means of the questionnaire World Health Organization Quality Of Life/Bref (WHOQOL/bref). The questionnaire has twenty-six questions that involve different aspects of daily life and deal with four domains of quality of life: physical, psychological, environmental and social relations. The response is represented by scores ranging from one to five, with the worst score being one and the best score being five. The results of the domains have values between zero and one hundred, with the worst being the closest to zero and the best the closest to one hundred, thus, a value equal to 50 for a given domain can be considered median for that domain.
Measured: Change from Baseline quality of life at 16 weeks
Flexibility
Flexibility will be analyzed by bank of wells test, before and after trial period.
Measured: Change from Baseline flexibility at 16 weeks
Strength
Strength will be analyzed by hydraulic handgrip dynamometer, before and after trial period.
Measured: Change from Baseline strength at 16 weeks
Speed to lift from a sitting position
Speed to lift from a sitting position will be evaluated by a stopwatch, before and after trial period.
Measured: Change from Baseline speed at16 weeks
Speed to lift from a layered position
Speed to lift from a layered position will be evaluated by a stopwatch, before and after trial period
Measured: Change from Baseline speed at 16 weeks
Speed to put on and tie his shoes
Speed to put on and tie his shoes will be evaluated by a stopwatch, before and after trial period.
Measured: Change from Baseline speed at 16 weeks
Body weight
Body weight will be measured using a digital scale, before and after trial period.
Measured: Change from Baseline body weight at 16 weeks
Height
Height will be measured using a stadiometer.
Measured: Change from Baseline at 16 weeks
Body Mass Index
Will be analyzed as weight divided by height squared.
Measured: Change from Baseline body mass index at 16 weeks
Circumference measurements
Will be analyzed the circumference of hip, waist, neck, abdomen, before and after trial period.
Measured: Change from Baseline circumference measurements at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start8 Apr 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- João Luiz Q. Durigan
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of Brasília
- Responsible party
- Sponsor-investigator, João Luiz Q. Durigan, University of Brasilia
- Investigators
- João LQ Durigan, PhD, Study director, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791307
- Sponsor's protocol ID
- CAEE: 99221818.9.0000.0029
- Status last verified
- Mar 2020
- First submitted
- 18 Dec 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martins-Meneses DT, Antunes HK, de Oliveira NR, Medeiros A. Mat Pilates training reduced clinical and ambulatory blood pressure in hypertensive women using antihypertensive medications. Int J Cardiol. 2015 Jan 20;179:262-8. doi: 10.1016/j.ijcard.2014.11.064. Epub 2014 Nov 6.
PubMed 25464462Carpio-Rivera E, Moncada-Jimenez J, Salazar-Rojas W, Solera-Herrera A. Acute Effects of Exercise on Blood Pressure: A Meta-Analytic Investigation. Arq Bras Cardiol. 2016 May;106(5):422-33. doi: 10.5935/abc.20160064. Epub 2016 May 6.
PubMed 27168471Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
PubMed 10881154Gonzales AI, Nery T, Fragnani SG, Pereira F, Lemos RR, Bezerra PP, Haas P. Pilates Exercise for Hypertensive Patients: A Review of the Literature. Altern Ther Health Med. 2016 Sep;22(5):38-43.
PubMed 27622959Malachias MV. 7th Brazilian Guideline of Arterial Hypertension: Presentation. Arq Bras Cardiol. 2016 Sep;107(3 Suppl 3):0. doi: 10.5935/abc.20160140. No abstract available.
PubMed 27819379Niskanen JP, Tarvainen MP, Ranta-Aho PO, Karjalainen PA. Software for advanced HRV analysis. Comput Methods Programs Biomed. 2004 Oct;76(1):73-81. doi: 10.1016/j.cmpb.2004.03.004.
PubMed 15313543Pescatello LS, MacDonald HV, Lamberti L, Johnson BT. Exercise for Hypertension: A Prescription Update Integrating Existing Recommendations with Emerging Research. Curr Hypertens Rep. 2015 Nov;17(11):87. doi: 10.1007/s11906-015-0600-y.
PubMed 26423529Prinsloo GE, Rauch HG, Derman WE. A brief review and clinical application of heart rate variability biofeedback in sports, exercise, and rehabilitation medicine. Phys Sportsmed. 2014 May;42(2):88-99. doi: 10.3810/psm.2014.05.2061.
PubMed 24875976Rtveladze K, Marsh T, Webber L, Kilpi F, Levy D, Conde W, McPherson K, Brown M. Health and economic burden of obesity in Brazil. PLoS One. 2013 Jul 11;8(7):e68785. doi: 10.1371/journal.pone.0068785. Print 2013.
PubMed 23874763Thompson PD, Buchner D, Pina IL, Balady GJ, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF, Gordon NF, Pate RR, Rodriguez BL, Yancey AK, Wenger NK; American Heart Association Council on Clinical Cardiology Subcommittee on Exercise, Rehabilitation, and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism Subcommittee on Physical Activity. Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease: a statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity). Circulation. 2003 Jun 24;107(24):3109-16. doi: 10.1161/01.CIR.0000075572.40158.77. No abstract available.
