Clinical trial NCT01467544: Reduce Cardiovascular Risk in Women Through Tai Chi Intervention
Official title: Exploring the Effects of Tai Chi on Cardiometabolic Risk in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk
Cardiovascular Disease
Keywords: Tai Chi
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-11-08
Enrollment: 96
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility and acceptability of the intervention
timeFrame: 8weeks intervention & post-class focus group
Secondary outcomes:
measure: Identify potential indicators of intervention effectiveness (change in PNI measures).
timeFrame: baseline
measure: Identify potential indicators of intervention effectiveness (change in PNI measures).
timeFrame: 8 Weeks
measure: Identify potential indicators of intervention effectiveness (change in PNI measures).
timeFrame: 4 Months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jo Lynne W Robins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: