Reduce Cardiovascular Risk in Women Through Tai Chi Intervention

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01467544
First received: October 27, 2011
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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 Intervention
Cardiometabolic Risk
Cardiovascular Disease
Other: Tai Chi class

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Exploring the Effects of Tai Chi on Cardiometabolic Risk in Women

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Feasibility and acceptability of the intervention [ Time Frame: 8weeks intervention & post-class focus group ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Identify potential indicators of intervention effectiveness (change in PNI measures). [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Identify potential indicators of intervention effectiveness (change in PNI measures). [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
  • Identify potential indicators of intervention effectiveness (change in PNI measures). [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]

Enrollment: 96
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467544

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Jo Lynne W Robins, Ph.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01467544     History of Changes
Other Study ID Numbers: 13605, P30NR011403
Study First Received: October 27, 2011
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Tai Chi

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014