Tai Chi and Wellness Education for Older Veterans

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

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.

Study Overview

• Status: Unknown
• Conditions: PTSD; Physical Activity; Satisfaction
• Intervention / Treatment: Behavioral: Tai Chi; Behavioral: Wellness Education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anica Pless Kaiser, PhD; Phone Number: 857-364-5309; Email: anica.plesskaiser@va.gov
• Study Contact Backup: Name: Andrea Carney; Phone Number: 857-364-4143; Email: andrea.carney@va.gov

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Recruiting
      • VA Boston Healthcare System
      • Contact: Anica Pless Kaiser, PhD; Phone Number: 857-364-5309; Email: anica.plesskaiser@va.gov
      • Contact: Andrea Carney; Phone Number: 857-364-4143; Email: andrea.carney@va.gov
      • Principal Investigator: Anica Pless Kaiser, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Tai Chi; See above description
ACTIVE_COMPARATOR: 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.	Behavioral: Wellness Education; See above description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Physical Activity Questionnaire	Physical activity	at pre-intervention and at post-intervention, about 12 weeks

Collaborators and Investigators

• Sponsor: VA Boston Healthcare System
• Collaborators: Boston University; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Anica Pless Kaiser, PhD, VA Boston Healthcare System and Boston University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2019
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (ACTUAL): August 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: PTSD; Physical activity; Tai Chi; Older Veterans
• Other Study ID Numbers: P30AG048785 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No