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Exercise and Behavioral Therapy Trial (EBT).

25 giugno 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione

1064

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

US Department of Veterans Affairs

Collaboratori

United States Department of Defense

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 1999

Completamento dello studio

1 agosto 2001

Date di iscrizione allo studio

Primo inviato

29 dicembre 2000

Primo inviato che soddisfa i criteri di controllo qualità

30 dicembre 2000

Primo Inserito (Stima)

1 gennaio 2001

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 giugno 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2015

Ultimo verificato

1 giugno 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 470

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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