High Blood Pressure (& [Essential Hypertension])NCT07860437
Instructor Interpersonal Behaviours in Classical Pilates as a Pathway to Improve Blood Pressure Control and Well-being in Hypertensive Adults
A study testing Self-Determination Theory Based Supportive Communication in people with High Blood Pressure (& [Essential Hypertension]) and Motivation for Physical Activity, run by Instituto Politécnico de Leiria at 1 site in Portugal.
Trial summary
The aim of this study is to investigate, during a Classical Pilates programme with participants suffering from high blood pressure, whether supportive communication from the instructor to the participant has any effect on the impact of the practice on physiological (blood pressure) and psychological (retention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Pressure (& [Essential Hypertension]), Motivation for Physical Activity, Pilates Method
- What is being tested?
- Self-Determination Theory Based Supportive Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePortugal
- Study dates
- Nov 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (≥18 years) with stage 1 or 2 hypertension (SBP 140-179 mmHg and/or DBP 90-119 mmHg) with confirmed diagnosis;
- stable medication regimen for ≥4 weeks;
- no regular Pilates practice in the last 6 months;
- capacity to provide informed consent.
Who cannot join
- individuals with uncontrolled hypertension (SBP ≥180 or DBP ≥120 mmHg);
- unstable cardiovascular disease;
- significant uncompensated musculoskeletal pathology;
- absolute contraindication to exercise;
- recent change in antihypertensive medication (<4 weeks);
- participation in another interventional study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Pavilhão Municipal Patrícia Sampaio - Tomar
Tomar
Vera A Bártolo, PhD Candidate, +351964121601, vera.bartolo@ubi.pt
About this study
The aim of this study is to investigate, during a Classical Pilates programme with participants suffering from high blood pressure, whether supportive communication from the instructor to the participant has any effect on the impact of the practice on physiological (blood pressure) and psychological (retention, motivation, quality of life and life satisfaction) variables, compared with neutral and routine communication.
Read the detailed description
Background: Pilates appears to have a positive impact on the management and control of blood pressure. However, studies in this field are still inconsistent, combining classical and contemporary techniques as well as equipment, and the protocols are not always clear. Furthermore, there are no studies that highlight the importance of the instructor's communication and the impact this may have on both blood pressure outcomes and psychological outcomes. This protocol aims to explore the influence, on the above-mentioned outcomes, of supportive communication based on Self-Determination Theory, used during classical Pilates classes.
Methods and Design: The study consists of a 24-week, two-arm randomised controlled trial in which adults with hypertension will practise a Classical Pilates sequence in either a control group receiving neutral feedback or an experimental group receiving supportive feedback based on Self-Determination Theory. The 50-minute sessions will take place twice a week. Outcomes will be assessed at three time points: baseline, 12 weeks and 24 weeks, and will consist of measurements of resting blood pressure, adherence, basic psychological needs, motivational regulation, quality of life and life satisfaction.
Discussion: The study will provide an understanding of the influence of supportive communication on physiological and psychological variables, and may contribute to the development of safe, low-cost intervention programmes that ensure adherence and effectiveness in clinical populations.
- Conditions
- High Blood Pressure (& [Essential Hypertension]), Motivation for Physical Activity, Pilates Method, Interpersonal Communication Competence
- Being tested
- Self-Determination Theory Based Supportive Communication, Control
- Keywords
- High Blood Pressure, Interpersonal behaviours, Pilates, Self-Determination Theory, Motivation
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Determination Theory Based Supportive CommunicationBehavioural
Also called Interpersonal behaviours
The intervention will last 24 weeks, and both groups (intervention and control) will follow a classical Pilates matwork programme, twice a week in 50-minute sessions. Lessons for the control and experimental groups will be conducted separately. The programme will consist of 50-minute sessions of classical Pilates matwork sequence, based on the original exercises by Joseph Pilates. In this experimental group, in addition to exercise, supportive communication (autonomy, competence and relatedness) will be introduced.
