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Exercise and Behavioral Therapy Trial (EBT).

25 juin 2015 mis à jour par: US Department of Veterans Affairs

CSP#470 - A Randomized, Multi-Center, Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses

This trial is a study of Gulf War era veterans who have unexplained chronic medical symptoms such as pain, fatigue, and/or cognitive difficulties. The treatments to be studied, cognitive behavior therapy (CBT) and aerobic exercise, have been shown to be effective in alleviating symptoms in individuals with other similar types of illnesses, such as chronic fatigue syndrome and fibromyalgia. This is a Phase 3, 2X2 factorial designed study. All study participants are assigned to one of four treatment groups - CBT and aerobic exercise, aerobic exercise alone, CBT alone or usual and customary care. This study durations is 28 months; 1092 participants were enrolled and will be followed in clinic at 3, 6 and 12 months after enrollment.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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:

  1. Both aerobic exercise and CBT will lead to improvements in the cardinal symptoms of GWVI: pain, fatigue and cognitive difficulties.
  2. Both aerobic exercise and CBT will lead to decreased levels of distress in persons with GWVI.
  3. 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.

Type d'étude

Interventionnel

Inscription

1064

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Porto Rico
      • San Juan, Porto Rico, 00921-3201
        • San Juan Vamc
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • Birmingham Vamc
      • Birmingham, Alabama, États-Unis, 35233
        • Birmingham Vamc Birmingham Vamc
    • California
      • San Diego, California, États-Unis, 92106-6000
        • Naval Health Research Center, San Diego
      • San Diego, California, États-Unis, 92152
        • Naval Health Research Center, San Diego
      • San Diego, California, États-Unis, 92186-5122
        • Naval Health Research Center, San Diego
      • San Francisco, California, États-Unis, 94121
        • San Francisco VAMC
    • Connecticut
      • West Haven, Connecticut, États-Unis, 06516
        • VA CT Healthcare System, West Haven
    • District of Columbia
      • Washington, District of Columbia, États-Unis, 20007
        • Georgetown University Medical Center
      • Washington, District of Columbia, États-Unis, 20307-5001
        • Walter Reed Army Medical Center
    • Maryland
      • Bethesda, Maryland, États-Unis, 20814-4799
        • Uniformed Services University
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02118
        • Boston Medical Center
      • Boston, Massachusetts, États-Unis, 02130
        • Boston Vamc
      • Boston, Massachusetts, États-Unis, 02114
        • Boston Vamc
    • Missouri
      • St. Louis, Missouri, États-Unis, 63106
        • John Cochran VAMC, Saint Louis
    • New Jersey
      • East Orange, New Jersey, États-Unis, 07018
        • VA New Jersey Health Care System, East Orange
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87108
        • Vamc - Albuquerque
    • New York
      • Brooklyn, New York, États-Unis, 11209
        • New York Harbor VA Healthcare System, Brooklyn Campus
    • North Dakota
      • Fargo, North Dakota, États-Unis, 58102
        • Fargo Vamc
    • Ohio
      • Dayton, Ohio, États-Unis, 45428
        • Vamc - Dayton
    • Oregon
      • Portland, Oregon, États-Unis, 97207
        • Portland Vamc
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Philadelphia Vamc
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Houston VAMC
      • San Antonio, Texas, États-Unis, 78284
        • Audie L. Murphy Memorial Veterans Hospital, San Antonio
    • Vermont
      • Burlington, Vermont, États-Unis
        • White River Junction VAMC
      • White River Jct., Vermont, États-Unis, 05009
        • White River Junction VAMC
    • Virginia
      • Richmond, Virginia, États-Unis, 23249
        • Richmond VAMC
    • Washington
      • Seattle, Washington, États-Unis, 98108-1597
        • VA Puget Sound Healthcare System, Seattle Division
      • Seattle, Washington, États-Unis, 98108
        • VA Puget Sound Healthcare System, Seattle Division

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Gulf War era veterans deployed to the South West Asia theater of operations between August 1990 and August 1991 who have two of the following three symptoms that began after 1990 lasting more than 6 months and continuing to present - fatigue that limits usual activities (work, recreation or social), musculoskeletal pain involving more than one region of the body or neurocognitive dysfunction (self-reported difficulties in memory, concentration, or attention).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Aucun (étiquette ouverte)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

US Department of Veterans Affairs

Collaborateurs

United States Department of Defense

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 1999

Achèvement de l'étude

1 août 2001

Dates d'inscription aux études

Première soumission

29 décembre 2000

Première soumission répondant aux critères de contrôle qualité

30 décembre 2000

Première publication (Estimation)

1 janvier 2001

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

26 juin 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 juin 2015

Dernière vérification

1 juin 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 470

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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