PubMed 12821592Weber MA, Schiffrin EL, White WB, Mann S, Lindholm LH, Kenerson JG, Flack JM, Carter BL, Materson BJ, Ram CV, Cohen DL, Cadet JC, Jean-Charles RR, Taler S, Kountz D, Townsend RR, Chalmers J, Ramirez AJ, Bakris GL, Wang J, Schutte AE, Bisognano JD, Touyz RM, Sica D, Harrap SB. Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. J Clin Hypertens (Greenwich). 2014 Jan;16(1):14-26. doi: 10.1111/jch.12237. Epub 2013 Dec 17. No abstract available.
PubMed 24341872Xhyheri B, Manfrini O, Mazzolini M, Pizzi C, Bugiardini R. Heart rate variability today. Prog Cardiovasc Dis. 2012 Nov-Dec;55(3):321-31. doi: 10.1016/j.pcad.2012.09.001.
PubMed 23217437da Silva Almeida I, de Souza Andrade L, de Sousa AMM, Junior GC, Turri-Silva N, Cunha Nascimento DD, Mota YL, Durigan JLQ. The Effect of Mat Pilates Training Combined With Aerobic Exercise Versus Mat Pilates Training Alone on Blood Pressure in Women With Hypertension: A Randomized Controlled Trial. Phys Ther. 2022 Feb 1;102(2):pzab258. doi: 10.1093/ptj/pzab258.
PubMed 35084038
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure, Autonomic Heart Rate Modulation, Cardiorespiratory Parameters, Functionality and Quality of Life in Hypertensive Women After 16 Weeks of Training Based on the Pilates Method
- ClinicalTrials.gov ID
- NCT03791307
- Acronym / sponsor ID
- CAEE: 99221818.9.0000.0029
- Conditions
- Hypertension
- Keywords
- Pilates method, Blood pressure, Autonomic heart rate modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- João Luiz Q. DuriganUniversity, hospital or other
- Collaborators
- Catholic University of Brasília
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 2 Jan 2019 (actual)
- 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.
The main objective of this study is to evaluate and compare the effect of the Pilates method associated with aerobic exercise and the traditional Pilates method on the blood pressure of hypertensive medicated women. In addition, we aim to analyze and compare the chronic effects of training on cardiac autonomic modulation, on cardiorespiratory fitness, functionality and quality of life.
Detailed description
Subjects will be allocated randomly in three groups: (1) Traditional Pilates group, which will perform only exercises based on the traditional Pilates method, (2) Modified Pilates group, which will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, (3) Control group: will not perform any physical exercise during the trial period. The sessions will be performed two times a week, during 16 weeks. Subjects will be evaluated before and after 16 weeks of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Pilates group | Experimental | Other: Traditional Pilates groupThis group will perform only exercises based on the traditional Pilates method |
| Modified Pilates group | Experimental | Other: Modified Pilates groupThis group will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer |
| Control group | No intervention | –This group will not perform any physical exercise during the trial period. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Hypertensive women
- Age 30 to 59
- Sedentary or who do not practice any form of physical exercise regularly for at least 6 months
- Make use of antihypertensive medication
- Who have medical clearance for physical exercise
Key exclusion criteria (6 listed)
- Complaint of pain that influences or makes the performance of the tests / exercises proposed impossible
- Congenital or acquired anomalies of upper limbs and lower limbs
- Presence of musculoskeletal disease or injury that interfere the performance of exercises
- Changes in pharmacological treatment during the experimental period
- Release for physical activity suspended during intervention
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 |
|---|---|---|
| Traditional Pilates groupThe participants will perform only exercises based on the traditional Pilates method, 2 times a week, for 50 minutes, for 16 weeks. | Other | Traditional Pilates group |
| Modified Pilates groupThe participants will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, 2 times a week, for 50 minutes, for 16 weeks. | Other | Modified Pilates group |
Primary outcome
Ambulatory blood pressure
Time frame: Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Systolic and diastolic blood pressure will be measured by 24-hour Ambulatorial Monitoring Blood Pressure, before and after trial period.
14 secondary outcomes
Clinical blood pressure
Time frame: Change from Baseline systolic and diastolic Blood Pressure at 16 weeks
Clinical heart rate
Time frame: Change from Baseline clinical heart rate at 16 weeks
Autonomic heart rate modulation
Time frame: Change from Baseline autonomic heart rate modulation at 16 weeks
Ventilatory threshold measured by the cardiopulmonary exercise test
Time frame: Change from baseline and at 16 weeks
Analysis of the quality of life
Time frame: Change from Baseline quality of life at 16 weeks
Flexibility
Time frame: Change from Baseline flexibility at 16 weeks
Strength
Time frame: Change from Baseline strength at 16 weeks
Speed to lift from a sitting position
Time frame: Change from Baseline speed at16 weeks
Speed to lift from a layered position
Time frame: Change from Baseline speed at 16 weeks
Speed to put on and tie his shoes
Time frame: Change from Baseline speed at 16 weeks
Body weight
Time frame: Change from Baseline body weight at 16 weeks
Height
Time frame: Change from Baseline at 16 weeks
Body Mass Index
Time frame: Change from Baseline body mass index at 16 weeks
Circumference measurements
Time frame: Change from Baseline circumference measurements at 16 weeks
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 25 Mar 2020.
