NCT06241339

Brief Summary

The Pilates method aims to develop conscious control of body movements. In the literature there are studies that relate the method to postural stabilization, joint rehabilitation, treatment of low back pain, cancer and chronic obstructive pulmonary disease. However, studies on the modality\'s potential for improving isokinetic and antihypertensive strength are scarce, particularly in post-stroke hemiparetic individuals with high blood pressure (BP). The objective of the study is to investigate changes in isokinetic strength and BP, in addition to functional capacity, balance, autonomic modulation, blood biomarkers and endothelial function in hemiparetic individuals due to stroke sequelae and/or with high BP (prehypertensive and hypertensive), after 12 weeks of training with Mat Pilates. Eligible volunteers will be randomly divided into a Mat Pilates group with stroke (GP-AVE), Mat Pilates group with high blood pressure (HA) (GP-HA), control group with stroke (GC-AVE) and control group with HA (GC-HA ). On the first and second visit, measurements of isokinetic strength, functional capacity, static and dynamic balance, heart rate variability, cardiac output, stroke volume, endothelial function, total peripheral vascular resistance and blood biomarkers will be carried out. In addition, 24-hour BP will be measured by ambulatory monitoring (ABPM). GP-AVE and GP-HA will participate in a 12-week Mat Pilates program, totaling 36 training sessions lasting approximately 60 minutes, with an increasing degree of difficulty and complexity throughout the training period. GC-AVE and GC-HA will be instructed to maintain their daily activities during the intervention period, then they will be invited to participate in the Mat Pilates program. The initial measurements will be repeated at the end of the intervention in the Mat Pilates and control groups. Intra and intergroup comparisons will be carried out for all outcomes, for a significance level set at p ≤ 0.05.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

First QC Date

January 26, 2024

Last Update Submit

April 1, 2025

Conditions

Keywords

Autonomyhemodynamicbalancemuscle strengthchronic reduction in blood pressure

Interventions

Mat Pilates training will last 12 weeks, with three weekly trial sessions being held at 48-72h intervals. Each session will last approximately 60 minutes, including: 5 minutes of warm-up (light calisthenic exercises for the shoulder and pelvic girdles); 50 minutes of Mat Pilates exercises; 5 min back to calm. Upon arriving at the training site, volunteers will rest for 10 minutes in a sitting position, after which BP measurements will be taken and HR at rest. Throughout consecutive training sessions, participants will perform Pilates method exercises with a progressively greater degree of difficulty and complexity, following the official recommendations for prescription of resistance exercise for individuals with BP elevated and post-stroke. The exercises will be performed in single sets of 10 repetitions. Groups will be advised to maintain daily activities without physical exercise during the 12-week period.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeferson Silva da Rocha

Rio de Janeiro, 20550-900, Brazil

AVAILABLE

MeSH Terms

Conditions

StrokeHypertension

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Jeferson Rocha, teacher

CONTACT

Paulo Farinatti, scientist

CONTACT

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teacher

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 5, 2024

Last Updated

April 3, 2025

Record last verified: 2025-04

Locations