Clinical trial NCT03624868: Tai Chi and Wellness Education for Older Veterans
Official title: A Randomized Pilot Trial of Tai Chi Compared to Wellness Education for Older Veterans
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Physical Activity
PTSD
Satisfaction
Keywords: Tai Chi
Older Veterans
Physical activity
PTSD
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
Collaborators: name: National Institute on Aging (NIA)
name: Boston University
First posted: 2018-08-10
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to Tai Chi or Wellness Education
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Senior Fitness Test
timeFrame: at pre-intervention and at post-intervention, about 12 weeks
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: at pre-intervention and at post-intervention, about 12 weeks
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: at pre-intervention and at post-intervention, about 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System and Boston University School of Medicine
name: Anica Pless Kaiser, PhD
role: PRINCIPAL_INVESTIGATOR
References: