Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03283163
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2017-09-11
Brief Title:
Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
EXCPPTSD
Brief Summary:
The wars in Iraq and Afghanistan are creating a new generation of Veterans including an increasing number of women Veterans who present with comorbid PTSD and chronic pain conditions from recent deployment-related physical injuries and exposure to psychological trauma Health behavior change has become increasingly important in treating these conditions and proactively preventing long-term negative health sequelae in order to benefit these Veterans directly and reduce the growing challenges to the healthcare system The proposed CDA-2 program of research will use an innovative translational research approach to study whether a chronic progressive -based exercise program will reduce chronic pain symptoms in patients with varying degrees of PTSD symptom severity and to elucidate and modify potential PTSD-related deficiencies in neurobiological and psychological responses to exercise to optimize the physical and psychological benefits of exercise for these individuals
Detailed Description:
Due to the COVID-19 pandemic and after consultation with the appropriate research oversight all study procedures are temporarily suspended as of 31520
This study will explicitly examine the effects of a 12-week progressive exercise training program on 1 the clinical symptoms of chronic pain and varying degrees of PTSD symptom severity 2 anti-stress anti-nociceptive neurohormones such as allopregnanolone pregnanolone ALLO PA in Veterans with trauma exposure chronic pain and varying degrees of PTSD symptom severity The revised study design includes a baseline cardiopulmonary exercise assessment CPX that will inform the exercise prescription for a 12-week progressive exercise training program comprised of three 30-45 minute exercise sessions per week walking or running depending on the abilitycapacity of the participant Exercise sessions will be initially supervised by an exercise physiologist in the Clinical Studies Unit CSU at the VA Boston Healthcare System and then each participant will transition into the home Intermittent telephone calls by the PI will provide additional motivational support and assistance with problem solving Implementation of the prescribed exercise regimen will also be supported by the use of heart rate and actigraph monitors programmed for the participant to achieve their prescribed heart rate range HRR Finally an endpoint maximum load exercise assessment will occur at week 13 in order to track measurable change for both psychological and neurobiological factors and to delineate their impact on pain indices and PTSD symptomatology Both maximum load exercise tests will be performed in accordance with guidelines published by the American College of Cardiology Measures of pain symptomatology will be implemented 30 minutes before and 30 minutes after exercise testing at baseline and endpoint It is anticipated that differences in biological responses to aerobic and anaerobic exercise as illustrated by variability among the participants with varying degrees of PTSD symptom severity will predict differences in the psychological and pain-reducing benefits of aerobic and anaerobic exercise Once identified such factors could be augmented by modification of the exercise regimen in order to help enhance the ant-stress hormone levels for the painPTSD population and experience clinically significant reductions in their symptoms In order to obtain sufficient power the proposed recruitment is 23 participants Data from this pilot work will be used to compute effect sizes in support of a future clinical trial incorporating individually prescribed exercise regimens and a motivationally based exercise behavior change intervention aimed at reducing pain and PTSD symptoms in our Veterans Advanced education and training is sought by this CDA-2 award applicant in four broad areas 1 psychophysiology of chronic pain and PTSD with a sub-focus on sex differences 2 the neurobiology of chronic stress PTSD and pain 3 exercise physiology and 4 the neuropsychology and neurobiology of traumatic brain injury TBI The combination of didactic and experiential training in these areas will serve the PIs long-term goal of becoming an independent scientistpractitioner in the VA focused on development of improved treatments for health conditions co-morbid with PTSD such as chronic pain and mild to moderate TBI In the shorter-term this CDA-2 will allow the PI to develop a more effective motivationally based exercise behavior change protocol that fosters long-term exercise compliance in patients with trauma-exposure chronic pain and varying degrees of PTSD symptom severity This intervention will be used as an adjunct to cognitive interventions for these disorders to be further developed and studied via a larger VA NIH or DOD-funded grant for which the PI will apply in years 4-5 of the CDA2
This study will explicitly examine the effects of a 12-week progressive exercise training program on 1 the clinical symptoms of chronic pain and varying degrees of PTSD symptom severity 2 anti-stress anti-nociceptive neurohormones such as allopregnanolone pregnanolone ALLO PA in Veterans with trauma exposure chronic pain and varying degrees of PTSD symptom severity The revised study design includes a baseline cardiopulmonary exercise assessment CPX that will inform the exercise prescription for a 12-week progressive exercise training program comprised of three 30-45 minute exercise sessions per week walking or running depending on the abilitycapacity of the participant Exercise sessions will be initially supervised by an exercise physiologist in the Clinical Studies Unit CSU at the VA Boston Healthcare System and then each participant will transition into the home Intermittent telephone calls by the PI will provide additional motivational support and assistance with problem solving Implementation of the prescribed exercise regimen will also be supported by the use of heart rate and actigraph monitors programmed for the participant to achieve their prescribed heart rate range HRR Finally an endpoint maximum load exercise assessment will occur at week 13 in order to track measurable change for both psychological and neurobiological factors and to delineate their impact on pain indices and PTSD symptomatology Both maximum load exercise tests will be performed in accordance with guidelines published by the American College of Cardiology Measures of pain symptomatology will be implemented 30 minutes before and 30 minutes after exercise testing at baseline and endpoint It is anticipated that differences in biological responses to aerobic and anaerobic exercise as illustrated by variability among the participants with varying degrees of PTSD symptom severity will predict differences in the psychological and pain-reducing benefits of aerobic and anaerobic exercise Once identified such factors could be augmented by modification of the exercise regimen in order to help enhance the ant-stress hormone levels for the painPTSD population and experience clinically significant reductions in their symptoms In order to obtain sufficient power the proposed recruitment is 23 participants Data from this pilot work will be used to compute effect sizes in support of a future clinical trial incorporating individually prescribed exercise regimens and a motivationally based exercise behavior change intervention aimed at reducing pain and PTSD symptoms in our Veterans Advanced education and training is sought by this CDA-2 award applicant in four broad areas 1 psychophysiology of chronic pain and PTSD with a sub-focus on sex differences 2 the neurobiology of chronic stress PTSD and pain 3 exercise physiology and 4 the neuropsychology and neurobiology of traumatic brain injury TBI The combination of didactic and experiential training in these areas will serve the PIs long-term goal of becoming an independent scientistpractitioner in the VA focused on development of improved treatments for health conditions co-morbid with PTSD such as chronic pain and mild to moderate TBI In the shorter-term this CDA-2 will allow the PI to develop a more effective motivationally based exercise behavior change protocol that fosters long-term exercise compliance in patients with trauma-exposure chronic pain and varying degrees of PTSD symptom severity This intervention will be used as an adjunct to cognitive interventions for these disorders to be further developed and studied via a larger VA NIH or DOD-funded grant for which the PI will apply in years 4-5 of the CDA2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1k2 RX000704 | OTHER_GRANT | VA RRD | None |