ControlOther
The control group will undergo the same 24-week intervention as the experimental group, with two 50-minute sessions per week, following the same classical Pilates matwork protocol described above. There is no supportive communication in this variant, instead, communication is neutral, as usual in any class. Neutral communication refers to natural communication that includes tips, technical adjustments, answers to queries and safety advice, but without any specific concerns regarding autonomy, competence or relatedness.
| Study group | Role | What they receive |
|---|---|---|
| Control: Classical Pilates | Other | A group of people with high blood pressure following a predefined Classical Pilates protocol, with neutral communication from the instructors (a regular class that takes into account safety, corrections and adaptations to the exercises, but without any specific support). Receives: Other: Control |
| Experimental: Classical Pilates and Need Supportive Communication | Experimental | A group of people with high blood pressure following a predefined Classical Pilates protocol, with communication designed to support their basic psychological needs, based on Self-Determination Theory. Receives: Behavioral: Self-Determination Theory Based Supportive Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Resting SBP and diastolic blood pressure (DBP) measured with a validated automatic sphygmomanometer following 2024 ESC guidelines (three measurements, 1-2 min interval; the mean of the last two readings will be used for analysis).
Ambulatory blood pressure monitoring will not be included due to logistical and financial constraints in a small-scale study. Furthermore, as this method is uncomfortable, it may itself constitute a barrier to the study, given that three measurements must be taken within a short period of time (3 months). However, automated office blood pressure measurement, taken at rest, when carried out rigorously and in accordance with the guidelines, may offer a level of accuracy similar to that of ambulatory monitoring.
Measured: 3 times: Baseline, 12 weeks and 24 weeks
Secondary outcomes (4)
Adherence/Retention
Attendance records (percent of sessions attended) and study completion rate.
Measured: 3 times: baseline, 12 weeks and 24 weeks
Motivational Regulation: Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)
The Portuguese version of the BREQ-3 assesses the regulation of motivation in exercise through 18 items, which are subdivided into six dimensions (amotivation, external regulation, introjected regulation, identified regulation, integrated regulation and intrinsic motivation), with responses given on a 5-point Likert scale, ranging from 0 ("I strongly disagree") to 4 ("I strongly agree").
Measured: 3 times: baseline, 12 weeks and 24 weeks
Short Form Health Survey-12v2 (SF-12v2)
The SF12v2 is a shortened version of the SF-36 (Short-Form Health Survey-36), which measures physical and mental health in relation to quality of life on a 12-item scale covering eight dimensions (physical functioning, physical role limitations, bodily pain, general health perceptions, energy/vitality, social functioning, emotional role limitations and mental health), which are summarised into two domains: the physical component summary and the mental component summary. Items are scored on a scale of 0 to 100 ("worst health state" to "best health state").
Measured: 3 times: baseline, 12 weeks and 24 weeks
Satisfaction With Life Scale (SWLS)
The SWLS is a subjective, self-reported well-being scale that assesses overall life satisfaction, including five short items rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Measured: 3 times: baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for High Blood Pressure (& [Essential Hypertension])Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Leiria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vera Alexandra da Graça Bártolo, Instituto Politécnico de Leiria
- Investigators
- Diogo M Monteiro, PhD, Study director, Universidade de Leiria e do OesteAna S Alves, PhD, Study director, University of Beira InteriorVera A Bártolo, PhD Candidate, Principal investigator, University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860437
- Sponsor's protocol ID
- CE-UBI-Pj-2026_027-ID8411
- Other IDs
- UID/04045/2025, UID/PRR/04045/2025, UID/PRR2/04045/2025
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the study, including the data dictionary and analyzable dataset, will be available upon reasonable request to the corresponding author, respecting participant anonymity.
Publications
Vansteenkiste, M., Ryan, R. M., Soenens, B. (2020). Basic psychological need theory: Advancements, critical themes, and future directions. Motivation and Emotion, 44(1), 1-31. https://doi.org/10.1007/s11031-019-09818-1
Soepnel LM, Draper CE, Mabetha K, Dennis CL, Prioreschi A, Lye S, Norris SA. A protocol for monitoring fidelity of a preconception-life course intervention in a middle-income setting: the Healthy Life Trajectories Initiative (HeLTI), South Africa. Trials. 2022 Sep 6;23(1):758. doi: 10.1186/s13063-022-06696-w.
PubMed 36068565NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi: 10.1016/S0140-6736(21)01330-1. Epub 2021 Aug 24.
PubMed 34450083McCoy CE. Understanding the Intention-to-treat Principle in Randomized Controlled Trials. West J Emerg Med. 2017 Oct;18(6):1075-1078. doi: 10.5811/westjem.2017.8.35985. Epub 2017 Sep 18.
PubMed 29085540Vallerand, R. J. (1997). Toward a hierarchical model of intrinsic and extrinsic motivation. In M. P. Zanna (Ed.), Advances in experimental social psychology, Vol. 29, pp. 271-360). Academic Press. https://doi.org/10.1016/S0065-2601(08)60019-2
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
PubMed 20332509Sheeran P, Wright CE, Avishai A, Villegas ME, Lindemans JW, Klein WMP, Rothman AJ, Miles E, Ntoumanis N. Self-determination theory interventions for health behavior change: Meta-analysis and meta-analytic structural equation modeling of randomized controlled trials. J Consult Clin Psychol. 2020 Aug;88(8):726-737. doi: 10.1037/ccp0000501. Epub 2020 May 21.
PubMed 32437175Ruider DT, Antunes HKM, Medeiros A. The effect of the pilates method on psychobiological factors and blood pressure in women with hypertension: a randomized controlled trial. Eur J Appl Physiol. 2026 Apr;126(4):1985-1996. doi: 10.1007/s00421-025-06055-y. Epub 2025 Dec 4.
PubMed 41343071Ruider DT, Gomes MFP, Montrezol FT, Antunes HKM, Medeiros A. Pilates training is associated with reduced ambulatory blood pressure and enhanced autonomic reflex responsiveness in women with hypertension. J Hypertens. 2026 Jul 1;44(7):1162-1172. doi: 10.1097/HJH.0000000000004309. Epub 2026 Apr 7.
PubMed 42201655Ryan, R. M., & Deci, E. L. (2017). Self-determination theory: Basic psychological needs in motivation, development, and wellness. Guilford Press
Roerecke M, Kaczorowski J, Myers MG. Comparing Automated Office Blood Pressure Readings With Other Methods of Blood Pressure Measurement for Identifying Patients With Possible Hypertension: A Systematic Review and Meta-analysis. JAMA Intern Med. 2019 Mar 1;179(3):351-362. doi: 10.1001/jamainternmed.2018.6551.
PubMed 30715088Rodrigues F, Hair JF Jr, Neiva HP, Teixeira DS, Cid L, Monteiro D. The Basic Psychological Need Satisfaction and Frustration Scale in Exercise (BPNSFS-E): Validity, Reliability, and Gender Invariance in Portuguese Exercisers. Percept Mot Skills. 2019 Oct;126(5):949-972. doi: 10.1177/0031512519863188. Epub 2019 Jul 25.
PubMed 31345112Pescatello LS, Franklin BA, Fagard R, Farquhar WB, Kelley GA, Ray CA; American College of Sports Medicine. American College of Sports Medicine position stand. Exercise and hypertension. Med Sci Sports Exerc. 2004 Mar;36(3):533-53. doi: 10.1249/01.mss.0000115224.88514.3a.
PubMed 15076798Perri MG, Anton SD, Durning PE, Ketterson TU, Sydeman SJ, Berlant NE, Kanasky WF Jr, Newton RL Jr, Limacher MC, Martin AD. Adherence to exercise prescriptions: effects of prescribing moderate versus higher levels of intensity and frequency. Health Psychol. 2002 Sep;21(5):452-8.
PubMed 12211512Ribeiro-Pereira JA, Bandeira-de-Mello RG, Piccoli V, Calheiros JM. Hypertension prevalence in Portugal: A systematic review and meta-analysis of population-based studies. Rev Port Cardiol. 2026 Mar;45(3):149-162. doi: 10.1016/j.repc.2025.11.008. Epub 2026 Jan 29. English, Portuguese.
PubMed 41617024
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instructor Interpersonal Behaviours in Classical Pilates as a Pathway to Improve Blood Pressure Control and Well-being in Hypertensive Adults
- ClinicalTrials.gov ID
- NCT07860437
- Acronym / sponsor ID
- CE-UBI-Pj-2026_027-ID8411
- Conditions
- High Blood Pressure (& [Essential Hypertension]), Motivation for Physical Activity, Pilates Method, Interpersonal Communication Competence
- Keywords
- High Blood Pressure, Interpersonal behaviours, Pilates, Self-Determination Theory, Motivation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Instituto Politécnico de LeiriaUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Oct 2026 (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 aim of this study is to investigate, during a Classical Pilates programme with participants suffering from high blood pressure, whether supportive communication from the instructor to the participant has any effect on the impact of the practice on physiological (blood pressure) and psychological (retention, motivation, quality of life and life satisfaction) variables, compared with neutral and routine communication.
