Novel Interventions for Gulf War Veterans' Illnesses

针对海湾战争退伍军人疾病的新颖干预措施

• 批准号: 9892961
• 负责人: Deanna L. Mori
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9892961
• 关键词: Adverse drug effect; Aftercare; Chinese People; Chronic; Cognition; Diffusion Magnetic Resonance Imaging; Education; Effectiveness; Exercise; Fatigue; Functional Magnetic Resonance Imaging; Goals; Gulf War; Healthcare; Home environment; Individual; Intervention; Investigation; Length; MRI Scans; Measures; Mind-Body Intervention; Participant; Patients; Pharmacotherapy; Physical Function; Pilot Projects; Quality of life; Randomized; Reporting; Research; Research Design; Rest; Stretching; Symptoms; Tai Ji; Treatment Efficacy; Veterans; Well in self; Work; chronic pain; cognitive function; comparison intervention; disabling symptom; effective therapy; experience; follow up assessment; follow-up; improved; intervention participants; meetings; neurobiological mechanism; novel; pain reduction; pain symptom; persistent symptom; physical conditioning; public health relevance; randomized trial; reduce symptoms; symptom treatment

 DESCRIPTION (provided by applicant): 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. Our long-term goal is 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, we have demonstrated that Tai Chi can improve both physical health and psychological well-being in patients with a variety of chronic conditions. The proposed randomized trial will establish the effectiveness of a Tai Chi mind-body treatment in Veterans with GWVI. One hundred and twenty participants meeting criteria for GWVI will be randomly assigned to either a Tai Chi exercise or a stretching and wellness education group for 12 weeks with a post-treatment assessment, and follow-up assessments. For an exploratory sub-study, 40 Veterans (approximately 20 from each condition) will undergo MRI scanning at each assessment point. We will accomplish 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. We hypothesize 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. We hypothesize 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. Specific Aim 3: Explore a potential neurobiological mechanism by which Tai Chi can reduce pain and other symptoms and improve quality of life in Veterans with GWVI. We hypothesize differences in resting state fMRI and on diffusion tensor imaging (DTI) in participants randomized to the Tai Chi intervention compared with Wellness intervention participants and that these differences will maintain over the 9-month follow-up period. The proposed trial, informed by our prior investigations, with a robust study design and strong research team, will produce valuable results that can have a direct and immediate impact on healthcare practices for GWVI. If proven as an effective treatment for the symptoms of GWVI, this non-pharmaceutical treatment could easily be implemented in VA facilities, and Veterans could be taught how to continue to practice independently within their own homes. Providing GW Veterans even moderate relief from chronic and debilitating symptoms of GWVI could have a profound impact on improving their overall sense of well-being and quality of life, the ultimate measure of treatment efficacy.

 描述（由申请人提供）： 超过40，000名在1991年海湾战争（GW）中服役的退伍军人患有慢性多症状疾病，定义了海湾战争退伍军人疾病（GWVI）。由于没有现有的经证实的治疗方法来缓解这些患者，因此找到有效和可接受的GWVI治疗方法至关重要。 我们的长期目标是开发一种安全，易于获得的身心治疗方法，以减少疼痛和其他慢性症状，并提高GWVI退伍军人的健康。太极是一种传统的中国身心疗法，已经实行了几个世纪。在过去的十年中，我们已经证明太极拳可以改善各种慢性病患者的身体健康和心理健康。 拟议的随机试验将建立太极身心治疗退伍军人GWVI的有效性。120名符合GWVI标准的参与者将被随机分配到太极锻炼组或拉伸和健康教育组，为期12周，并进行治疗后评估和随访评估。对于探索性子研究，40名退伍军人（每种疾病约20名）将在每个评估点接受MRI扫描。我们将实现以下具体目标：具体目标1：评估太极干预是否会减少GWVI退伍军人的疼痛症状超过健康干预。我们假设，随机分配到太极干预的参与者将显示出比健康干预更大的疼痛症状减轻，并将在9个月的随访期内保持变化。 具体目标二：评估太极拳干预是否改善了GWVI退伍军人的疲劳，认知，生活质量和身体功能，与健康干预相比。我们假设，被随机分配到太极干预的参与者将比那些在疲劳，认知功能，生活质量和身体功能方面有更多的改善。 随机分配到健康干预，并将在9个月的随访期内保持变化。 具体目标3：探索一种潜在的神经生物学机制，通过这种机制，太极拳可以减轻疼痛和其他症状，改善GWVI退伍军人的生活质量。我们假设，与健康干预参与者相比，随机接受太极干预的参与者在静息状态fMRI和弥散张量成像（DTI）方面存在差异，并且这些差异将在9个月的随访期间保持不变。 拟议的试验，根据我们先前的调查，具有强大的研究设计和强大的研究团队，将产生有价值的结果，可以对GWVI的医疗保健实践产生直接和立即的影响。如果被证明是一种有效的治疗GWVI症状的方法，这种非药物治疗可以很容易地在VA设施中实施，退伍军人可以被教导如何继续在自己的家中独立实践。为GW退伍军人提供GWVI慢性和衰弱症状的中度缓解可能对改善他们的整体幸福感和生活质量产生深远的影响，这是治疗效果的最终衡量标准。