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- Ensaio Clínico NCT07860437
Instructor Interpersonal Behaviours in Classical Pilates as a Pathway to Improve Blood Pressure Control and Well-being in Hypertensive Adults
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Vera A Bártolo, PhD Candidate
- Número de telefone: +351964121601
- E-mail: vera.bartolo@ubi.pt
Locais de estudo
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Tomar, Portugal
- Pavilhão Municipal Patrícia Sampaio - Tomar
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Contato:
- Vera A Bártolo, PhD Candidate
- Número de telefone: +351964121601
- E-mail: vera.bartolo@ubi.pt
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria (for safety reasons):
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: Control: Classical Pilates
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). |
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. |
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Experimental: Experimental: Classical Pilates and Need Supportive Communication
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. |
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Blood Pressure
Prazo: 3 times: Baseline, 12 weeks and 24 weeks
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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. |
3 times: Baseline, 12 weeks and 24 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adherence/Retention
Prazo: 3 times: baseline, 12 weeks and 24 weeks
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Attendance records (percent of sessions attended) and study completion rate. |
3 times: baseline, 12 weeks and 24 weeks
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Motivational Regulation: Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)
Prazo: 3 times: baseline, 12 weeks and 24 weeks
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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"). |
3 times: baseline, 12 weeks and 24 weeks
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Short Form Health Survey-12v2 (SF-12v2)
Prazo: 3 times: baseline, 12 weeks and 24 weeks
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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"). |
3 times: baseline, 12 weeks and 24 weeks
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Satisfaction With Life Scale (SWLS)
Prazo: 3 times: baseline, 12 weeks and 24 weeks
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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"). |
3 times: baseline, 12 weeks and 24 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Diogo M Monteiro, PhD, Universidade de Leiria e do Oeste
- Diretor de estudo: Ana S Alves, PhD, University of Beira Interior
- Investigador principal: Vera A Bártolo, PhD Candidate, University of Beira Interior
Publicações e links úteis
Publicações Gerais
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- Cid L, Monteiro D, Teixeira D, Teques P, Alves S, Moutao J, Silva M, Palmeira A. The Behavioral Regulation in Exercise Questionnaire (BREQ-3) Portuguese-Version: Evidence of Reliability, Validity and Invariance Across Gender. Front Psychol. 2018 Oct 11;9:1940. doi: 10.3389/fpsyg.2018.01940. eCollection 2018.
- Perri 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.
- 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.
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- 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.
- Vallerand, 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
- Sheeran 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.
- Ruider 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.
- Ruider 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.
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- da 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.
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- Woramontri C, Chaunchaiyakul R, Yang AL, Lin YY, Masodsai K. Effect of Mat Pilates Training on Blood Pressure, Inflammatory, and Oxidative Profiles in Hypertensive Elderly. Sports (Basel). 2024 Apr 28;12(5):120. doi: 10.3390/sports12050120.
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Datas de registro do estudo
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Conclusão do estudo (Estimado)
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Enviado pela primeira vez que atendeu aos critérios de CQ
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Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CE-UBI-Pj-2026_027-ID8411
- UID/04045/2025 (Número de outro subsídio/financiamento: FCT - Foundation for Science and Technology)
- UID/PRR/04045/2025 (Número de outro subsídio/financiamento: FCT - Foundation for Science and Technology)
- UID/PRR2/04045/2025 (Número de outro subsídio/financiamento: FCT - Foundation for Science and Technology)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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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