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

5. oktober 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

96

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Vera A Bártolo, PhD Candidate
  • Telefonnummer: +351964121601
  • E-post: vera.bartolo@ubi.pt

Studiesteder

      • Tomar, Portugal
        • Pavilhão Municipal Patrícia Sampaio - Tomar
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.

Eksperimentell: 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.

Andre navn:
  • Interpersonal behaviours

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood Pressure
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence/Retention
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

30. september 2026

Først innsendt som oppfylte QC-kriteriene

30. september 2026

Først lagt ut (Faktiske)

6. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CE-UBI-Pj-2026_027-ID8411
  • UID/04045/2025 (Annet stipend/finansieringsnummer: FCT - Foundation for Science and Technology)
  • UID/PRR/04045/2025 (Annet stipend/finansieringsnummer: FCT - Foundation for Science and Technology)
  • UID/PRR2/04045/2025 (Annet stipend/finansieringsnummer: FCT - Foundation for Science and Technology)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .