Cardiovascular and Immune Responses to YogaNCT05598073
Racial Differences in Yoga-Induced Responses
A study testing Vinyasa yoga session in people with Cardiovascular and Immune Responses to Yoga, run by Texas State University at 1 site in United States.
Trial summary
The purpose of this study is to 1) determine whether racial differences are evident in resting arterial stiffness and ambulatory blood pressure between African Americans and Caucasians 2) compare heart rate, blood pressure and cytokine production responses to exercise (yoga) between African Americans and Caucasians… Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular and Immune Responses to Yoga
- What is being tested?
- Vinyasa yoga session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 1 Jul 2020
- 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 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men between the ages of 18 and 39 (25 African American and 25 Caucasian) that are not professional or collegiate athletes
- Must exercise at least 3 days per week and have no more than 1 month of yoga practice.
Who cannot join
- Having stage 2 hypertension (>130 mmHg for systolic / >90 mmHg for diastolic) or higher or having taken BP medications within the 3 months prior to testing
- Infection within the previous 4 weeks
- Known renal disease
- Prior myocardial infarction
- Known coronary artery disease
- Personal history of stroke
Show all 19Show fewer
- Heart failure
- Cardiac arrhythmias
- Chronic obstructive pulmonary disease
- Recent chest pain or dyspnea
- Orthopedic limitations that preclude the execution of yoga postures
- Current insulin dependence
- Chronic inflammatory conditions
- Blindness or deafness as participants will need to follow a yoga DVD in order to complete the session
- Having practiced yoga for more than 1 month
- Having parents of mixed racial backgrounds (i.e. both parents must be Caucasian or African American)
- Not being African American or Caucasian
- Being a professional or collegiate athlete
- Being insulin-dependent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Racial Differences in Yoga-Induced Cardiovascular and Immune Responses
The purpose of this study is to 1) determine whether racial differences are evident in resting arterial stiffness and ambulatory blood pressure between African Americans and Caucasians 2) compare heart rate, blood pressure and cytokine production responses to exercise (yoga) between African Americans and Caucasians; 3) compare isokinetic muscular strength between racial groups; and 4) determine if correlations exist between these measures.
- Being tested
- Vinyasa yoga session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinyasa yoga sessionBehavioural
One hour of vinyasa yoga will be completed.
| Study group | Role | What they receive |
|---|---|---|
| 1-hour vinyasa yoga session | Experimental | Participants will complete a 1-hour vinyasa yoga DVD. Receives: Behavioral: Vinyasa yoga session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
Cardio-ankle vascular index
Measured: Once at baseline
Ambulatory blood pressure
24 hours of ambulatory blood pressure monitoring
Measured: Once at baseline
Isokinetic strength
Isokinetic leg extension and flexion strength assessments at 60,120,210,300, and 400 degrees per second
Measured: Once at baseline
Inflammatory markers
Blood samples will be obtained and analyzed for interleukin-6 and tumor necrosis factor alpha
Measured: Once at baseline
Inflammatory markers
Blood samples will be obtained and analyzed for interleukin-6 and tumor necrosis factor alpha
Measured: Once 30 minutes into the 1-hour yoga session
Inflammatory markers
Blood samples will be obtained and analyzed for interleukin-6 and tumor necrosis factor alpha
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 posted28 Oct 2022
- Study start15 Jan 2020 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Why it stopped: The student leading the project decided not to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular and Immune Responses to YogaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT05598073
- Sponsor's protocol ID
- 6877
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 28 Oct 2022
- 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 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Differences in Yoga-Induced Cardiovascular and Immune Responses
- ClinicalTrials.gov ID
- NCT05598073
- Acronym / sponsor ID
- 6877
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The student leading the project decided not to continue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 28 Oct 2022 (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 study is to 1) determine whether racial differences are evident in resting arterial stiffness and ambulatory blood pressure between African Americans and Caucasians 2) compare heart rate, blood pressure and cytokine production responses to exercise (yoga) between African Americans and Caucasians; 3) compare isokinetic muscular strength between racial groups; and 4) determine if correlations exist between these measures.
Study design
- Primary purpose
- Basic science
- 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: Vinyasa yoga sessionParticipants will complete a 1-hour vinyasa yoga DVD. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men between the ages of 18 and 39 (25 African American and 25 Caucasian) that are not professional or collegiate athletes
- Must exercise at least 3 days per week and have no more than 1 month of yoga practice.
Key exclusion criteria (19 listed)
- Having stage 2 hypertension (>130 mmHg for systolic / >90 mmHg for diastolic) or higher or having taken BP medications within the 3 months prior to testing
- Infection within the previous 4 weeks
- Known renal disease
- Prior myocardial infarction
- Known coronary artery disease
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 |
|---|---|---|
| Vinyasa yoga sessionOne hour of vinyasa yoga will be completed. | Behavioural | 1-hour vinyasa yoga session |
Primary outcome
Arterial stiffness
Time frame: Once at baseline
Cardio-ankle vascular index
Ambulatory blood pressure
Time frame: Once at baseline
24 hours of ambulatory blood pressure monitoring
Isokinetic strength
Time frame: Once at baseline
Isokinetic leg extension and flexion strength assessments at 60,120,210,300, and 400 degrees per second
Inflammatory markers
Time frame: Once at baseline
Blood samples will be obtained and analyzed for interleukin-6 and tumor necrosis factor alpha
Inflammatory markers
Time frame: Once 30 minutes into the 1-hour yoga session
Blood samples will be obtained and analyzed for interleukin-6 and tumor necrosis factor alpha
Inflammatory markers
Time frame: Once immediately after the 1-hour yoga session
Blood samples will be obtained and analyzed for interleukin-6 and tumor necrosis factor alpha
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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 Vinyasa yoga session in people with Cardiovascular and Immune Responses to Yoga, 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 19 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: withdrawn, as of the sponsor's last update on 28 Oct 2022. 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 was withdrawn before enrolling participants, so there are no results.
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 at baseline). The study lists 6 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 28 Oct 2022.