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Mind-Body Intervention
Tai Chi + Wellness for Gulf War Syndrome (NIGWVI Trial)
N/A
Waitlist Available
Led By Barbara L. Niles, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 criteria)
Meets criteria for chronic multisymptom illness (CMI) based on CDC criteria 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline 50 foot walk test at 12 weeks
Awards & highlights
NIGWVI Trial Summary
This trial is testing if Tai Chi and Wellness interventions can help reduce symptoms in Gulf War Veterans.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since Tai Chi and Wellness are non-invasive mind-body interventions focusing on movement and mental health exercises, side effects may include muscle soreness or strain from physical activity. However, they are generally considered low-risk activities.
NIGWVI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had muscle or joint pain or stiffness for at least 6 months.
Select...
I have long-term symptoms in at least two of these areas: muscle or joint pain, fatigue, mood or thinking problems.
NIGWVI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline mfi-20 at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline mfi-20 at 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brief Pain Inventory - Short Form (BPI)
Secondary outcome measures
50 Foot Walk Test
Change in Hopkins Verbal Learning Test - Revised (HVLT-R)
Change in Multi-dimensional Fatigue Inventory (MFI-20)
+3 moreOther outcome measures
Blood Pressure
Body Mass Index
Change in Chronic Pain Self-Efficacy Scale (CPSS)
+16 moreNIGWVI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tai Chi InterventionExperimental Treatment1 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 InterventionActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tai Chi Intervention
2014
N/A
~390
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,345 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
128 Patients Enrolled for Gulf War Syndrome
Boston UniversityOTHER
454 Previous Clinical Trials
9,941,449 Total Patients Enrolled
3 Trials studying Gulf War Syndrome
430 Patients Enrolled for Gulf War Syndrome
Tufts Medical CenterOTHER
254 Previous Clinical Trials
255,027 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have long-term symptoms in at least two of these areas: muscle or joint pain, fatigue, mood or thinking problems.I have had muscle or joint pain or stiffness for at least 6 months.I am fluent in English and can participate in English-only programs.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.I struggle to stand for most of a 60-minute Tai Chi class.You regularly practice Tai Chi, mindfulness, or yoga for at least three hours per week for more than three months. If you used to practice regularly but don't anymore, you can still participate.I am unable to understand or sign a consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Tai Chi Intervention
- Group 2: Wellness Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being recruited for this clinical trial?
"As indicated on clinicaltrials.gov, this medical trial is not currently seeking patients for enrollment. The initial posting was made June 1st 2017 and the most recent edit occurred August 2nd 2022. However, there are other trials actively enrolling participants at this juncture."
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