Tai Chi and Wellness Education for Older Veterans

NCT ID: NCT03624868

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2022-04-20

Brief Summary

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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

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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.

Conditions

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Physical Activity PTSD Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to Tai Chi or Wellness Education
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Pre- and Post-intervention assessments will be conducted by an assessor who is blind to study condition.

Study Groups

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Tai Chi

A Tai Chi protocol designed for use with older veterans will be used. In each class, the instructor will explain exercise theory and procedures of Tai Chi and review printed materials. Every session will include the following components: (1) warm-up and a review of Tai Chi principles; (2) Tai Chi movement; (3) breathing techniques; (4) relaxation. Each component of the program derives from classical Yang style Tai Chi 108 posture. The Tai Chi instructor will also encourage patients to practice for at least 30 minutes a day at home and to complete daily logs indicating the amount of time that they spent engaged in Tai Chi exercise. Discussion of goal-setting regarding home practice and solutions to potential barriers will be included.

Group Type EXPERIMENTAL

Tai Chi

Intervention Type BEHAVIORAL

See above description

Wellness Education

The wellness education intervention will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives). The Whole Health program focuses on teaching mindful awareness to promote behavioral changes that are consistent with an individual's health goals. Components of the Whole Health model include working the body, surroundings, personal development, food and drink, recharge, family, friends and coworkers, spirit and soul, and power of the mind. Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. Goal-setting using the SMART goals model, with regards to health and wellness, and discussions about ways to address potential barriers will be included in this condition.

Group Type ACTIVE_COMPARATOR

Wellness Education

Intervention Type BEHAVIORAL

See above description

Interventions

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Tai Chi

See above description

Intervention Type BEHAVIORAL

Wellness Education

See above description

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

VA Boston Healthcare System

FED

Sponsor Role lead

Responsible Party

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Anica Pless Kaiser

Clinical Research Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anica Pless Kaiser, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System and Boston University School of Medicine

Locations

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VA Boston Healthcare System

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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P30AG048785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30AG048785

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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