Detailed description
Background: Pilates appears to have a positive impact on the management and control of blood pressure. However, studies in this field are still inconsistent, combining classical and contemporary techniques as well as equipment, and the protocols are not always clear. Furthermore, there are no studies that highlight the importance of the instructor's communication and the impact this may have on both blood pressure outcomes and psychological outcomes. This protocol aims to explore the influence, on the above-mentioned outcomes, of supportive communication based on Self-Determination Theory, used during classical Pilates classes.
Methods and Design: The study consists of a 24-week, two-arm randomised controlled trial in which adults with hypertension will practise a Classical Pilates sequence in either a control group receiving neutral feedback or an experimental group receiving supportive feedback based on Self-Determination Theory. The 50-minute sessions will take place twice a week. Outcomes will be assessed at three time points: baseline, 12 weeks and 24 weeks, and will consist of measurements of resting blood pressure, adherence, basic psychological needs, motivational regulation, quality of life and life satisfaction.
Discussion: The study will provide an understanding of the influence of supportive communication on physiological and psychological variables, and may contribute to the development of safe, low-cost intervention programmes that ensure adherence and effectiveness in clinical populations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Classical Pilates | Other | Other: ControlA group of people with high blood pressure following a predefined Classical Pilates protocol, with neutral communication from the instructors (a regular class that takes into account safety, corrections and adaptations to the exercises, but without any specific support). |
| Experimental: Classical Pilates and Need Supportive Communication | Experimental | Behavioral: Self-Determination Theory Based Supportive CommunicationA group of people with high blood pressure following a predefined Classical Pilates protocol, with communication designed to support their basic psychological needs, based on Self-Determination Theory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults (≥18 years) with stage 1 or 2 hypertension (SBP 140-179 mmHg and/or DBP 90-119 mmHg) with confirmed diagnosis;
- stable medication regimen for ≥4 weeks;
- no regular Pilates practice in the last 6 months;
- capacity to provide informed consent.
Key exclusion criteria (6 listed)
- individuals with uncontrolled hypertension (SBP ≥180 or DBP ≥120 mmHg);
- unstable cardiovascular disease;
- significant uncompensated musculoskeletal pathology;
- absolute contraindication to exercise;
- recent change in antihypertensive medication (<4 weeks);
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 |
|---|---|---|
| Self-Determination Theory Based Supportive CommunicationAlso: Interpersonal behavioursThe intervention will last 24 weeks, and both groups (intervention and control) will follow a classical Pilates matwork programme, twice a week in 50-minute sessions. Lessons for the control and experimental groups will be conducted separately. The programme will consist of 50-minute sessions of classical Pilates matwork sequence, based on the original exercises by Joseph Pilates. In this experimental group, in addition to exercise, supportive communication (autonomy, competence and relatedness) will be introduced. | Behavioural | Experimental: Classical Pilates and Need Supportive Communication |
| ControlThe control group will undergo the same 24-week intervention as the experimental group, with two 50-minute sessions per week, following the same classical Pilates matwork protocol described above. There is no supportive communication in this variant, instead, communication is neutral, as usual in any class. Neutral communication refers to natural communication that includes tips, technical adjustments, answers to queries and safety advice, but without any specific concerns regarding autonomy, competence or relatedness. | Other | Control: Classical Pilates |
Primary outcome
Blood Pressure
Time frame: 3 times: Baseline, 12 weeks and 24 weeks
Resting SBP and diastolic blood pressure (DBP) measured with a validated automatic sphygmomanometer following 2024 ESC guidelines (three measurements, 1-2 min interval; the mean of the last two readings will be used for analysis). Ambulatory blood pressure monitoring will not be included due to logistical and financial constraints in a small-scale study. Furthermore, as this method is uncomfortable, it may itself constitute a barrier to the study, given that three measurements must be taken within a short period of time (3 months). However, automated office blood pressure measurement, taken at rest, when carried out rigorously and in accordance with the guidelines, may offer a level of accuracy similar to that of ambulatory monitoring.
