- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00007748
Exercise and Behavioral Therapy Trial (EBT).
CSP#470 - A Randomized, Multi-Center, Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35233
- Birmingham Vamc
-
Birmingham, Alabama, Estados Unidos, 35233
- Birmingham Vamc Birmingham Vamc
-
-
California
-
San Diego, California, Estados Unidos, 92106-6000
- Naval Health Research Center, San Diego
-
San Diego, California, Estados Unidos, 92152
- Naval Health Research Center, San Diego
-
San Diego, California, Estados Unidos, 92186-5122
- Naval Health Research Center, San Diego
-
San Francisco, California, Estados Unidos, 94121
- San Francisco VAMC
-
-
Connecticut
-
West Haven, Connecticut, Estados Unidos, 06516
- VA CT Healthcare System, West Haven
-
-
District of Columbia
-
Washington, District of Columbia, Estados Unidos, 20007
- Georgetown University Medical Center
-
Washington, District of Columbia, Estados Unidos, 20307-5001
- Walter Reed Army Medical Center
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20814-4799
- Uniformed Services University
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
-
Boston, Massachusetts, Estados Unidos, 02130
- Boston Vamc
-
Boston, Massachusetts, Estados Unidos, 02114
- Boston Vamc
-
-
Missouri
-
St. Louis, Missouri, Estados Unidos, 63106
- John Cochran VAMC, Saint Louis
-
-
New Jersey
-
East Orange, New Jersey, Estados Unidos, 07018
- VA New Jersey Health Care System, East Orange
-
-
New Mexico
-
Albuquerque, New Mexico, Estados Unidos, 87108
- Vamc - Albuquerque
-
-
New York
-
Brooklyn, New York, Estados Unidos, 11209
- New York Harbor VA Healthcare System, Brooklyn Campus
-
-
North Dakota
-
Fargo, North Dakota, Estados Unidos, 58102
- Fargo Vamc
-
-
Ohio
-
Dayton, Ohio, Estados Unidos, 45428
- Vamc - Dayton
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97207
- Portland Vamc
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Philadelphia Vamc
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- Houston Vamc
-
San Antonio, Texas, Estados Unidos, 78284
- Audie L. Murphy Memorial Veterans Hospital, San Antonio
-
-
Vermont
-
Burlington, Vermont, Estados Unidos
- White River Junction VAMC
-
White River Jct., Vermont, Estados Unidos, 05009
- White River Junction VAMC
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23249
- Richmond VAMC
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98108-1597
- VA Puget Sound Healthcare System, Seattle Division
-
Seattle, Washington, Estados Unidos, 98108
- VA Puget Sound Healthcare System, Seattle Division
-
-
-
-
-
San Juan, Puerto Rico, 00921-3201
- San Juan Vamc
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 470
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Terapia de conducta cognitiva
-
University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
-
Assistance Publique - Hôpitaux de ParisAún no reclutandoPérdida de la audición | Función cognitiva | Función ejecutiva | Función vestibularFrancia
-
NeuroTronik Inc.DesconocidoInsuficiencia cardiaca | Insuficiencia cardíaca agudaParaguay
-
University of Roma La SapienzaTerminadoImplante dental fallido | Mucositis BucalItalia
-
NeuroTronik Inc.DesconocidoTerapia de estimulación autónoma del gasto cardíaco para la insuficiencia cardíaca aguda (COAST-AHF)Insuficiencia cardíaca agudaPanamá
-
Vyaire MedicalAún no reclutandoSíndrome de insuficiencia respiratoria del recién nacidoItalia
-
Boston Children's HospitalTerminadoEstrés Psicológico | Problema de aculturaciónEstados Unidos
-
Abbott Medical DevicesTerminadoFlutter auricular típicoEstados Unidos, Canadá
-
Abbott Medical DevicesTerminadoFibrilación auricular paroxísticaAustralia, Alemania, Francia, Italia, Portugal, Reino Unido
-
Square2 Systems, Inc.National Institute on Drug Abuse (NIDA)ReclutamientoTrastornos relacionados con sustancias | Trastornos por uso de sustanciasEstados Unidos