Gulf War Veteran's IllnessNIGWVINCT02661997
Novel Interventions for GWVI
A study testing Tai Chi Intervention and Wellness Intervention in people with Gulf War Veteran's Illness, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gulf War Veteran's Illness
- What is being tested?
- Tai Chi Intervention and Wellness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
Official title: Novel Interventions for Gulf War Veterans' Illnesses
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.
Read the detailed description
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.
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
- Gulf War Veteran's Illness
- Being tested
- Tai Chi Intervention, Wellness Intervention
- Keywords
- Tai Chi, Wellness, Mind-body, Gulf War Illness, Gulf War Veteran's Illness, GWVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Intervention | Experimental | 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. Receives: Behavioral: Tai Chi Intervention |
| Wellness Intervention | Active comparator | 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. Receives: Behavioral: Wellness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference
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.
Measured: Change from baseline to post-treatment at 12 weeks
Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity
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.
Measured: Change from baseline to post-treatment at 12 weeks
Secondary outcomes (10)
Change in Multi-dimensional Fatigue Inventory (MFI-20)
The Multidimensional Fatigue Inventory (MFI-20) is a widely-used self-report measure that quantifies symptoms of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Internal consistency and test-retest reliability are strong for all subscales. Responses are made on a 5-point scale from 1-5, with higher scores reflecting greater fatigue. 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 1 and a maximum score of 5. Results from the General Fatigue Subscale are provided below.
Measured: Change from baseline to post-treatment at 12 weeks
PROMIS Global Health Scale - Physical Health Subscale
The PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities, and two scores are produced: Physical Health and Mental Health. Results from the Physical Health Subscale are presented below. 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 1 and a maximum score of 5. Higher scores reflect a better outcome.
Measured: Change from baseline to post-treatment at 12 weeks
50 Foot Walk Test
The Walk 50FT is a widely used timed measure of fast walking speed. It involves a participant walking 50 feet without any use of an aid while study staff monitor and record their time in seconds using a stopwatch. Participants are instructed to walk "as fast as possible." Two trials of the Walk 50FT were conducted and an average score of these two trials was produced. A lower Walk 50FT score is indicative of higher (i.e., faster) walking speed. The Walk 50FT is empirically supported, possesses strong validity and reliability, and demonstrates sensitivity to change over time among individuals with chronic disorders and is a promising measure of physical functioning in patients with a pain-related condition.
Measured: Change from baseline to post-treatment (12 weeks)
Change in Trail Making Test (TMT) - Trails A
The Trail Making Test (TMT) is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task with higher scores reflecting a worse outcome. Results from Trails A are presented below.
Measured: Change from baseline to post-treatment at 12 weeks
Change in Trail Making Test (TMT) - Trails B
The Trail Making Test (TMT) is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Trails A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Trails B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task with higher scores reflecting a worse outcome. Results from Trails B is reported below.
Measured: Change from baseline to post-treatment at 12 weeks
Change in Hopkins Verbal Learning Test - Revised (HVLT-R)
The Hopkins Verbal Learning Test- Revised (HVLT-R) is a cognitive test of verbal learning and memory task where participants are instructed to learn a list of 12 nouns over three learning trials. Each time study staff read the list of words, participants are asked to recall as many words from the list as they can remember immediately afterwards. The sum of correctly recalled words over the three trials is a measure of total recall. Scores can range from 0 to 36 with higher scores reflect better a better outcome.
Measured: Change from baseline to post-treatment at 12 weeks
PROMIS Global Health Scale - Mental Health Subscale
The PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities, and two scores are produced: Physical Health and Mental Health. Results from the Mental Health Subscale are presented below. 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 1 and a maximum score of 5. Higher scores reflect a better outcome.
Measured: Change from baseline to post-treatment at 12 weeks
Short Physical Performance Battery (SPPB) - 4-Meter Walk Test
The Short Physical Performance Battery (SPPB) captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB is based on three timed measures of standing balance, walking (gait) speed, and ability to rise from a chair. The 4-Meter Walk Test is a measure of gate speed where participants are asked to walk 4-meters at a normal walking pace while being timed. Results from the 4-Meter Walk Test are presented below.
