Novel Interventions for GWVI (NIGWVI)

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.

Study Overview

• Status: Completed
• Conditions: Gulf War Veteran's Illness
• Intervention / Treatment: Behavioral: Tai Chi Intervention; Behavioral: Wellness Intervention

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130-4817
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change from baseline to post-treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Change from baseline to post-treatment (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.	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).	Change from baseline to post-treatment at 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.	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.	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.	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.	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.	Change from baseline to post-treatment at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Symptom Checklist (HSC)	The Health Symptom Checklist consists of 34 frequently reported health and mental health symptoms from nine body systems (cardiac, pulmonary, dermatological, gastrointestinal, genitourinary, musculoskeletal, neurological, neuropsychological and psychological). On a 5 point scale from 0 (no) to 4 (very often), respondents indicate if they have experienced each symptom in the last 30 days, and if yes, how often. A response of 2 (about once per week) or greater is considered an endorsement of the symptom. All symptoms endorsed are added together for a total score. Total scores can range from 0 to 34 with higher scores indicating more symptoms.	Change from baseline HSC at 12 weeks
The PTSD Checklist for DSM-5 (PCL-5)	The PTSD Checklist for DSM-5 (PCL-5) is a self-report measure consisting of 20 items that parallel the DSM-5 posttraumatic stress disorder criteria. Respondents indicate on a 5-point scale (0-4) how much they have been bothered in the last month by particular symptoms that are related to stressful military experiences. 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 4.The DSM-IV version of the PCL has been shown to have excellent reliability and validity.	Change from baseline PCL-5 at 12 weeks
Insomnia Severity Index (ISI)	The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is comprised of seven questions that are responded to on a scale from 0 to 4.. 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 4, with higher scores reflecting greater insomnia symptom severity.	Change from baseline ISI at 12 weeks
Participant Compliance Log - Intervention Sessions Attended	Study staff will monitor number of intervention sessions attended. The maximum total number of sessions is 24 (range 0-24) with higher numbers showing greater number of sessions attended.	12 weeks
Participant Compliance Log - Assessment Sessions Attended	Percentage of participants who completed the post-treatment assessment.	12 weeks
Weekly Practice Log Sheet	This measure will monitor compliance with home Tai Chi practice during the intervention. Average Tai Chi practice minutes per week is reported.	12 weeks
Client Satisfaction Questionnaire	The Client Satisfaction Questionnaire (CSQ) is is an 8-item measure that assesses satisfaction with both the interventions. Each item is responded to on a 4-point scale (1-4) and items are summed for a total score that can range from 8-32 with higher scores reflecting greater satisfaction.	Difference between two intervention groups at post-treatment (12 weeks)
Depression Anxiety Sensitivity Scale (DASS) - Depression Scale	The Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. 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 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.	Change from baseline DASS at 12 weeks
Depression Anxiety Sensitivity Scale (DASS) - Anxiety Scale	The Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. 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 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.	Change from baseline DASS at 12 weeks
Depression Anxiety Sensitivity Scale (DASS) - Stress Scale	The Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. 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 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.	Change from baseline DASS at 12 weeks
Change in the Pain Catastrophizing Scale (PCS)	The PCS is a 13-item self-report scale that assesses the degree to which people engage in three subtypes of pain catastrophizing: rumination, magnification, and helplessness. Each item is responded to on a 5 point scale (0-4). 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 4, with higher scores reflecting greater pain catastrophizing. It is one of the most widely used instruments for measuring catastrophic thinking in relation to pain.	Change from baseline PCS at 12 weeks
Change in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - General Activity Scale	The West Haven-Yale Multidimensional Pain Inventory (WHMPI) is a well-validated measure of the experience of chronic pain and has been shown to be applicable across a variety of clinical pain conditions. The 52-item inventory is divided into three parts: 1) Important dimensions of the chronic pain experience, 2) patient perceptions of how important others respond to their pain, and 3) engagement in everyday activities. Patient's responses to WHYMPI items are made on a 7-point scale (0-6). The focus of the analysis reported before is on the 18 items that constitute Part 3. This General Activity Scale was scored by summing responses and then obtaining an average by dividing by the number of non-missing items. Total average scores range from 0-6 with higher scores reflecting greater engagement in common everyday activities.	Change from baseline WHYMPI at 12 weeks
Change in Chronic Pain Self-Efficacy Scale (CPSS)	The Chronic Pain Self-Efficacy Scale (CPSS) is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. Questions are broken down into three categories: self-efficacy for pain management, self-efficacy for physical function, and self-efficacy for coping with symptoms. Each item in the CPSS is presented as a question (e.g., "How certain are you that you can decrease your pain quite a bit?"). Participants rate each belief on a 10-point Likert scale (range 10-100). A total score is calculated by first summing the item responses across all three categories. 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 10 and a maximum score of 100, with higher scores reflecting greater perceived self-efficacy.	Change from baseline CPSS at 12 weeks
