Novel Interventions for GWVI

Not Applicable

Active, not recruiting

• Conditions: Gulf War Veteran's Illness
• Interventions: Behavioral: Tai Chi Intervention; Behavioral: Wellness Intervention

• Registration Number: NCT02661997
• Lead Sponsor: VA Office of Research and Development

Brief 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.

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 Timeline

• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Study Start: 2017-06-01
• Primary Completion: 2023-09-29
• Results First Submitted: 2024-09-24
• Results First Submitted QC: 2024-10-16
• Status Verified: 2024-11
• Results First Posted: 2024-11-07
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-12-02
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 114

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tai Chi Intervention	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	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.

Primary Outcome Measures

Name	Time	Method
Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference	Change from baseline to post-treatment at 12 weeks	The 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. Although initially developed to assess pain in patients with cancer, 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	Change from baseline to post-treatment at 12 weeks	The 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. Although initially developed to assess pain in patients with cancer, 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.

Secondary Outcome Measures

Name	Time	Method
Change in Multi-dimensional Fatigue Inventory (MFI-20)	Change from baseline to post-treatment at 12 weeks	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.
PROMIS Global Health Scale - Physical Health Subscale	Change from baseline to post-treatment at 12 weeks	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.
50 Foot Walk Test	Change from baseline to post-treatment (12 weeks)	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.
Short Physical Performance Battery (SPPB) - 4-Meter Walk Test	Change from baseline to post-treatment at 12 weeks	The 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 in Trail Making Test (TMT) - Trails A	Change from baseline to post-treatment at 12 weeks	The 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 in Hopkins Verbal Learning Test - Revised (HVLT-R)	Change from baseline to post-treatment at 12 weeks	The 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. Higher scores reflect better a better outcome.
PROMIS Global Health Scale - Mental Health Subscale	Change from baseline to post-treatment at 12 weeks	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.
Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)	Change from baseline to post-treatment at 12 weeks	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 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.
Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)	Change from baseline to post-treatment at 12 weeks	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 in Trail Making Test (TMT) - Trails B	Change from baseline to post-treatment at 12 weeks	The 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.

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States