Measured: Change from baseline to post-treatment at 12 weeks
Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)
The Short Physical Performance Battery (SPPB) captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB consists of three timed measures: standing balance, walking speed, and ability to rise from a chair. The Chair Sit Test (CST) is a timed evaluation of the strength and power of lower-extremities. Participants are instructed to complete five chair stands from a sitting position with their arms folded across their chests. They are instructed to do this as fast as possible, while being timed. Lower scores reflect a better outcome.
Measured: Change from baseline to post-treatment at 12 weeks
Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)
The SPPB captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB consists of three timed measures: standing balance, walking speed, and ability to rise from a chair. The Standing Balance Test measures ability to balance while holding in three different positions for 10 seconds. For each position they are able to hold for 10 seconds, they receive a score of 1. If they are unable to hold the position, they receive a score of 0. To illustrate the minimal variability on this measure, results are provided below for the tandem position (the most difficult position to hold).
Measured: Change from baseline to post-treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start1 Jun 2017
- Primary completion29 Sep 2023
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gulf War Veteran's IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Boston University, Tufts Medical Center
- Responsible party
- Sponsor
- Investigators
- Barbara L. Niles, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MADeAnna L Mori, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661997
- Sponsor's protocol ID
- SPLD-004-15S
- Acronym
- NIGWVI
- Status last verified
- Oct 2025
- First submitted
- 14 Jan 2016
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36494045
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Interventions for Gulf War Veterans' Illnesses
- ClinicalTrials.gov ID
- NCT02661997
- Acronym / sponsor ID
- NIGWVI / SPLD-004-15S
- Conditions
- Gulf War Veteran's Illness
- Keywords
- Tai Chi, Wellness, Mind-body, Gulf War Illness, Gulf War Veteran's Illness, GWVI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Boston University, Tufts Medical Center
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Intervention | Experimental | Behavioral: Tai Chi InterventionAll 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 | Active comparator | Behavioral: Wellness InterventionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
- Regular current Tai Chi, mindfulness, or yoga practice, defined as at least three hours per week for more than three months.
- Reports difficulty standing on feet for the majority of a Tai Chi class (approximately 60 minutes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi InterventionAll 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. | Behavioural | Tai Chi Intervention |
| Wellness InterventionThe 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. | Behavioural | Wellness Intervention |
Primary outcome
Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference
Time frame: 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
Time frame: 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.
10 secondary outcomes
Change in Multi-dimensional Fatigue Inventory (MFI-20)
Time frame: Change from baseline to post-treatment at 12 weeks
PROMIS Global Health Scale - Physical Health Subscale
Time frame: Change from baseline to post-treatment at 12 weeks
50 Foot Walk Test
Time frame: Change from baseline to post-treatment (12 weeks)
Change in Trail Making Test (TMT) - Trails A
Time frame: Change from baseline to post-treatment at 12 weeks
Change in Trail Making Test (TMT) - Trails B
Time frame: Change from baseline to post-treatment at 12 weeks
Change in Hopkins Verbal Learning Test - Revised (HVLT-R)
Time frame: Change from baseline to post-treatment at 12 weeks
PROMIS Global Health Scale - Mental Health Subscale
Time frame: Change from baseline to post-treatment at 12 weeks
Short Physical Performance Battery (SPPB) - 4-Meter Walk Test
Time frame: Change from baseline to post-treatment at 12 weeks
Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)
Time frame: Change from baseline to post-treatment at 12 weeks
Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)
Time frame: Change from baseline to post-treatment at 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36494045Niles 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.
- IRB approved webpage - Novel Interventions for Gulf War Illness studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara L. Niles, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
DeAnna L Mori, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Intervention and Wellness Intervention in people with Gulf War Veteran's Illness, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference (time frame: Change from baseline to post-treatment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.