Novel Interventions for Gulf War Veterans' Illnesses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference
研究概览
简要总结
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.
详细描述
Objectives: Over 40,000 Veterans who served in the 1991 Gulf War (GW) have a persistent form of chronic multisymptom illness that defines Gulf War Veterans Illness (GWVI). With no existing proven treatments to provide relief to these sufferers, it is critical to find efficacious and acceptable treatments for GWVI.
The long-term goal was to develop a safe, readily available, mind-body treatment to reduce pain and other chronic symptoms and enhance wellness in Veterans with GWVI. Tai Chi is a traditional Chinese mind-body therapy that has been practiced for centuries. In the last decade, the investigators have demonstrated that Tai Chi can improve both physical health and psychological wellbeing in patients with a variety of chronic conditions.
This randomized trial aimed to establish the effectiveness of a Tai Chi mind-body treatment in Veterans with GWVI. One hundred and fourteen participants meeting criteria for GWVI were randomly assigned to either a Tai Chi exercise or a wellness education group for 12 weeks with a post treatment assessment, and follow-up assessments. The investigators addressed the following Specific Aims:
Specific Aim 1: Evaluate whether the Tai Chi intervention will reduce symptoms of pain in Veterans with GWVI more than the Wellness intervention. The investigators hypothesized that participants randomized to the Tai Chi intervention will show a greater reduction in pain symptoms than those in the Wellness intervention and will maintain changes over a 9-month follow-up period.
Specific Aim 2: Evaluate whether the Tai Chi intervention improves fatigue, cognition, quality of life, and physical functioning in GW Veterans with GWVI, as compared to the Wellness intervention. The investigators hypothesized that participants randomized to the Tai Chi intervention will evidence more improvement in fatigue, cognitive functioning, quality of life, and physical functioning than those randomized to the Wellness intervention and will maintain changes over a 9-month follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference
时间窗: Change from baseline to post-treatment at 12 weeks
The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Interference subscale are reported below. Each item of the 7-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.
Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity
时间窗: Change from baseline to post-treatment at 12 weeks
The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Severity subscale are reported below. Each item of the 4-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.
Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference
时间窗: Change from baseline to post-treatment at 12 weeks
The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Interference subscale are reported below. Each item of the 7-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.
Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity
时间窗: Change from baseline to post-treatment at 12 weeks
The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Severity subscale are reported below. Each item of the 4-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.
次要结局
- Change in Multi-dimensional Fatigue Inventory (MFI-20)(Change from baseline to post-treatment at 12 weeks)
- PROMIS Global Health Scale - Physical Health Subscale(Change from baseline to post-treatment at 12 weeks)
- 50 Foot Walk Test(Change from baseline to post-treatment (12 weeks))
- Short Physical Performance Battery (SPPB) - 4-Meter Walk Test(Change from baseline to post-treatment at 12 weeks)
- Change in Trail Making Test (TMT) - Trails A(Change from baseline to post-treatment at 12 weeks)
- Change in Hopkins Verbal Learning Test - Revised (HVLT-R)(Change from baseline to post-treatment at 12 weeks)
- PROMIS Global Health Scale - Mental Health Subscale(Change from baseline to post-treatment at 12 weeks)
- Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)(Change from baseline to post-treatment at 12 weeks)
- Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)(Change from baseline to post-treatment at 12 weeks)
- Change in Trail Making Test (TMT) - Trails B(Change from baseline to post-treatment at 12 weeks)
- PROMIS Global Health Scale - Mental Health Subscale(Change from baseline to post-treatment at 12 weeks)
- Change in Multi-dimensional Fatigue Inventory (MFI-20)(Change from baseline to post-treatment at 12 weeks)
- PROMIS Global Health Scale - Physical Health Subscale(Change from baseline to post-treatment at 12 weeks)
- 50 Foot Walk Test(Change from baseline to post-treatment (12 weeks))
- Change in Trail Making Test (TMT) - Trails A(Change from baseline to post-treatment at 12 weeks)
- Change in Trail Making Test (TMT) - Trails B(Change from baseline to post-treatment at 12 weeks)
- Change in Hopkins Verbal Learning Test - Revised (HVLT-R)(Change from baseline to post-treatment at 12 weeks)
- Short Physical Performance Battery (SPPB) - 4-Meter Walk Test(Change from baseline to post-treatment at 12 weeks)
- Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)(Change from baseline to post-treatment at 12 weeks)
- Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)(Change from baseline to post-treatment at 12 weeks)