Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2017-06-01
2025-09-30
Brief Summary
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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.
Detailed Description
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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.
Research Design: One hundred and fourteen GW Veterans meeting criteria for GWVI were randomly assigned to either the Tai Chi Condition (n=58) or the Wellness Condition (n=56).
Methodology: Participants received 12 weeks of the randomly-assigned intervention twice each week. Assessments were conducted at baseline, 12 weeks (post-intervention), 24 weeks (3 months post-intervention) and 48 weeks (9 months post-intervention). Assessments included instruments to measure self-reported pain, fatigue, cognition, quality of life, and physical functioning.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tai Chi 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.
Tai Chi 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.
Wellness 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.
Wellness 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.
Interventions
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Tai Chi 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.
Wellness 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
ALL
No
Sponsors
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Boston University
OTHER
Tufts Medical Center
OTHER
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Barbara L. Niles, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
DeAnna L Mori, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Locations
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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
Countries
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References
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Niles BL, Grossman S, McQuade M, Grossman D, Kaiser AP, Muccio B, Warner B, Wang C, Mori DL. Study protocol for a revised randomized trial: Remotely delivered Tai Chi and wellness for Gulf War illness. Contemp Clin Trials. 2023 Feb;125:107045. doi: 10.1016/j.cct.2022.107045. Epub 2022 Dec 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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IRB approved webpage - Novel Interventions for Gulf War Illness study
Other Identifiers
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SPLD-004-15S
Identifier Type: -
Identifier Source: org_study_id