Effects of Pilates Method and Aerobic Training in Hypertensive Subjects

April 29, 2020 updated by: Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria

Effects of Pilates Method and Aerobic Training in Hypertensive Subjects: a Randomized Trial

This study evaluates the effects of Pilates method and aerobic training in hypertensive subjects. Half of participants will be trained with Pilates, while the other half will be trained with aerobic exercise during 8 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Santa Maria, RS, Brazil, 97.105-900
        • University Federal of Santa Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects with high blood pressure controled by medication;
  • sedentary.

Exclusion Criteria:

  • IMC≥30 kg/m²
  • using beta blockers
  • smokers or that interrupted the routine less than 6 months
  • musculoskeletal diseases in evolution or with current symptomatic
  • rheumatological diseases
  • other cardiovascular disease
  • renal disease due to hypertension
  • endocrine, neurological, oncological, immunological, hematological and psychiatric diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Pilates method group
The participants will do Mat Pilates.
Other: Pilates
1 hour of Mat Pilates, 2 times a week, during 8 weeks.
Other Names:
  • Pilates method
  • Mat Pilates
ACTIVE_COMPARATOR: Aerobic training group
The participants will do aerobic exercise on treadmill.
Other: Aerobic Exercise
1 hour of aerobic training on a treadmill, 3 times a week, during 8 weeks.
Other Names:
  • aerobic training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline casual systolic blood pressure at 8 weeks
Time Frame: baseline and 8 weeks
It will be evaluated with oscillometric method of measuring blood pressure with an automated cuff.
baseline and 8 weeks
Change from baseline 24-hour systolic blood pressure at 8 weeks
Time Frame: baseline and 8 weeks
It will be evaluated by 24-hour ambulatory BP monitoring (ABPM)
baseline and 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Casual diastolic blood pressure
Time Frame: baseline and 8 weeks
It will be evaluated with oscillometric method of measuring blood pressure with an automated cuff.
baseline and 8 weeks
Heart rate variability
Time Frame: baseline and 8 weeks
It will be evaluated using a previously validated heart rate monitor Polar 810i, and the results will be analyzed in time- and frequency-domains.
baseline and 8 weeks
Diastolic and mean blood pressure
Time Frame: baseline and 8 weeks
It will be evaluated by 24-hour ambulatory BP monitoring (ABPM)
baseline and 8 weeks
Functional capacity
Time Frame: baseline and 8 weeks
Evaluate by Six-Minute Walk Test (6MWT)
baseline and 8 weeks
Respiratory muscle strength
Time Frame: baseline and 8 weeks
The maximal inspiratory and expiratory pressures will be evaluated with manovacuometer
baseline and 8 weeks
Muscle strength
Time Frame: baseline and 8 weeks
The muscles (quadriceps, gastrocnemius, abdominal and spine extensors) will be evaluated with dynamometer.
baseline and 8 weeks
Flexibility
Time Frame: baseline and 8 weeks
It will be evaluated by bank of Wells test.
baseline and 8 weeks
Body Mass Index
Time Frame: baseline and 8 weeks
It will be calculated as weight (kg) divided by height squared.
baseline and 8 weeks
Oxidative damage
Time Frame: baseline and 8 weeks
It will be evaluated by advanced oxidation protein products (AOPP)
baseline and 8 weeks
Antioxidant capacity
Time Frame: baseline and 8 weeks
It will be evaluated by total antioxidant capacity (TAC).
baseline and 8 weeks
Lipid profile
Time Frame: baseline and 8 weeks
By blood analysis (LDL, HDL, total cholesterol, glucose and triglycerides).
baseline and 8 weeks
Endothelial function
Time Frame: baseline and 8 weeks
By blood analysis (Nitrite measurement/NOx).
baseline and 8 weeks
Inflammation
Time Frame: baseline and 8 weeks
It will be evaluated by C-reactive protein in blood analysis
baseline and 8 weeks
Creatinine
Time Frame: baseline and 8 weeks
By blood analysis
baseline and 8 weeks
Lactate
Time Frame: baselina and 8 weeks
By blood analysis
baselina and 8 weeks
Creatine kinase
Time Frame: baseline and 8 weeks
By blood analysis
baseline and 8 weeks
Questionnaire of Quality of life
Time Frame: baseline and 8 weeks
It will be evaluated by Mini-questionnaire of Quality of Life in Hypertension (MINICHAL)
baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Santa Maria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPMAT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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