Reduce Cardiovascular Risk in Women Through Tai Chi Intervention

NCT ID: NCT01467544

Last Updated: 2013-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Cardiometabolic Risk; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

wait list control group

After completing time three data collection, wait-listed participants will be provided with the complete tai chi intervention (8 weeks).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Tai Chi intervention group

This participant group completes the 8-week tai chi group intervention.

Group Type: EXPERIMENTAL

Tai Chi class

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo Lynne W Robins, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

P30NR011403

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13605

Identifier Type: -

Identifier Source: org_study_id