NCT05598073

Brief 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; 3) compare isokinetic muscular strength between racial groups; and 4) determine if correlations exist between these measures.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
Last Updated

October 28, 2022

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

January 8, 2020

Last Update Submit

October 25, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • Arterial stiffness

    Cardio-ankle vascular index

    Once at baseline

  • Ambulatory blood pressure

    24 hours of ambulatory blood pressure monitoring

    Once at baseline

  • Isokinetic strength

    Isokinetic leg extension and flexion strength assessments at 60,120,210,300, and 400 degrees per second

    Once at baseline

  • Inflammatory markers

    Blood samples will be obtained and analyzed for interleukin-6 and tumor necrosis factor alpha

    Once at baseline

  • Inflammatory markers

    Blood samples will be obtained and analyzed for interleukin-6 and tumor necrosis factor alpha

    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

    Once immediately after the 1-hour yoga session

Study Arms (1)

1-hour vinyasa yoga session

EXPERIMENTAL

Participants will complete a 1-hour vinyasa yoga DVD.

Behavioral: Vinyasa yoga session

Interventions

One hour of vinyasa yoga will be completed.

1-hour vinyasa yoga session

Eligibility Criteria

Age18 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stacy Hunter

San Marcos, Texas, 78666, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

October 28, 2022

Study Start

January 15, 2020

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

October 28, 2022

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations