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Tai Chi and Wellness Education for Older Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624868
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : May 20, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Boston University
Information provided by (Responsible Party):
Anica Pless Kaiser, VA Boston Healthcare System

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.

Condition or disease Intervention/treatment Phase
Physical Activity PTSD Satisfaction Behavioral: Tai Chi Behavioral: Wellness Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to Tai Chi or Wellness Education
Masking: Single (Outcomes Assessor)
Masking Description: Pre- and Post-intervention assessments will be conducted by an assessor who is blind to study condition.
Primary Purpose: Treatment
Official Title: A Randomized Pilot Trial of Tai Chi Compared to Wellness Education for Older Veterans
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Senior Fitness Test [ Time Frame: at pre-intervention and at post-intervention, about 12 weeks ]
    Physical fitness

  2. Posttraumatic Stress Disorder Checklist (PCL-5) [ Time Frame: at pre-intervention and at post-intervention, about 12 weeks ]
    PTSD checklist


Secondary Outcome Measures :
  1. International Physical Activity Questionnaire [ Time Frame: at pre-intervention and at post-intervention, about 12 weeks ]
    Physical activity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624868


Contacts
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Contact: Anica Pless Kaiser, PhD 857-364-5309 Anica.PlessKaiser@va.gov
Contact: Andrea Carney 857-364-4143 Andrea.Carney@va.gov

Locations
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United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Anica Pless Kaiser, PhD    857-364-5309    anica.plesskaiser@va.gov   
Contact: Andrea Carney    857-364-4143    andrea.carney@va.gov   
Principal Investigator: Anica Pless Kaiser, PhD         
Sponsors and Collaborators
VA Boston Healthcare System
National Institute on Aging (NIA)
Boston University
Investigators
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Principal Investigator: Anica Pless Kaiser, PhD VA Boston Healthcare System and Boston University School of Medicine
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Responsible Party: Anica Pless Kaiser, Clinical Research Psychologist, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT03624868    
Other Study ID Numbers: P30AG048785 ( U.S. NIH Grant/Contract )
P30AG048785 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anica Pless Kaiser, VA Boston Healthcare System:
Tai Chi
Older Veterans
Physical activity
PTSD