Reduce Cardiovascular Risk in Women Through Tai Chi Intervention

Cardiovascular Disease Clinical Trial

Official title:

Exploring the Effects of Tai Chi on Cardiometabolic Risk in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467544
• Other study ID #: 13605
• Secondary ID: P30NR011403
• Status: Completed
• Phase: N/A
• First received: October 27, 2011
• Last updated: May 17, 2013
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiometabolic Risk
• Cardiovascular Disease
• Cardiovascular Diseases

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of the intervention		8weeks intervention & post-class focus group	Yes
Secondary	Identify potential indicators of intervention effectiveness (change in PNI measures).		baseline	Yes
Secondary	Identify potential indicators of intervention effectiveness (change in PNI measures).		8 Weeks	Yes
Secondary	Identify potential indicators of intervention effectiveness (change in PNI measures).		4 Months	Yes