NCT03624868

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 29, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

August 3, 2018

Last Update Submit

March 31, 2025

Conditions

Keywords

Tai ChiOlder VeteransPhysical activityPTSD

Outcome Measures

Primary Outcomes (2)

  • Senior Fitness Test

    Physical fitness

    at pre-intervention and at post-intervention, about 12 weeks

  • Posttraumatic Stress Disorder Checklist (PCL-5)

    PTSD checklist

    at pre-intervention and at post-intervention, about 12 weeks

Secondary Outcomes (1)

  • International Physical Activity Questionnaire

    at pre-intervention and at post-intervention, about 12 weeks

Study Arms (2)

Tai Chi

EXPERIMENTAL

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.

Behavioral: Tai Chi

Wellness Education

ACTIVE COMPARATOR

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.

Behavioral: Wellness Education

Interventions

Tai ChiBEHAVIORAL

See above description

Tai Chi

See above description

Wellness Education

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Motor ActivityStress Disorders, Post-TraumaticPersonal Satisfaction

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

BehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Anica Pless Kaiser, PhD

    VA Boston Healthcare System and Boston University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Pre- and Post-intervention assessments will be conducted by an assessor who is blind to study condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to Tai Chi or Wellness Education
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Psychologist

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 10, 2018

Study Start

January 29, 2019

Primary Completion

January 29, 2022

Study Completion

April 20, 2022

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations