Physical ActivityNCT03624868
Tai Chi and Wellness Education for Older Veterans
A study testing Tai Chi and Wellness Education in people with Physical Activity and PTSD, run by VA Boston Healthcare System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, PTSD, Satisfaction
- What is being tested?
- Tai Chi and Wellness Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 20 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02130
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity, PTSD, Satisfaction
- Being tested
- Tai Chi, Wellness Education
- Keywords
- Tai Chi, Older Veterans, Physical activity, PTSD
- Medical subject headings
- Motor Activity, Stress Disorders, Post-Traumatic, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
See above description
Wellness EducationBehavioural
See above description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Wellness Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Senior Fitness Test
Physical fitness
Measured: at pre-intervention and at post-intervention, about 12 weeks
Posttraumatic Stress Disorder Checklist (PCL-5)
PTSD checklist
Measured: at pre-intervention and at post-intervention, about 12 weeks
Secondary outcomes (1)
International Physical Activity Questionnaire
Physical activity
Measured: at pre-intervention and at post-intervention, about 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start29 Jan 2019
- Primary completion29 Jan 2022
- Study completion20 Apr 2022
Why it stopped: The study was stopped after completing 2 cohorts instead of the intended 3 cohorts. This was due to logistical issues and budget-related issues (timing of being able to spend the funds).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to Tai Chi or Wellness Education
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- National Institute on Aging (NIA), Boston University
- Responsible party
- Principal investigator, Anica Pless Kaiser, VA Boston Healthcare System
- Investigators
- Anica Pless Kaiser, PhD, Principal investigator, VA Boston Healthcare System and Boston University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624868
- Sponsor's protocol ID
- P30AG048785
- Other IDs
- P30AG048785
- Status last verified
- Mar 2025
- First submitted
- 3 Aug 2018
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Trial of Tai Chi Compared to Wellness Education for Older Veterans
- ClinicalTrials.gov ID
- NCT03624868
- Acronym / sponsor ID
- P30AG048785
- Conditions
- Physical Activity, PTSD, Satisfaction
- Keywords
- Tai Chi, Older Veterans, Physical activity, PTSD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped after completing 2 cohorts instead of the intended 3 cohorts. This was due to logistical issues and budget-related issues (timing of being able to spend the funds).
- Enrolment
- 24 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Collaborators
- National Institute on Aging (NIA), Boston University
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to Tai Chi or Wellness Education
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiA 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. |
| Wellness Education | Active comparator | Behavioral: Wellness EducationThe 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiSee above description | Behavioural | Tai Chi |
| Wellness EducationSee above description | Behavioural | Wellness Education |
Primary outcome
Senior Fitness Test
Time frame: at pre-intervention and at post-intervention, about 12 weeks
Physical fitness
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: at pre-intervention and at post-intervention, about 12 weeks
PTSD checklist
1 secondary outcome
International Physical Activity Questionnaire
Time frame: at pre-intervention and at post-intervention, about 12 weeks
Results and safety
The study was stopped early (reason given: The study was stopped after completing 2 cohorts instead of the intended 3 cohorts. This was due to logistical issues and budget-related issues (timing of being able to spend the funds).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anica Pless Kaiser, PhD principal investigator
VA Boston Healthcare System and Boston University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Wellness Education in people with Physical Activity and PTSD, run by VA Boston Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped after completing 2 cohorts instead of the intended 3 cohorts. This was due to logistical issues and budget-related issues (timing of being able to spend the funds).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Senior Fitness Test (time frame: at pre-intervention and at post-intervention, about 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.