HypertensionNCT03214016
Effects of Pilates Method and Aerobic Training in Hypertensive Subjects
A study testing Aerobic Exercise and Pilates in people with Hypertension, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Aerobic Exercise and Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2017to 31 Aug 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with high blood pressure controled by medication;
- sedentary.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University Federal of Santa Maria
Santa Maria, Rio Grande do Sul, 97.105-900
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Aerobic Exercise, Pilates
- Keywords
- Pilates Training, Aerobic Exercises, Hypertension, Clinical trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Also called aerobic training
1 hour of aerobic training on a treadmill, 3 times a week, during 8 weeks.
PilatesOther
Also called Pilates method, Mat Pilates
1 hour of Mat Pilates, 2 times a week, during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pilates method group | Experimental | The participants will do Mat Pilates. Receives: Other: Pilates |
| Aerobic training group | Active comparator | The participants will do aerobic exercise on treadmill. Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline casual systolic blood pressure at 8 weeks
It will be evaluated with oscillometric method of measuring blood pressure with an automated cuff.
Measured: baseline and 8 weeks
Change from baseline 24-hour systolic blood pressure at 8 weeks
It will be evaluated by 24-hour ambulatory BP monitoring (ABPM)
Measured: baseline and 8 weeks
Secondary outcomes (17)
Casual diastolic blood pressure
It will be evaluated with oscillometric method of measuring blood pressure with an automated cuff.
Measured: baseline and 8 weeks
Heart rate variability
It will be evaluated using a previously validated heart rate monitor Polar 810i, and the results will be analyzed in time- and frequency-domains.
Measured: baseline and 8 weeks
Diastolic and mean blood pressure
It will be evaluated by 24-hour ambulatory BP monitoring (ABPM)
Measured: baseline and 8 weeks
Functional capacity
Evaluate by Six-Minute Walk Test (6MWT)
Measured: baseline and 8 weeks
Respiratory muscle strength
The maximal inspiratory and expiratory pressures will be evaluated with manovacuometer
Measured: baseline and 8 weeks
Muscle strength
The muscles (quadriceps, gastrocnemius, abdominal and spine extensors) will be evaluated with dynamometer.
Measured: baseline and 8 weeks
Flexibility
It will be evaluated by bank of Wells test.
Measured: baseline and 8 weeks
Body Mass Index
It will be calculated as weight (kg) divided by height squared.
Measured: baseline and 8 weeks
Oxidative damage
It will be evaluated by advanced oxidation protein products (AOPP)
Measured: baseline and 8 weeks
Antioxidant capacity
It will be evaluated by total antioxidant capacity (TAC).
Measured: baseline and 8 weeks
Lipid profile
By blood analysis (LDL, HDL, total cholesterol, glucose and triglycerides).
Measured: baseline and 8 weeks
Endothelial function
By blood analysis (Nitrite measurement/NOx).
Measured: baseline and 8 weeks
Inflammation
It will be evaluated by C-reactive protein in blood analysis
Measured: baseline and 8 weeks
Creatinine
By blood analysis
Measured: baseline and 8 weeks
Lactate
By blood analysis
Measured: baselina and 8 weeks
Creatine kinase
By blood analysis
Measured: baseline and 8 weeks
Questionnaire of Quality of life
It will be evaluated by Mini-questionnaire of Quality of Life in Hypertension (MINICHAL)
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start20 Aug 2017
- Primary completion30 May 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214016
- Sponsor's protocol ID
- EPMAT
- Status last verified
- Apr 2020
- First submitted
- 3 Jul 2017
- Last updated
- 1 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Method and Aerobic Training in Hypertensive Subjects: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03214016
- Acronym / sponsor ID
- EPMAT
- Conditions
- Hypertension
- Keywords
- Pilates Training, Aerobic Exercises, Hypertension, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 11 Jul 2017 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates method group | Experimental | Other: PilatesThe participants will do Mat Pilates. |
| Aerobic training group | Active comparator | Other: Aerobic ExerciseThe participants will do aerobic exercise on treadmill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects with high blood pressure controled by medication;
- sedentary.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Aerobic ExerciseAlso: aerobic training1 hour of aerobic training on a treadmill, 3 times a week, during 8 weeks. | Other | Aerobic training group |
| PilatesAlso: Pilates method, Mat Pilates1 hour of Mat Pilates, 2 times a week, during 8 weeks. | Other | Pilates method group |
Primary outcome
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.
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)
17 secondary outcomes
Casual diastolic blood pressure
Time frame: baseline and 8 weeks
Heart rate variability
Time frame: baseline and 8 weeks
Diastolic and mean blood pressure
Time frame: baseline and 8 weeks
Functional capacity
Time frame: baseline and 8 weeks
Respiratory muscle strength
Time frame: baseline and 8 weeks
Muscle strength
Time frame: baseline and 8 weeks
Flexibility
Time frame: baseline and 8 weeks
Body Mass Index
Time frame: baseline and 8 weeks
Oxidative damage
Time frame: baseline and 8 weeks
Antioxidant capacity
Time frame: baseline and 8 weeks
Lipid profile
Time frame: baseline and 8 weeks
Endothelial function
Time frame: baseline and 8 weeks
Inflammation
Time frame: baseline and 8 weeks
Creatinine
Time frame: baseline and 8 weeks
Lactate
Time frame: baselina and 8 weeks
Creatine kinase
Time frame: baseline and 8 weeks
Questionnaire of Quality of life
Time frame: baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Pilates in people with Hypertension, run by Universidade Federal de Santa Maria 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?
The sponsor lists 2 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 1 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline casual systolic blood pressure at 8 weeks (time frame: baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 1 May 2020.