Group Cohesiveness Scale (GSC)	The Group Cohesiveness Scale is a self-report measure that examines group cohesion within a therapeutic environment. Each of the 7 questions are responded to on a 5-point scale (1-5). Scores are obtained by summing the items with higher scores reflecting greater group cohesiveness.	Post-treatment measure taken at 12 weeks
PROMIS Self-Efficacy for Managing Symptoms	The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms is an 8-item self-report measure that examines elements of self-care. Each item is responded to on a 5 point scale ranging from 1-5. Raw scores are calculated by summing responses to all the items (score range 8-40), and then converted to a T-score using a conversion table located in the administration guide provided for the PROMIS instruments. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores reflect greater confidence in one's ability to manage one's symptoms	Change from baseline PROMIS Self-Efficacy at 12 weeks
Mindfulness Attention Awareness Scale (MAAS)	The Mindfulness Attention Awareness Scale (MAAS) is a 15-item self-report measure that assesses participants' openness towards, awareness of, and attention to the present. This scale can reveal information about one's self-regulation and well-being. Each item is responded to on a 6-point scale from 1 (almost always) to 6 (almost never) with higher scores reflecting greater mindfulness awareness. 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 6.	Change from baseline MAAS at 12 weeks
Body Mass Index (BMI)	Study staff recorded participants' height in inches and weight in pounds. Weight and height measurements were used to calculate Body Mass Index using the formula: [weight (lb) / height (in)^2] x 703. This data is only available for the participants who participated in-person.	Change from baseline measurements at 12 weeks
Systolic Blood Pressure	Systolic pressures were measured in mmHg using a blood pressure cuff and sphygmomanometer. Two blood pressure readings were taken at each assessment point, and the average was used. This data is only available for the participants who were in-person.	Change from baseline measurements at 12 weeks
Diastolic Blood Pressure	Diastolic pressures were measured in mmHg using a blood pressure cuff and sphygmomanometer. Two blood pressure readings were taken at each assessment point, and the average was used. This data is only available for the participants who were in-person.	Change from baseline measurements at 12-weeks
Physical Activity Recall (PAR) - General Physical Activity	The Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of general physical activity, all activity that is of at least moderate intensity is counted and is reported as hours of activity in the past week.	Change from baseline PAR at 12 weeks
Physical Activity Recall (PAR) - Strength Activity	The Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of strength activity, time spent engaged in strength building activity over the past seven days is totaled and is reported as hours of strength activity in the past week.	Change from baseline PAR Strength time at 12 weeks
Physical Activity Recall (PAR) - Flexibility Activity	The Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of flexibility activity, time spent engaged in activity that involve flexibility over the past seven days is totaled and is reported as hours of flexibility activity in the past week.	Change from baseline PAR Flexibility time at 12 weeks
The Epidemic - Pandemic Impacts Inventory (EPII) - Negative Impacts	The Epidemic - Pandemic Impacts Inventory (EPII) is a 92-item questionnaire. This recently-developed measure was designed to learn about and describe the impact of the coronavirus disease pandemic on various domains of personal and family life, including employment, education, home life, social life, economic, physical health, infection experiences, and positive changes. This instrument was only administered to the remote participants, after the pandemic started. Participants were asked to respond to each item with one of the following four responses: 1) "Yes, me", 2) "Yes, person in home", 3) "no", and 4) "not applicable". Any "yes" response was coded as 1 and a "no" or "not applicable" response was coded as 0. Two scales were created (Positive Impacts and Negative Impacts) by summing the items for each scale. Negative Impacts are reported here (possible response range of 0-73), with higher scores indicating greater negative impact of the pandemic.	Change from baseline EPII at 12 weeks
The Epidemic - Pandemic Impacts Inventory (EPII) - Positive Impacts	The Epidemic - Pandemic Impacts Inventory (EPII) is a 92-item questionnaire. This recently-developed measure was designed to learn about and describe the impact of the coronavirus disease pandemic on various domains of personal and family life, including employment, education, home life, social life, economic, physical health, infection experiences, and positive changes. This instrument was only administered to the remote participants, after the pandemic started. Participants were asked to respond to each item with one of the following four responses: 1) "Yes, me", 2) "Yes, person in home", 3) "no", and 4) "not applicable". Any "yes" response was coded as 1 and a "no" or "not applicable" response was coded as 0. Two scales were created (Positive Impacts and Negative Impacts) by summing the items for each scale. Positive Impacts are reported here (possible response range of 0-18), with higher scores indicating greater positive impact of the pandemic.	Change from baseline EPII at 12 weeks Change from baseline EPII at 12-weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Boston University; Tufts Medical Center
• Investigators: Principal Investigator: Barbara L. Niles, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; Principal Investigator: DeAnna L Mori, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications and helpful links

General 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.

Helpful Links

• IRB approved webpage - Novel Interventions for Gulf War Illness study

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimated): January 25, 2016

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Tai Chi; Gulf War Illness; Wellness; Mind-body; Gulf War Veteran's Illness; GWVI
• Other Study ID Numbers: SPLD-004-15S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No