Reduce Cardiovascular Risk in Women Through Tai Chi Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01467544
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : May 21, 2013
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
Tai chi intervention may lead to relaxation and could potentially reduce the risk of cardiovascular disease. This project entails a comprehensive and innovative approach for understanding, measuring, and potentially reducing cardiovascular risk in women. The goal of this area of research is to reduce cardiovascular risk and perhaps reduce illness and death.

Condition or disease Intervention/treatment
Cardiometabolic Risk Cardiovascular Disease Other: Tai Chi class

Detailed Description:
Cardiovascular disease (CVD) is the leading cause of death in the United States. Historically, CVD has been under diagnosed and inadequately treated in women related to issues of gender bias, lack of public and medical awareness of its prevalence, and its unique presenting symptomatology. Despite increasing awareness, as well as better diagnostics and treatment, women are still more likely than men to present with advanced disease and experience higher CVD-related morbidity and mortality. Given these facts, prevention of CVD is critical. Cardiometabolic risk (CMR) is a relatively new term for a set of risk factors that, when viewed together, are indicators of overall risk for developing CVD. CMR is useful for assessing, modifying, and ultimately preventing the development of CVD. Prevention of CVD in women may best be achieved by early identification and treatment of evolving CMR. Central or abdominal obesity, reflecting the presence of visceral adipose tissue and evidenced by increased waist circumference, has been shown to be a significant predictor of CVD. In this PNI-based model of CMR and fatigue, abdominal adiposity and fatigue are products of allostatic load. Resulting from cumulative wear and tear, fatigue gives rise to dysregulation of metabolic processes, ultimately resulting in subjective symptomatology and disease risk. Additionally, fatigue often accompanies metabolic changes, potentiating a trajectory of CMR related to decreased physical activity and self-care. Tai chi may enhance relaxation and could potentially reduce CMR. The specific aims of this project are to refine a tai chi intervention using a wait-list pretest-posttest design with repeated measures. Feasibility and acceptability of the intervention and identification of potential indicators of effectiveness also will be assessed. Additionally, a PNI-based model of fatigue and CMR will be further refined. The first aim will be analyzed using a mixed effects model. The second specific aim, to refine a PNI-based model of fatigue and CMR, will be examined using descriptive statistics, graphical methods and pairwise correlations and, as a second step, variable reduction methods including factor analysis, principle component analysis and canonical correlation analysis. The project is based on a theoretically and scientifically sound framework to investigate a more comprehensive, sensitive, and innovative model for understanding, measuring, and potentially reducing CMR in women. With further studies, the goal of this line of research is to reduce CMR and perhaps reduce morbidity and mortality related to CVD.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exploring the Effects of Tai Chi on Cardiometabolic Risk in Women
Study Start Date : June 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Arm Intervention/treatment
No Intervention: wait list control group
After completing time three data collection, wait-listed participants will be provided with the complete tai chi intervention (8 weeks).
Experimental: Tai Chi intervention group
This participant group completes the 8-week tai chi group intervention.
Other: Tai Chi class
The 8-week tai chi group intervention will be lead by Project PI. A focused short form of tai chi involving 12 movements will be used in this project. Each of 8 weekly 60-minute sessions will begin with a 10-minute guided meditation session. Movements learned the previous week will be reviewed prior to introducing new movements. Training DVDs will be produced and provided to participants for weekly and ongoing practice of the techniques.

Primary Outcome Measures :
  1. Feasibility and acceptability of the intervention [ Time Frame: 8weeks intervention & post-class focus group ]

Secondary Outcome Measures :
  1. Identify potential indicators of intervention effectiveness (change in PNI measures). [ Time Frame: baseline ]
  2. Identify potential indicators of intervention effectiveness (change in PNI measures). [ Time Frame: 8 Weeks ]
  3. Identify potential indicators of intervention effectiveness (change in PNI measures). [ Time Frame: 4 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • premenopausal women
  • able to read and speak English
  • self-reported histories of CVD in first- or second-degree relatives

Exclusion Criteria:

  • previous diagnosis of CVD, DM, uncontrolled or severe hypertension (defined as >180/120),
  • LDL-C greater than or equal to 160,
  • fasting blood glucose greater than or equal to 126,
  • morbid obesity (BMI > 40), or
  • unstable major depressive disorder.
  • taken corticosteroids within 30 days and 72 hours of inhaled or nasal steroids of data collection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01467544

United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute of Nursing Research (NINR)
Principal Investigator: Jo Lynne W Robins, Ph.D. Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University Identifier: NCT01467544     History of Changes
Other Study ID Numbers: 13605
P30NR011403 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Virginia Commonwealth University:
Tai Chi

Additional relevant MeSH terms:
Cardiovascular Diseases