NCT03993184

Brief Summary

This study will examine the effects of a 12 week hot yoga intervention on vascular health in adults between the ages of 20 and 65. The investigators are seeking individuals with slightly elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Participants will receive 12 weeks of free yoga for their participation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

March 6, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 27, 2022

Status Verified

March 1, 2021

Enrollment Period

3.6 years

First QC Date

March 6, 2018

Last Update Submit

October 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Averages in ambulatory blood pressure and vascular function

    Blood pressure monitoring using an arm cuff for one full day before and after the intervention

    24 hours

Secondary Outcomes (3)

  • Perceived stress

    5 minutes

  • Brachial artery endothelial function

    15 minutes

  • Arterial Stiffness

    10 minutes

Study Arms (3)

90-minute Hot Yoga Classes

EXPERIMENTAL

This group will complete 3, 90-minute hot yoga classes weekly for 12 weeks.

Behavioral: Hot Yoga

60-minute Hot Yoga Classes

EXPERIMENTAL

This group will complete 3, 60-minute hot yoga classes weekly for 12 weeks.

Behavioral: Hot Yoga

Control

NO INTERVENTION

This group will maintain their current physical activity for 12 weeks.

Interventions

Hot YogaBEHAVIORAL

Bikram or hot yoga is a standardized series of 26 postures with two breathing exercises. Classes will be performed at local yoga studios in Austin, Texas and participants will be required to sign in for each session. All participants will receive 12 weeks of free classes for their participation.

60-minute Hot Yoga Classes90-minute Hot Yoga Classes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elevated blood pressure or stage I hypertension;
  • sedentary (not currently exercising regularly);
  • not currently taking blood pressure medications.

You may not qualify if:

  • Pregnancy;
  • renal disease;
  • prior heart attack;
  • known coronary artery disease;
  • history of stroke,
  • heart failure, cardiac arrhythmias or chronic obstructive pulmonary disease (COPD);
  • recent chest pain;
  • heat intolerance;
  • body mass index of 40 or more.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas State University

San Marcos, Texas, 78666, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Monica Gonzales

    Texas State University IRB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2018

First Posted

June 20, 2019

Study Start

April 17, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 27, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations