Exercise and Behavioral Therapy Trial (EBT).
CSP#470 - A Randomized, Multi-Center, Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses
調査の概要
詳細な説明
Primary Hypothesis:
The primary hypothesis is that both aerobic exercise and cognitive behavioral therapy (CBT) will significantly improve physical function (as measured by the Physical Component Summary Scale of the SF-36V) in veterans with Gulf War Veterans' Illnesses (GWVI), and the combination of cognitive behavioral therapy and aerobic exercise will be more beneficial than either therapy alone.
Secondary Hypotheses:
- Both aerobic exercise and CBT will lead to improvements in the cardinal symptoms of GWVI: pain, fatigue and cognitive difficulties.
- Both aerobic exercise and CBT will lead to decreased levels of distress in persons with GWVI.
- Both aerobic exercise and CBT will lead to improvements in emotional functioning in persons with GWVI.
Primary Outcomes: Improvement on the Physical Component Summary Scale of the SF-36V of more than 7 units at one year relative to baseline.
Interventions: Twelve one-hour weekly sessions of Cognitive behavioral therapy, aerobic exercise, the combination of the two therapies (12 one-hour sessions of CBT and 12 one-hour sessions of aerobic exercise) and a control group that receives usual and customary care.
Study Abstract: This trial was a study of Gulf War era veterans who have unexplained chronic medical symptoms such as pain, fatigue, and/or cognitive difficulties. All Gulf War veterans who were deployed to the South West Asia theater of operations between August 1990 and August 1991 were eligible for the study if they had at least two of the following three symptoms that began after August of 1990, lasting for more than six months and occurring up to present: 1. fatigue that limits usual activities (work, recreation, or social), 2. musculoskeletal pain involving two or more regions of the body, and neuro-cognitive dysfunction (self-reported difficulties in memory, concentration, or attention). Veterans who met enrollment criteria were randomized to one of four treatment arms: 1. CBT plus aerobic exercise, 2. aerobic exercise alone, 3. CBT alone, and 4. usual and customary care. Treatment was given for three months in group format. The CBT and exercise groups met for one hour, once a week for 12 weeks for a total of 12 hourly sessions. The interventions were standardized and all investigators were trained in the use of these methods prior to start up of the trial. The target sample size was 1064 veterans with GWVI to be accrued from 20 Medical Centers (18 VA and 2 DOD). All veterans were followed for one year and outcomes measured at 3 months (immediately following the end of treatment), 6 months and 12 months after enrollment.
The study was kicked-off in April 1999 and enrollment ended on September 5, 2000, during which 1092 veterans were randomized. Patient follow-up concluded on September 30, 2001 and the final DSMB meeting was held on November 28, 2001. The major finding was that there were no significant differences in the proportion of veterans who reported an improvement in physical function at one year among the treatment groups (11.5% for usual care, 11.7% for exercise, 18.4% for CBT and 18.5% for CBT + exercise). However, statistically significant improvements in fatigue, cognitive symptoms, distress, and mental health functioning were observed with exercise alone and with exercise plus CBT compared to usual care. CBT alone had a statistically significant effect on cognitive symptoms and in mental health functioning. Except for affective pain, which improved with CBT alone or with exercise, neither treatment had a significant effect on the other three measures of pain. In summary, neither exercise nor CBT had a significant impact on physical function for veterans with GWVI but both treatments, especially exercise, resulted in improvement in fatigue, cognitive symptoms, distress and mental health functioning.
Results embargoed until publication.
研究の種類
入学
段階
- フェーズ 3
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35233
- Birmingham Vamc
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Birmingham、Alabama、アメリカ、35233
- Birmingham Vamc Birmingham Vamc
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California
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San Diego、California、アメリカ、92106-6000
- Naval Health Research Center, San Diego
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San Diego、California、アメリカ、92152
- Naval Health Research Center, San Diego
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San Diego、California、アメリカ、92186-5122
- Naval Health Research Center, San Diego
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San Francisco、California、アメリカ、94121
- San Francisco VAMC
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Connecticut
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West Haven、Connecticut、アメリカ、06516
- VA CT Healthcare System, West Haven
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District of Columbia
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Washington、District of Columbia、アメリカ、20007
- Georgetown University Medical Center
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Washington、District of Columbia、アメリカ、20307-5001
- Walter Reed Army Medical Center
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Maryland
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Bethesda、Maryland、アメリカ、20814-4799
- Uniformed Services University
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Boston Medical Center
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Boston、Massachusetts、アメリカ、02130
- Boston Vamc
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Boston、Massachusetts、アメリカ、02114
- Boston Vamc
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Missouri
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St. Louis、Missouri、アメリカ、63106
- John Cochran VAMC, Saint Louis
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New Jersey
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East Orange、New Jersey、アメリカ、07018
- VA New Jersey Health Care System, East Orange
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New Mexico
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Albuquerque、New Mexico、アメリカ、87108
- Vamc - Albuquerque
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New York
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Brooklyn、New York、アメリカ、11209
- New York Harbor VA Healthcare System, Brooklyn Campus
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North Dakota
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Fargo、North Dakota、アメリカ、58102
- Fargo Vamc
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Ohio
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Dayton、Ohio、アメリカ、45428
- Vamc - Dayton
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Oregon
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Portland、Oregon、アメリカ、97207
- Portland Vamc
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Philadelphia Vamc
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Texas
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Houston、Texas、アメリカ、77030
- Houston Vamc
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San Antonio、Texas、アメリカ、78284
- Audie L. Murphy Memorial Veterans Hospital, San Antonio
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Vermont
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Burlington、Vermont、アメリカ
- White River Junction VAMC
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White River Jct.、Vermont、アメリカ、05009
- White River Junction VAMC
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Virginia
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Richmond、Virginia、アメリカ、23249
- Richmond VAMC
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Washington
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Seattle、Washington、アメリカ、98108-1597
- VA Puget Sound Healthcare System, Seattle Division
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Seattle、Washington、アメリカ、98108
- VA Puget Sound Healthcare System, Seattle Division
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San Juan、プエルトリコ、00921-3201
- San Juan Vamc
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:階乗代入
- マスキング:なし(オープンラベル)
協力者と研究者
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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