Tai Chi and Wellness Education for Older Veterans

Physical Activity Clinical Trial

Official title:

A Randomized Pilot Trial of Tai Chi Compared to Wellness Education for Older Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03624868
• Other study ID #: P30AG048785
• Secondary ID: P30AG048785
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: December 2021

Study information

• Verified date: May 2020
• Source: VA Boston Healthcare System
• Contact: Anica Pless Kaiser, PhD
• Phone: 857-364-5309
• Email: Anica.PlessKaiser[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to examine physical fitness, PTSD, and satisfaction with a Tai Chi intervention for older (aged 60 and older), sedentary, trauma-exposed veterans, in comparison to a wellness education attention control. Secondary outcomes include physical activity, depression, well-being, late-onset stress, functional status, cognition, and exercise self-efficacy. Outcomes will be examined pre- to post-intervention and in comparison to the control condition.

Description:

The proposed study will consist of a pilot trial of three 12-week, 24-session Tai Chi intervention groups compared with three 12-week, 24-session wellness education control groups. Participants will be randomly assigned in blocks of 14 to either the Tai Chi or the wellness education condition, half to each. Veterans who do not agree to randomization will be excluded. Baseline and post-intervention assessments will be completed, and it is anticipated that 42 individuals will complete baseline assessments. After the final sessions, participants will be asked to provide feedback to investigators via questionnaires, a focus group discussion, and individual interviews utilizing open-ended questions. Information collected from participants will be integrated and utilized for presentations/manuscript preparation, as well as to refine protocols for use in future research.

Potentially eligible veterans who have expressed interest in the study will be called and research staff will describe all aspects of the study. Research staff will answer any questions, and then obtain oral consent for screening for eligibility criteria in the medical record. Study staff will then go through the eligibility criteria over the telephone and schedule a baseline assessment as appropriate. Participants will be mailed information about the time and location for the initial baseline assessment and the class schedule and location to which they are assigned. They will also receive phone calls with this information. Information collected during the telephone screening (prior to completion of the Informed Consent Form) will be collected and retained with the prospective participant's verbal permission. This information will be kept separate from identifying information (names, addresses, and telephone numbers). Some information collected from the electronic medical record will be recorded in order to document inclusion and exclusion criteria.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age 60 or older

• Have experienced a traumatic event (determined through telephone screening)

• English-speaking

• Considered to be sedentary

• Not planning to relocate in the next three months

• Reports ability to attend group sessions.

Exclusion Criteria:

• Lacks the capacity to provide consent

• Unable to stand for the duration of a 60-minute Tai Chi intervention

• Has major medical, psychiatric, or neurological disorder or has a moderate or severe traumatic brain injury,

• Change in psychotropic or pain medication during the past month

• Regular current Tai Chi, formal mindfulness meditation program, or yoga practice

• Unwillingness to be randomly assigned to group

• Engagement in another treatment study that might impact findings

Related Conditions & MeSH terms

• Physical Activity
• PTSD
• Satisfaction

Intervention

Behavioral:
• Tai Chi
See above description
• Wellness Education
See above description

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
VA Boston Healthcare System	Boston University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Senior Fitness Test	Physical fitness	at pre-intervention and at post-intervention, about 12 weeks
Primary	Posttraumatic Stress Disorder Checklist (PCL-5)	PTSD checklist	at pre-intervention and at post-intervention, about 12 weeks
Secondary	International Physical Activity Questionnaire	Physical activity	at pre-intervention and at post-intervention, about 12 weeks