Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Instructor Interpersonal Behaviours in Classical Pilates as a Pathway to Improve Blood Pressure Control and Well-being in Hypertensive Adults

5 de octubre de 2026 actualizado por: Vera Alexandra da Graça Bártolo, Instituto Politécnico de Leiria

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

96

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Vera A Bártolo, PhD Candidate
  • Número de teléfono: +351964121601
  • Correo electrónico: vera.bartolo@ubi.pt

Ubicaciones de estudio

      • Tomar, Portugal
        • Pavilhão Municipal Patrícia Sampaio - Tomar
        • Contacto:
          • Vera A Bártolo, PhD Candidate
          • Número de teléfono: +351964121601
          • Correo electrónico: vera.bartolo@ubi.pt

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 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.

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.

Otros nombres:
  • Interpersonal behaviours

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood Pressure
Periodo de tiempo: 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.

3 times: Baseline, 12 weeks and 24 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence/Retention
Periodo de tiempo: 3 times: baseline, 12 weeks and 24 weeks

Attendance records (percent of sessions attended) and study completion rate.

3 times: baseline, 12 weeks and 24 weeks
Motivational Regulation: Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)
Periodo de tiempo: 3 times: baseline, 12 weeks and 24 weeks

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
Short Form Health Survey-12v2 (SF-12v2)
Periodo de tiempo: 3 times: baseline, 12 weeks and 24 weeks

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
Satisfaction With Life Scale (SWLS)
Periodo de tiempo: 3 times: baseline, 12 weeks and 24 weeks

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Diogo M Monteiro, PhD, Universidade de Leiria e do Oeste
  • Director de estudio: Ana S Alves, PhD, University of Beira Interior
  • Investigador principal: Vera A Bártolo, PhD Candidate, University of Beira Interior

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

30 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Publicado por primera vez (Actual)

6 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CE-UBI-Pj-2026_027-ID8411
  • UID/04045/2025 (Otro número de subvención/financiamiento: FCT - Foundation for Science and Technology)
  • UID/PRR/04045/2025 (Otro número de subvención/financiamiento: FCT - Foundation for Science and Technology)
  • UID/PRR2/04045/2025 (Otro número de subvención/financiamiento: FCT - Foundation for Science and Technology)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .