ObeseNCT03907384
Mat Pilates and Vascular Function in Obese Females
A study testing Mat Pilates training in people with Obese and Elevated Blood Pressure, run by Marymount University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obese, Elevated Blood Pressure
- What is being tested?
- Mat Pilates training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 30 Oct 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- body mass index ˂30 and ≥40 kg/m2
- chronic diseases
- taking oral contraceptives
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obese, Elevated Blood Pressure
- Being tested
- Mat Pilates training
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mat Pilates trainingBehavioural
This group completed 12-weeks of training
| Study group | Role | What they receive |
|---|---|---|
| Mat Pilates training | Experimental | 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. Receives: Behavioral: Mat Pilates training |
| Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
via Pulse Wave Velocity
Measured: 12 weeks
Secondary outcomes (3)
Systolic and Diastolic Blood Pressure
Automatic BP monitor
Measured: 12 weeks
Pressure Wave Reflection
via Augmentation Index
Measured: 12 weeks
Endothelial Function
via plasma nitric oxide
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Apr 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marymount University
- Sponsor type
- University, hospital or other
- Collaborators
- Busan University, Texas Tech University, University of Isfahan
- Responsible party
- Principal investigator, Alexei Wong, Marymount University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907384
- Sponsor's protocol ID
- 1342019
- Status last verified
- Oct 2020
- First submitted
- 26 Mar 2019
- Last updated
- 30 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong A, Figueroa A, Fischer SM, Bagheri R, Park SY. The Effects of Mat Pilates Training on Vascular Function and Body Fatness in Obese Young Women With Elevated Blood Pressure. Am J Hypertens. 2020 May 21;33(6):563-569. doi: 10.1093/ajh/hpaa026.
PubMed 32236522
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mat Pilates Training on Vascular Function in Obese Premenopausal Women With Elevated Blood Pressure
- ClinicalTrials.gov ID
- NCT03907384
- Acronym / sponsor ID
- 1342019
- Conditions
- Obese, Elevated Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Marymount UniversityUniversity, hospital or other
- Collaborators
- Busan University, Texas Tech University, University of Isfahan
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 9 Apr 2019 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mat Pilates training | Experimental | Behavioral: Mat Pilates trainingThe 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. |
| Control | No intervention | –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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- body mass index ˂30 and ≥40 kg/m2
- chronic diseases
- taking oral contraceptives
- pregnancy
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 Pilates trainingThis group completed 12-weeks of training | Behavioural | Mat Pilates training |
Primary outcome
Arterial Stiffness
Time frame: 12 weeks
via Pulse Wave Velocity
3 secondary outcomes
Systolic and Diastolic Blood Pressure
Time frame: 12 weeks
Pressure Wave Reflection
Time frame: 12 weeks
Endothelial Function
Time frame: 12 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 30 Oct 2020.
- Derived from this study: PubMed 32236522Wong A, Figueroa A, Fischer SM, Bagheri R, Park SY. The Effects of Mat Pilates Training on Vascular Function and Body Fatness in Obese Young Women With Elevated Blood Pressure. Am J Hypertens. 2020 May 21;33(6):563-569. doi: 10.1093/ajh/hpaa026.
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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 Mat Pilates training in people with Obese and Elevated Blood Pressure, run by Marymount University at 1 site in United States.
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 4 inclusion and 4 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 30 Oct 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 United States. 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?
Arterial Stiffness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03907384, which also lists 1 linked publication.
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 30 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.