HypertensionNCT04226235
Acute Effects of Vinyasa Yoga on Vascular Function
A study testing Yoga session in people with Hypertension, run by Texas State University at 1 site in United States.
Trial summary
The purpose of this investigation was to determine the acute effects of vinyasa yoga on arterial stiffness, wave reflection, and blood markers in normo- and hyper-tensive adults. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Yoga session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2018to 1 Jun 2019
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having normal (systolic blood pressure <120 mm Hg with a diastolic <80 mm Hg) or elevated blood pressure (systolic blood pressure 120-129 mm Hg) or stage 1 hypertension (systolic blood pressure 130-139 mm Hg or a diastolic blood pressure 80-89 mm Hg).
- Must have had at least 3 months of prior yoga experience.
Who cannot join
- A history of cardiovascular disease or cardiac events, pregnancy, infection within the last 4 weeks, chronic obstructive pulmonary disease (COPD), endocrine or renal disease, metabolic disorders, or debilitating muscular, joint and bone injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Yoga on Arterial Stiffness, Wave Reflection, and Blood Markers in Normotensive and Hypertensive Adults
The purpose of this investigation was to determine the acute effects of vinyasa yoga on arterial stiffness, wave reflection, and blood markers in normo- and hyper-tensive adults. To address this aim, fifteen normotensive adults and 15 adults with elevated blood pressure or stage 1 hypertension with a minimum of 3 months of yoga practice experience were enrolled. Carotid-femoral pulse wave velocity (cf-PWV), augmentation index (AIx), lipid profile, and glucose concentrations were assessed at baseline and immediately following a 1-hour vinyasa yoga session.
- Conditions
- Hypertension
- Being tested
- Yoga session
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga sessionBehavioural
a 1-hour yoga session was completed by all participants following a DVD.
| Study group | Role | What they receive |
|---|---|---|
| 1-hour vinyasa yoga session | Experimental | One hour of vinyasa yoga was completed by all participants while following a DVD. Receives: Behavioral: Yoga session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
Carotid-femoral pulse wave velocity
Measured: Once before the yoga session
Arterial stiffness
Carotid-femoral pulse wave velocity
Measured: Once immediately after the 1-hour yoga session
Wave reflection
Augmentation index
Measured: Once before the yoga session
Wave reflection
Augmentation index
Measured: Once immediately after the 1-hour yoga session
Secondary outcomes (2)
Lipid profile
Blood samples obtained via finger stick and analyzed for total-, LDL-, and HDL-cholesterol and triglyceride concentrations using reflectance photometry.
Measured: Once before the yoga session
Lipid profile
Blood samples obtained via finger stick and analyzed for total-, LDL-, and HDL-cholesterol and triglyceride concentrations using reflectance photometry.
Measured: Once immediately after the 1-hour yoga session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start14 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226235
- Sponsor's protocol ID
- 530
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Yoga on Arterial Stiffness, Wave Reflection, and Blood Markers in Normotensive and Hypertensive Adults
- ClinicalTrials.gov ID
- NCT04226235
- Acronym / sponsor ID
- 530
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 13 Jan 2020 (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.
The purpose of this investigation was to determine the acute effects of vinyasa yoga on arterial stiffness, wave reflection, and blood markers in normo- and hyper-tensive adults. To address this aim, fifteen normotensive adults and 15 adults with elevated blood pressure or stage 1 hypertension with a minimum of 3 months of yoga practice experience were enrolled. Carotid-femoral pulse wave velocity (cf-PWV), augmentation index (AIx), lipid profile, and glucose concentrations were assessed at baseline and immediately following a 1-hour vinyasa yoga session.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1-hour vinyasa yoga session | Experimental | Behavioral: Yoga sessionOne hour of vinyasa yoga was completed by all participants while following a DVD. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having normal (systolic blood pressure <120 mm Hg with a diastolic <80 mm Hg) or elevated blood pressure (systolic blood pressure 120-129 mm Hg) or stage 1 hypertension (systolic blood pressure 130-139 mm Hg or a diastolic blood pressure 80-89 mm Hg).
- Must have had at least 3 months of prior yoga experience.
Key exclusion criteria (1 listed)
- A history of cardiovascular disease or cardiac events, pregnancy, infection within the last 4 weeks, chronic obstructive pulmonary disease (COPD), endocrine or renal disease, metabolic disorders, or debilitating muscular, joint and bone injury.
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 |
|---|---|---|
| Yoga sessiona 1-hour yoga session was completed by all participants following a DVD. | Behavioural | 1-hour vinyasa yoga session |
Primary outcome
Arterial stiffness
Time frame: Once before the yoga session
Carotid-femoral pulse wave velocity
Arterial stiffness
Time frame: Once immediately after the 1-hour yoga session
Carotid-femoral pulse wave velocity
Wave reflection
Time frame: Once before the yoga session
Augmentation index
Wave reflection
Time frame: Once immediately after the 1-hour yoga session
Augmentation index
2 secondary outcomes
Lipid profile
Time frame: Once before the yoga session
Lipid profile
Time frame: Once immediately after the 1-hour yoga session
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 13 Jan 2020.
- Individual participant dataSharing planned: No
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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 Yoga session in people with Hypertension, run by Texas State 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 2 inclusion and 1 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 13 Jan 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: Once before the yoga session). The study lists 4 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 13 Jan 2020.