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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Tai Chi and a wellness program can reduce symptoms for veterans with Gulf War Syndrome. Gulf War Syndrome includes persistent issues like muscle pain, fatigue, and mood or cognitive problems. The trial involves two groups: one practices Tai Chi, a form of moderate exercise and meditation, while the other participates in a wellness program covering various health aspects. Veterans who served in the 1991 Gulf War and have experienced symptoms like muscle pain or fatigue for over six months may be eligible. Participants need computer access for remote sessions.

As an unphased trial, this study offers veterans a unique opportunity to explore alternative therapies that may enhance their quality of life.

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 prior data suggests that these interventions are safe for Gulf War Veterans?

Research shows that Tai Chi is a safe treatment option. This traditional Chinese exercise combines gentle movements and meditation. Most studies have shown positive results with few side effects, indicating it is well-tolerated.

Similar programs for the Wellness Intervention have succeeded in other studies, with participants usually reporting few side effects. The program emphasizes overall wellness, including physical, emotional, and spiritual health.

These findings suggest that both Tai Chi and the Wellness Intervention are generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Gulf War Syndrome because they offer a holistic approach that differs from typical pharmaceutical options like pain relievers or antidepressants. The Tai Chi Intervention is unique because it incorporates physical movement, meditation, and breathing exercises, promoting both physical and mental well-being. The Wellness Intervention complements this by focusing on overall health through the VA Whole Health Program, which addresses physical, emotional, and spiritual wellness. Together, these treatments aim to improve quality of life without relying on medication, which is a fresh perspective in managing Gulf War Syndrome.

What evidence suggests that this trial's treatments could be effective for Gulf War Syndrome?

Research has shown that Tai Chi might help improve symptoms of Gulf War Illness, such as tiredness, pain, and sleep issues. In this trial, some participants will practice Tai Chi, which involves gentle movements, breathing exercises, and meditation to reduce stress and enhance overall well-being. Veterans who practiced Tai Chi reported feeling better in these areas compared to those in a general wellness program. Meanwhile, other participants will engage in the wellness program, which also focuses on improving health and has proven successful in other studies. Both Tai Chi and the wellness program aim to boost physical, emotional, and spiritual health, offering promising options for symptom relief. ^{1 2 3 6 7}

Who Is on the Research Team?

Barbara L. Niles, PhD

Principal Investigator

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

DeAnna L Mori, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 am fluent in English and can participate in English-only programs.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40470637/

Physical Activity and Functioning Following Tai Chi and a ... The present study is a secondary analysis of data from a randomized controlled trial comparing Tai Chi to a Wellness intervention on physical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9918688/

Remotely Delivered Tai Chi and Wellness for Gulf War Illness The primary aim is to examine if Tai Chi is associated with greater improvements in GWI symptoms in Veterans with GWI compared to a Wellness intervention.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003718

Remotely delivered Tai Chi and wellness for Gulf War illness The primary aim is to examine if Tai Chi is associated with greater improvements in GWI symptoms in Veterans with GWI compared to a Wellness intervention.

4. withpower.com withpower.com/trial/tai-chi-wellness-for-gulf-war-syndrome-ed362

Tai Chi + Wellness for Gulf War Syndrome (NIGWVI Trial) 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213422019300964

The effects of tai chi mind-body approach on ... Tai Chi showed improvements in chronic pain for patients with OA, LBP, and osteoporosis. Raman and colleagues conducted the first systematic review and meta- ...

6. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/gulf-war-illness-REPORT.pdf

Gulf War Illness: A Systematic Review of Therapeutic ... Preliminary results (N=17) from 1 crossover RCT of a low-glutamate diet found significant improvement in PTSD and anxiety (see Appendix D, Table.

7. cdmrp.health.mil cdmrp.health.mil/gwirp/pdfs/GWIRP_Landscape_2020.pdf

GWIRP Landscape Tai chi is a traditional Chinese mind-body therapy that can ... perpetuation of complex chronic illness: Gulf War illness and chronic fatigue syndrome.