Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Neurology, Neurology, Psychiatric |
| Therapuetic Areas: | Musculoskeletal, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/17/2018 |
| Start Date: | October 1, 2013 |
| End Date: | April 1, 2020 |
| Contact: | Erica R Scioli, PhD |
| Email: | EricaRose.Scioli@va.gov |
| Phone: | (857) 364-5696 |
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 our 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 in patients
with PTSD 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.
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 our 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 in patients
with PTSD 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.
This study will explicitly compare the effects of a 12-week progressive exercise training
program on 1) the clinical symptoms of chronic pain and PTSD, 2) pain threshold and
tolerance, and 3) anti-stress, anti-nociceptive neurohormones such as neuropeptide Y (NPY)
and allopregnanolone/pregnanolone (ALLO) in Veterans with chronic pain/PTSD compared to
healthy comparison participants. 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 ability/capacity 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. Weekly 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, pain tolerance
(via the cold pressor test) will be implemented 30 minutes before and 30 minutes after
exercise testing as well as at a midpoint "check-in" at which self-report questionnaires will
also be repeated. Based on the PI's earlier research, the role of exercise motivation and
self-efficacy on changes in perceived pain and pain tolerance will be correlated with changes
in NPY and ALLO levels, pre and post exercise. It is anticipated that differences in
biological responses to aerobic and anaerobic exercise between healthy participants and those
with chronic pain/PTSD 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 pain/PTSD population and experience clinically significant reductions in their
symptoms. In order to obtain sufficient power as well as accounting for an expected drop-out
rate of 18-20%, the proposed recruitment is 30 participants per condition (total of 60
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 PI's
long-term goal of becoming an independent scientist/practitioner in the VA focused on
development of improved treatments for health conditions co-morbid with PTSD such as chronic
pain and mild 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 chronic pain/PTSD. 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.
program on 1) the clinical symptoms of chronic pain and PTSD, 2) pain threshold and
tolerance, and 3) anti-stress, anti-nociceptive neurohormones such as neuropeptide Y (NPY)
and allopregnanolone/pregnanolone (ALLO) in Veterans with chronic pain/PTSD compared to
healthy comparison participants. 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 ability/capacity 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. Weekly 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, pain tolerance
(via the cold pressor test) will be implemented 30 minutes before and 30 minutes after
exercise testing as well as at a midpoint "check-in" at which self-report questionnaires will
also be repeated. Based on the PI's earlier research, the role of exercise motivation and
self-efficacy on changes in perceived pain and pain tolerance will be correlated with changes
in NPY and ALLO levels, pre and post exercise. It is anticipated that differences in
biological responses to aerobic and anaerobic exercise between healthy participants and those
with chronic pain/PTSD 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 pain/PTSD population and experience clinically significant reductions in their
symptoms. In order to obtain sufficient power as well as accounting for an expected drop-out
rate of 18-20%, the proposed recruitment is 30 participants per condition (total of 60
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 PI's
long-term goal of becoming an independent scientist/practitioner in the VA focused on
development of improved treatments for health conditions co-morbid with PTSD such as chronic
pain and mild 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 chronic pain/PTSD. 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.
Inclusion Criteria:
- Only Veteran and civilian participants in whom a physical examination, medical
history, EKG, and baseline laboratory studies including urine toxicology screens
indicate that maximum load exercise testing will be safe will be included in this
study.
- Participants must be free of medications and other substances, (e.g., illicit drugs
and alcohol) with effects that could hinder data interpretation for 2-6 weeks
depending on the medication and frequency of use (which must be cleared by the PI's
primary mentor).
- If on pain medications with short half-lives, must be off of them for 5 half-lives
before testing, generally about 24 hours.
- Any participant with an ICD9 chronic pain diagnosis, with a musculoskeletal etiology,
as confirmed by the study rehab medicine doctor, will be allowed for inclusion in the
study.
- Also, any participant with a confirmed psychiatric diagnosis of PTSD (PTSD/chronic
pain group)
- or have trauma exposure without a diagnosis of PTSD
- other psychiatric conditions
- or chronic pain (healthy comparison group) will also be included in the study.
- Individuals in the PTSD groups must meet for current chronic PTSD (>3 months ) as
assessed by the CAPS 1-Month Diagnostic Version.
- Healthy trauma exposed individuals must have met criteria for an A1 event, but not
necessarily A2.
- Finally, healthy, trauma-exposed control participants with a maximum of one major
depressive episode in their past will be included in the study.
Exclusion Criteria:
- Veteran and civilian participants will be excluded from participation in the study if
they have:
- a life threatening or acute physical illness (e.g., cancer)
- current schizophreniform illnesses or bipolar disorder
- or active suicidal or homicidal ideation requiring clinical intervention.
- Women participants who are pregnant or are intending to become pregnant within the
next six months will be excluded from participation.
- Individuals with current or past alcohol and/or substance dependence (less than three
months from date of screening assessment) will be excluded.
- Healthy individuals with current partial PTSD (1 criterion B, < 3 criterion C; <2
criterion D)
- or presently healthy individuals with a past or lifetime diagnosis of PTSD
- greater than one major depressive episode or diagnosis of another serious
psychiatric illness in their past, e.g.:
- bipolar disorder or a schizophreniform disorder except for Psychosis not
otherwise specified due to PTSD-related sensory hallucinations.
- Individuals seeking pain treatment such as surgical interventions or who have a
neuropathic origin to their pain will also be excluded.
- Participants with chronic pain concerns that cannot tolerate exercising in a reclining
bike and those who have had a clinical history of coronary artery disease or positive
stress test
- Uncontrolled cardiac arrhythmia
- Moderate-to-severe aortic stenosis
- Severe arterial hypertension (systolic >200 mmHg, diastolic>110 mm Hg)
- More than first degree atrioventricular block also will be excluded from
participation.
- Finally, participants who screen positive by answering all four items on the TBI
assessment, will be excluded from participation.
We found this trial at
1
site
Boston, Massachusetts 02130
Principal Investigator: Erica R. Scioli, PhD
Phone: 857-364-4802
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