- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907384
Mat Pilates and Vascular Function in Obese Females
October 29, 2020 updated by: Alexei Wong, Marymount University
The Effects of Mat Pilates Training on Vascular Function in Obese Premenopausal Women With Elevated Blood Pressure
Obesity is associated with progressive decreases in arterial health and function.
It is crucial to prevent or reduce the negative effects of aging on the vasculature by implementing appropriate lifestyle interventions, such as exercise training.
We examined the effects of a Mat Pilates training (MPT) regimen on arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), wave reflection (AIx) and endothelial function in obese premenopausal women with elevated BP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Using a parallel experimental design, participants were randomly assigned to either MPT (n=14) or non-exercising control group (n=14) for 12 weeks.
Participant in the MPT group trained 3 days/week .
Participants' brachial to ankle PWV (baPWV), systolic and diastolic BP, AIx, plasma NO levels were measured at baseline and after 20 weeks of their assigned intervention.
Study Type
Interventional
Enrollment (Actual)
28
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
-
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Nebraska
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Omaha, Nebraska, United States, 68022
- University of Nebraska
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-
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 to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- body mass index 30-40 kg/m2
- <1 h of regular exercise per week in the previous year
- systolic/diastolic BP: 120-129mm Hg systolic BP and ˂ 80 mm Hg for diastolic BP
- Nonsmokers
Exclusion Criteria:
- body mass index ˂30 and ≥40 kg/m2
- chronic diseases
- taking oral contraceptives
- pregnancy
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Participants in the non-exercising control group did not participate in a supervised exercise program and visited the laboratory at the same frequency as participants in the swim intervention and underwent recreational activities such as board games
|
|
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Experimental: Mat Pilates training
The MPT group participated in 3-one hour supervised training sessions per week for 12 weeks.
All MP sessions were performed in nonconsecutive days.
The MP sessions were divided into the following stages: initial warm up and stretching (10 min), general conditioning consisting of MP exercises (40 min) and stretching and cooling down (10 min).
The participants performed 12 basic MP exercises (one set of 6-10 repetitions was performed per exercise).
Breathing, a core principle of MP, was performed by forced but controlled inspirations and exhalations, while relaxing and contracting the abdomen, respectively.
All sessions were supervised by a certified MP instructor.
|
This group completed 12-weeks of training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial Stiffness
Time Frame: 12 weeks
|
via Pulse Wave Velocity
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic and Diastolic Blood Pressure
Time Frame: 12 weeks
|
Automatic BP monitor
|
12 weeks
|
|
Pressure Wave Reflection
Time Frame: 12 weeks
|
via Augmentation Index
|
12 weeks
|
|
Endothelial Function
Time Frame: 12 weeks
|
via plasma nitric oxide
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
April 1, 2018
Primary Completion (Actual)
October 30, 2018
Study Completion (Actual)
October 30, 2018
Study Registration Dates
First Submitted
March 26, 2019
First Submitted That Met QC Criteria
April 6, 2019
First Posted (Actual)
April 9, 2019
Study Record Updates
Last Update Posted (Actual)
October 30, 2020
Last Update Submitted That Met QC Criteria
October 29, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1342019
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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