StrokeNCT06241339
Chronic Effect of Mat Pilates on Neuromotor, Cardiovascular Functions and Inflammatory Markers in Individuals Post-Stroke Stroke and High Blood Pressure
A study testing Mat Pilates in people with Stroke and High Blood Pressure, run by Rio de Janeiro State University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, High Blood Pressure
- What is being tested?
- Mat Pilates
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Hemiparetic individuals with a history of stroke and/or high blood pressure (prehypertensive and hypertensive patients) who are controlled and do not practice the Pilates method.
Exclusion Criteria: Diagnosis of cardiovascular, respiratory, metabolic or locomotor disease that makes it impossible or contraindicates the practice of the proposed exercises; Uncontrolled hypertension (systolic BP ≥160 mmHg or diastolic pressure and ≥105 mmHg at rest); Spasticity: 3 according to the modified Ashworth Scale; Smoking and frequencies in exercise sessions below 75%.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke, High Blood Pressure
- Being tested
- Mat Pilates
- Keywords
- Autonomy, hemodynamic, balance, muscle strength, chronic reduction in blood pressure
- Medical subject headings
- Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mat PilatesOther
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Postgraduate scholarship
- Responsible party
- Principal investigator, Jeferson Silva da Rocha, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241339
- Sponsor's protocol ID
- 69237423.2.0000.5259
- Status last verified
- Apr 2025
- First submitted
- 26 Jan 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effect of Mat Pilates on Neuromotor, Cardiovascular Functions and Inflammatory Markers in Individuals Post-Stroke Stroke and High Blood Pressure
- ClinicalTrials.gov ID
- NCT06241339
- Acronym / sponsor ID
- 69237423.2.0000.5259
- Conditions
- Stroke, High Blood Pressure
- Keywords
- Autonomy, hemodynamic, balance, muscle strength, chronic reduction in blood pressure
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Postgraduate scholarship
- First posted
- 5 Feb 2024 (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 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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Mat PilatesMat 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. | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mat Pilates in people with Stroke and High Blood Pressure, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 3 Apr 2025. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeferson Rocha, teacher (5521982551927, jefersonsilvarocha@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 3 Apr 2025.