Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007748
Status:
COMPLETED
Last Update Posted:
2015-06-26
First Post:
2000-12-29
Brief Title:
Exercise and Behavioral Therapy Trial EBT
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP470 - A Randomized Multi-Center Controlled Trial of Multi-Modal Therapy in Veterans With Gulf War Illnesses
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is a study of Gulf War era veterans who have unexplained chronic medical symptoms such as pain fatigue andor 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
Detailed Description:
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 andor 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 115 for usual care 117 for exercise 184 for CBT and 185 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
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 andor 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 115 for usual care 117 for exercise 184 for CBT and 185 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None