4 secondary outcomes
Adherence/Retention
Time frame: 3 times: baseline, 12 weeks and 24 weeks
Motivational Regulation: Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)
Time frame: 3 times: baseline, 12 weeks and 24 weeks
Short Form Health Survey-12v2 (SF-12v2)
Time frame: 3 times: baseline, 12 weeks and 24 weeks
Satisfaction With Life Scale (SWLS)
Time frame: 3 times: baseline, 12 weeks and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- BackgroundVansteenkiste, M., Ryan, R. M., Soenens, B. (2020). Basic psychological need theory: Advancements, critical themes, and future directions. Motivation and Emotion, 44(1), 1-31. https://doi.org/10.1007/s11031-019-09818-1
- Background: PubMed 36068565Soepnel LM, Draper CE, Mabetha K, Dennis CL, Prioreschi A, Lye S, Norris SA. A protocol for monitoring fidelity of a preconception-life course intervention in a middle-income setting: the Healthy Life Trajectories Initiative (HeLTI), South Africa. Trials. 2022 Sep 6;23(1):758. doi: 10.1186/s13063-022-06696-w.
- Background: PubMed 34450083NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi: 10.1016/S0140-6736(21)01330-1. Epub 2021 Aug 24.
- Background: PubMed 29085540McCoy CE. Understanding the Intention-to-treat Principle in Randomized Controlled Trials. West J Emerg Med. 2017 Oct;18(6):1075-1078. doi: 10.5811/westjem.2017.8.35985. Epub 2017 Sep 18.
- BackgroundVallerand, R. J. (1997). Toward a hierarchical model of intrinsic and extrinsic motivation. In M. P. Zanna (Ed.), Advances in experimental social psychology, Vol. 29, pp. 271-360). Academic Press. https://doi.org/10.1016/S0065-2601(08)60019-2
- Background: PubMed 20332509Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
- Background: PubMed 32437175Sheeran P, Wright CE, Avishai A, Villegas ME, Lindemans JW, Klein WMP, Rothman AJ, Miles E, Ntoumanis N. Self-determination theory interventions for health behavior change: Meta-analysis and meta-analytic structural equation modeling of randomized controlled trials. J Consult Clin Psychol. 2020 Aug;88(8):726-737. doi: 10.1037/ccp0000501. Epub 2020 May 21.
- Background: PubMed 41343071Ruider DT, Antunes HKM, Medeiros A. The effect of the pilates method on psychobiological factors and blood pressure in women with hypertension: a randomized controlled trial. Eur J Appl Physiol. 2026 Apr;126(4):1985-1996. doi: 10.1007/s00421-025-06055-y. Epub 2025 Dec 4.
- Background: PubMed 42201655Ruider DT, Gomes MFP, Montrezol FT, Antunes HKM, Medeiros A. Pilates training is associated with reduced ambulatory blood pressure and enhanced autonomic reflex responsiveness in women with hypertension. J Hypertens. 2026 Jul 1;44(7):1162-1172. doi: 10.1097/HJH.0000000000004309. Epub 2026 Apr 7.
- BackgroundRyan, R. M., & Deci, E. L. (2017). Self-determination theory: Basic psychological needs in motivation, development, and wellness. Guilford Press
- Background: PubMed 30715088Roerecke M, Kaczorowski J, Myers MG. Comparing Automated Office Blood Pressure Readings With Other Methods of Blood Pressure Measurement for Identifying Patients With Possible Hypertension: A Systematic Review and Meta-analysis. JAMA Intern Med. 2019 Mar 1;179(3):351-362. doi: 10.1001/jamainternmed.2018.6551.
- Background: PubMed 31345112Rodrigues F, Hair JF Jr, Neiva HP, Teixeira DS, Cid L, Monteiro D. The Basic Psychological Need Satisfaction and Frustration Scale in Exercise (BPNSFS-E): Validity, Reliability, and Gender Invariance in Portuguese Exercisers. Percept Mot Skills. 2019 Oct;126(5):949-972. doi: 10.1177/0031512519863188. Epub 2019 Jul 25.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the study, including the data dictionary and analyzable dataset, will be available upon reasonable request to the corresponding author, respecting participant anonymity.
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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.
Diogo M Monteiro, PhD study director
Universidade de Leiria e do Oeste
Ana S Alves, PhD study director
University of Beira Interior
Vera A Bártolo, PhD Candidate principal investigator
University of Beira Interior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Determination Theory Based Supportive Communication in people with High Blood Pressure (& [Essential Hypertension]) and Motivation for Physical Activity, run by Instituto Politécnico de Leiria at 1 site in Portugal.
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 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vera A Bártolo, PhD Candidate (+351964121601, vera.bartolo@ubi.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 3 times: Baseline, 12 weeks and 24 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 NCT07860437, which also lists 30 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 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.