CClinicalTrials.gg
CompletedNCT01467544Updated May 21, 2013

Reduce Cardiovascular Risk in Women Through Tai Chi Intervention

An interventional study of Tai Chi class in Cardiometabolic Risk and Cardiovascular Disease, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to female participants aged 35 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-05-21.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
35 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiometabolic Risk
  • Cardiovascular Disease

Keywords

  • Tai Chi
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 96 is close to the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 50 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • 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

Interventions

  • OtherTai 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.

06

What researchers measure

Primary outcomes

  1. Feasibility and acceptability of the intervention

    Time frame: 8weeks intervention & post-class focus group

Secondary outcomes

  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

07

Study locations

1 site
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01467544
Lead sponsor
Virginia Commonwealth University
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Sponsor
First posted
Nov 8, 2011
Start date
Jun 2011
Primary completion
Dec 2012
Completion
Dec 2012
Last update
May 21, 2013

Study contacts

Jo Lynne W Robins, Ph.D.
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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