N/A
N=114
Novel Interventions for GWVI
Gulf War Veteran's Illness
Bottom Line
View on ClinicalTrials.gov: NCT02661997 ↗Enrolled (actual)
114
Serious AEs
1.8%
Results posted
Nov 2024
Primary outcome: Primary: Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference — 4.47; 4.77; 3.59; 3.66 score on a scale — p=0.58
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tai Chi Intervention (Behavioral); Wellness Intervention (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference |
4.47; 4.77; 3.59; 3.66 | 0.58 |
| PRIMARY Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity |
4.28; 4.75; 4.02; 4.43 | 0.88 |
| SECONDARY Change in Multi-dimensional Fatigue Inventory (MFI-20) |
3.62; 3.72; 3.55; 3.42 | 0.17 |
| SECONDARY PROMIS Global Health Scale - Physical Health Subscale |
2.88; 2.93; 3.00; 3.02 | 0.88 |
| SECONDARY 50 Foot Walk Test |
10.72; 10.55; 11.27; 9.64 | 0.032 sig |
| SECONDARY Change in Trail Making Test (TMT) - Trails A |
25.28; 27.96; 24.75; 26.29 | 0.44 |
| SECONDARY Change in Trail Making Test (TMT) - Trails B |
65.91; 63.52; 66.04; 60.52 | 0.73 |
| SECONDARY Change in Hopkins Verbal Learning Test - Revised (HVLT-R) |
22.25; 21.27; 23.85; 22.59 | 0.36 |
| SECONDARY PROMIS Global Health Scale - Mental Health Subscale |
2.44; 2.67; 2.73; 2.83 | 0.24 |
| SECONDARY Short Physical Performance Battery (SPPB) - 4-Meter Walk Test |
5.26; 5.54; 5.23; 4.70 | 0.006 sig |
| SECONDARY Short Physical Performance Battery (SPPB) - Chair Stand Test (CST) |
13.60; 12.49; 13.92; 13.20 | 0.55 |
| SECONDARY Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT) |
1.0; 1.0; 1.0; .95 | 0.36 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Served in the 1991 Gulf War.
- Meets criteria for chronic multisymptom illness (CMI) based on CDC criteria32 characterized by one or more symptoms of at least 6 months duration from at least two of three symptom categories: 1) musculoskeletal pain (muscle pain, joint pain, or stiffness); 2) fatigue; and 3) mood-cognition.
- One symptom of CMI must be musculoskeletal or joint pain or stiffness of at least 6 months duration (in addition to fatigue or cognitive complaints of the CDC criteria32).
- Not planning to relocate in next 3 months
- English-Speaking: English is the only language to be used during the exercise training program. Our self-reported outcome measures are obtained from validated English-version questionnaires. In addition, using other languages would likely require separate classes, recruitment and instructors which are beyond our current study scope.
- Has access to a home computer or device that will allow telehealth delivery of the intervention.
Exclusion Criteria
- Lacks the capacity to provide consent
- Major medical, psychiatric, or neurological disorder or has a moderate or severe traumatic brain injury, which could interfere with their ability to safely engage in Tai Chi exercises.
- Change in psychotropic or pain medication during the past month
- This will minimize amount of symptom change due to medication alterations
- Once enrolled, medication changes are nonetheless expected and will be monitored
- Regular current Tai Chi, mindfulness, or yoga practice, defined as at least three hours per week for more than three months.
- Veterans with prior experience who do not currently engage in regular practice at this level will be eligible
- Reports difficulty standing on feet for the majority of a Tai Chi class (approximately 60 minutes).
- Participants who are disruptive or disrespectful or engage in behavior that threatens staff and/or participant safety may be terminated from the study.
- Participants who are currently involved in another treatment study that might confound our findings (e.g., treatments for GWI, pain).
Data sourced from ClinicalTrials.gov (NCT02661997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.