- Background: PubMed 25464462Martins-Meneses DT, Antunes HK, de Oliveira NR, Medeiros A. Mat Pilates training reduced clinical and ambulatory blood pressure in hypertensive women using antihypertensive medications. Int J Cardiol. 2015 Jan 20;179:262-8. doi: 10.1016/j.ijcard.2014.11.064. Epub 2014 Nov 6.
- Background: PubMed 27168471Carpio-Rivera E, Moncada-Jimenez J, Salazar-Rojas W, Solera-Herrera A. Acute Effects of Exercise on Blood Pressure: A Meta-Analytic Investigation. Arq Bras Cardiol. 2016 May;106(5):422-33. doi: 10.5935/abc.20160064. Epub 2016 May 6.
- Background: PubMed 10881154Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
- Background: PubMed 27622959Gonzales AI, Nery T, Fragnani SG, Pereira F, Lemos RR, Bezerra PP, Haas P. Pilates Exercise for Hypertensive Patients: A Review of the Literature. Altern Ther Health Med. 2016 Sep;22(5):38-43.
- Background: PubMed 27819379Malachias MV. 7th Brazilian Guideline of Arterial Hypertension: Presentation. Arq Bras Cardiol. 2016 Sep;107(3 Suppl 3):0. doi: 10.5935/abc.20160140. No abstract available.
- Background: PubMed 15313543Niskanen JP, Tarvainen MP, Ranta-Aho PO, Karjalainen PA. Software for advanced HRV analysis. Comput Methods Programs Biomed. 2004 Oct;76(1):73-81. doi: 10.1016/j.cmpb.2004.03.004.
- Background: PubMed 26423529Pescatello LS, MacDonald HV, Lamberti L, Johnson BT. Exercise for Hypertension: A Prescription Update Integrating Existing Recommendations with Emerging Research. Curr Hypertens Rep. 2015 Nov;17(11):87. doi: 10.1007/s11906-015-0600-y.
- Background: PubMed 24875976Prinsloo GE, Rauch HG, Derman WE. A brief review and clinical application of heart rate variability biofeedback in sports, exercise, and rehabilitation medicine. Phys Sportsmed. 2014 May;42(2):88-99. doi: 10.3810/psm.2014.05.2061.
- Background: PubMed 23874763Rtveladze K, Marsh T, Webber L, Kilpi F, Levy D, Conde W, McPherson K, Brown M. Health and economic burden of obesity in Brazil. PLoS One. 2013 Jul 11;8(7):e68785. doi: 10.1371/journal.pone.0068785. Print 2013.
- Background: PubMed 12821592Thompson PD, Buchner D, Pina IL, Balady GJ, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF, Gordon NF, Pate RR, Rodriguez BL, Yancey AK, Wenger NK; American Heart Association Council on Clinical Cardiology Subcommittee on Exercise, Rehabilitation, and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism Subcommittee on Physical Activity. Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease: a statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity). Circulation. 2003 Jun 24;107(24):3109-16. doi: 10.1161/01.CIR.0000075572.40158.77. No abstract available.
- Background: PubMed 24341872Weber MA, Schiffrin EL, White WB, Mann S, Lindholm LH, Kenerson JG, Flack JM, Carter BL, Materson BJ, Ram CV, Cohen DL, Cadet JC, Jean-Charles RR, Taler S, Kountz D, Townsend RR, Chalmers J, Ramirez AJ, Bakris GL, Wang J, Schutte AE, Bisognano JD, Touyz RM, Sica D, Harrap SB. Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. J Clin Hypertens (Greenwich). 2014 Jan;16(1):14-26. doi: 10.1111/jch.12237. Epub 2013 Dec 17. No abstract available.
- Background: PubMed 23217437Xhyheri B, Manfrini O, Mazzolini M, Pizzi C, Bugiardini R. Heart rate variability today. Prog Cardiovasc Dis. 2012 Nov-Dec;55(3):321-31. doi: 10.1016/j.pcad.2012.09.001.
- Individual participant dataSharing planned: Undecided
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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.
João LQ Durigan, PhD study director
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Pilates group and Modified Pilates group in people with Hypertension, run by João Luiz Q. Durigan 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 5 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: finished, as of the sponsor's last update on 25 Mar 2020. 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?
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?
Ambulatory blood pressure (time frame: Change from Baseline systolic and diastolic Blood Pressure at 16 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 NCT03791307, which also lists 13 linked publications.
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 Mar 2020.