NCT01467544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

1.5 years

First QC Date

October 27, 2011

Last Update Submit

May 17, 2013

Conditions

Keywords

Tai Chi

Outcome Measures

Primary Outcomes (1)

  • Feasibility and acceptability of the intervention

    8weeks intervention & post-class focus group

Secondary Outcomes (3)

  • Identify potential indicators of intervention effectiveness (change in PNI measures).

    baseline

  • Identify potential indicators of intervention effectiveness (change in PNI measures).

    8 Weeks

  • Identify potential indicators of intervention effectiveness (change in PNI measures).

    4 Months

Study Arms (2)

wait list control group

NO INTERVENTION

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

Tai Chi intervention group

EXPERIMENTAL

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

Other: Tai Chi class

Interventions

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.

Tai Chi intervention group

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • premenopausal women
  • able to read and speak English
  • self-reported histories of CVD in first- or second-degree relatives

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jo Lynne W Robins, Ph.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2011

First Posted

November 8, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations