- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03214016
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pilates method group
The participants will do Mat Pilates.
|
1 hour of Mat Pilates, 2 times a week, during 8 weeks.
Other Names:
|
ACTIVE_COMPARATOR: Aerobic training group
The participants will do aerobic exercise on treadmill.
|
1 hour of aerobic training on a treadmill, 3 times a week, during 8 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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.
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)
August 20, 2017
Primary Completion (ACTUAL)
May 30, 2018
Study Completion (ACTUAL)
August 31, 2018
Study Registration Dates
First Submitted
July 3, 2017
First Submitted That Met QC Criteria
July 9, 2017
First Posted (ACTUAL)
July 11, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 1, 2020
Last Update Submitted That Met QC Criteria
April 29, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
Clinical Trials on Pilates
-
University of Colorado, Colorado SpringsUniversity of Illinois at Urbana-ChampaignCompleted
-
Universidade Gama FilhoUnknown
-
Universidade Cidade de Sao PauloCompleted
-
Pontificia Universidade Católica do Rio Grande...Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Amparo... and other collaboratorsCompletedAging | Mobility Limitation | Postural BalanceBrazil
-
University of JaenCompletedLow Back Pain | Mind-body Exercise | Pilates, Core Stability | Pilates ExerciseSpain
-
Universidade Cidade de Sao PauloUnknown
-
Universidad de AntioquiaCompletedHealthy VolunteersColombia
-
Michele de Aguiar ZacariaRecruiting
-
Tarsus UniversityRecruiting
-
National University of Ireland, Galway, IrelandCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Completed