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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03624868
Other study ID # P30AG048785
Secondary ID P30AG048785
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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