Tai Chi + Wellness for Gulf War Syndrome

(NIGWVI Trial)

Overseen By Deanna L Mori, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Psychotropic, Pain medications

Disqualifiers: Major medical, Psychiatric, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 12 weeks

114 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that changes in psychotropic or pain medication in the past month are not allowed. Once enrolled, medication changes are expected and will be monitored.

What data supports the effectiveness of the treatment Tai Chi and Wellness Intervention for Gulf War Syndrome?

Research suggests that Tai Chi, a mind-body exercise, may help alleviate symptoms of Gulf War Illness, such as fatigue, pain, and sleep problems, although more studies are needed to confirm its effectiveness. Additionally, similar integrative health approaches like yoga have shown benefits for chronic pain in veterans with Gulf War Illness. ^{1 2 3 4 5}

Is Tai Chi safe for humans?

Tai Chi is generally considered safe for humans, with very few reports of adverse events (unwanted side effects) in studies. However, adverse events were underreported in some research, so it's important to consult with a healthcare provider before starting any new exercise program. ^{1 2 6 7 8}

How does the Tai Chi and Wellness treatment differ from other treatments for Gulf War Syndrome?

The Tai Chi and Wellness treatment is unique because it combines a mind-body exercise approach with wellness practices, which may help alleviate symptoms of Gulf War Syndrome like fatigue, pain, and cognitive issues. Unlike other treatments, it focuses on enhancing both physical and mental health without relying on medication, and there are currently no standard treatments for this condition. ^{1 2 3 9 10}

What is the purpose of this trial?

The primary aim of this study was to examine the beneficial effects of two novel treatments for Gulf War Veteran's Illness (Tai Chi and Wellness intervention) and to establish the efficacy of these mind-body approaches to symptom reduction. In March 2020 after 53 Veterans were randomized, this trial was halted due to the onset of COVID-19. In late 2020, we shifted from conducting an in-person study to a fully remote study with interventions delivered via synchronous video teleconferencing. We then randomized an additional 61 Veterans for a study grand total of 114 Veterans.

Research Team

DeAnna L Mori, PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Barbara L. Niles, PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Eligibility Criteria

This trial is for Gulf War veterans who have been experiencing musculoskeletal or joint pain, fatigue, and mood-cognition issues for at least six months. Participants must have served in the 1991 Gulf War, meet CDC criteria for chronic multisymptom illness (CMI), speak English, not plan to move within three months, and be able to access a computer for telehealth sessions.

Inclusion Criteria

I have long-term symptoms in at least two of these areas: muscle or joint pain, fatigue, mood or thinking problems.

Not planning to relocate in next 3 months

I have had muscle or joint pain or stiffness for at least 6 months.

Exclusion Criteria

Participants who are disruptive or disrespectful or engage in behavior that threatens staff and/or participant safety may be terminated from the study

I do not have any major health or brain issues that would stop me from safely doing Tai Chi.

I haven't changed my mental health or pain medication in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Tai Chi or Wellness intervention for 12 weeks, with sessions twice a week

12 weeks

24 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 9 months post-intervention

9 months

2 assessments (virtual)

Treatment Details

Interventions

• Tai Chi Intervention
• Wellness Intervention

Trial Overview The study is testing the effectiveness of Tai Chi and Wellness interventions as treatments for symptoms of Gulf War Veteran's Illness. It aims to determine if these mind-body approaches can reduce symptom severity compared to usual care practices.

Participant Groups

Group I: Tai Chi Intervention Experimental Treatment 1 Intervention

All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.

Group II: Wellness Intervention Active Control 1 Intervention

The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Tufts Medical Center

Collaborator

Trials

264

Recruited

264,000+

Findings from Research

Tai chi (TC) is generally safe, with no serious adverse events reported in a review of 153 randomized controlled trials, primarily involving older adults, although minor musculoskeletal issues like knee and back pain were noted.

Only 33% of the trials reported adverse events, and just 12% had a clear protocol for monitoring them, indicating that the inconsistent reporting limits our understanding of TC's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. Wayne, PM., Berkowitz, DL., Litrownik, DE., et al.[2022]

A significant increase in clinical studies on Tai Chi was observed from 2010 to 2020, with 987 studies identified, primarily randomized controlled trials, indicating growing interest in its health benefits, especially for older adults and conditions like hypertension and depression.

Most studies showed positive outcomes for Tai Chi, with 93.8% reporting at least one favorable result, although adverse events were underreported, highlighting the need for better reporting standards in Tai Chi research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tai Chi for health and well-being: A bibliometric analysis of published clinical studies between 2010 and 2020. Yang, GY., Sabag, A., Hao, WL., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The Effects of Tai Chi Mind-Body Approach on the Mechanisms of Gulf War Illness: an Umbrella Review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Study protocol for a revised randomized trial: Remotely delivered Tai Chi and wellness for Gulf War illness. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Yoga is effective for treating chronic pain in veterans with Gulf War Illness at long-term follow-up. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy and exercise minimally help Gulf War veterans' illnesses. [2003]

5. United States pubmed.ncbi.nlm.nih.gov

A multicenter two by two factorial trial of cognitive behavioral therapy and aerobic exercise for Gulf War veterans' illnesses: design of a veterans affairs cooperative study (CSP #470). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. [2022]

7. Scotland pubmed.ncbi.nlm.nih.gov

Tai Chi for health and well-being: A bibliometric analysis of published clinical studies between 2010 and 2020. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Complementary/integrative healthcare utilization in US Gulf-War era veterans: Descriptive analyses based on deployment history, combat exposure, and Gulf War Illness. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Gulf War Illness: A Randomized Controlled Trial Combining Mindfulness Meditation and Auricular Acupuncture. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Physical health, mental health, and utilization of complementary and alternative medicine services among Gulf War veterans. [2018]