FM and PTSDEXFMPTSDNCT03236467
Neurohormonal Benefits of Exercise in Fibromyalgia and PTSD
A study testing Progressive Exercise Training in people with FM and PTSD, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The most recent conflicts are creating a new generation of Veterans, including an increasing number of women Veterans, who present with comorbid PTSD and chronic pain conditions, including Fibromyalgia (FM), from deployment-related physical injuries and exposure to psychological trauma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- FM and PTSD
- What is being tested?
- Progressive Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Only Veteran and civilian participants in whom a physical examination and medical history indicate that the participant meets current diagnostic criteria for FM, as specified by the American College of Rheumatology, will be eligible for the study.
- Eligible participants who agree to a blood draw for measurement of biomarkers, must be free of medications and other substances (e.g., illicit drugs and alcohol) that may alter results for 2-6 weeks depending on the medication and frequency of use (which must be cleared by MD consultants).
- If on pain medications with short half-lives, participants must be off of them for 5 half-lives before testing, generally about 24 hours.
- Any FM participant with an ICD-10 chronic pain diagnosis of a musculoskeletal etiology, will also be eligible for inclusion in the study as many individuals with FM also have such conditions.
- Any participant with a confirmed psychiatric diagnosis of PTSD will be included in the study. Individuals in the PTSD group must meet diagnostic criteria for current chronic PTSD (>3 months) as assessed by the CAPS-5, 1-Month Diagnostic Version.
Who cannot join
- 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 (except for Psychosis NOS due to PTSD-related sensory hallucinations)
- Untreated bipolar disorder
- Or active suicidal or homicidal ideation requiring clinical intervention
- Individuals with current or past alcohol and/or substance dependence (less than three months from date of screening assessment) will be excluded
- Individuals seeking interventional pain treatment, such as surgical interventions or other pain clinic interventions, will also be excluded unless they agree to participate in the biomarker procedure prior to the start of their pain intervention.
- Finally, participants who have a neuropathic origin to their pain will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
Official title: Neurobiological and Psychological Benefits of Exercise in Fibromyalgia and PTSD
The most recent conflicts are creating a new generation of Veterans, including an increasing number of women Veterans, who present with comorbid PTSD and chronic pain conditions, including Fibromyalgia (FM), from deployment-related physical injuries and exposure to psychological trauma. Health behavior change is important in treating these conditions and proactively preventing long-term negative health sequelae, in order to benefit these Veterans directly and reduce the challenges to our healthcare system. The proposed SPiRE application will use an innovative translational research approach to study whether a progressive -based exercise program will reduce FM 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.
Read the detailed description
Due to the COVID-19 pandemic, and after consultation with the appropriate research oversight, this study is temporarily suspended as of 3/15/20.
This study will compare the effects of a 12-week progressive exercise training program on 1) Fibromyalgia (FM) pain and PTSD symptoms, 2) pain threshold and tolerance, and 3) relevant biomarkers and neuromodulators including: a) anti-stress, anti-nociceptive, immune modulating factors such as neuropeptide Y (NPY) and GABAergic neuroactive steroids such as allopregnanolone and pregnanolone (together termed ALLO) b) factors that upregulate the expression of NPY and the GABAergic neuroactive steroids, and otherwise modulate inflammation, such as cortisol, c) excitatory factors such as substance P that directly promote pain transduction and d) pro-inflammatory cytokines such as IL-6 and IL-8 that not only increase pain and inflammation, but also contribute to psychological dysfunction (e.g. anhedonia and depression) via impact on the CNS reward system. This study will focus on Veterans with FM/PTSD. The study design includes a baseline, acute, 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 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" CPX assessment will occur at week 13 to track changes in psychological and neurobiological factors and to delineate their impact on pain and PTSD symptoms. Both CPX, maximum load, exercise tests will be performed in accordance with guidelines published by the American College of Cardiology. Among Veterans with FM/PTSD, changes in the biomarkers assessed after acute, CPX exercise testing will be associated with improvements in pain and PTSD symptoms.
Once identified, such biomarkers could be augmented by modification of the exercise regimen to help enhance the anti-stress hormone levels for the FM/PTSD population and experience clinically significant reductions in their symptoms. To obtain sufficient power, 36 participants (18/year) will be recruited. Data from this pilot work will be used to demonstrate feasibility and inform the further development of individually prescribed exercise regimens and a motivationally based exercise behavior change intervention aimed at reducing chronic musculoskeletal pain, including FM, and PTSD symptoms in Veterans. In the short-term, this SPiRE proposal will allow the PI to develop a more effective, motivationally based, exercise behavior change protocol that fosters long-term exercise adherence in patients with FM/PTSD. In the long-term, 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 year 2 of the current SPiRE proposal.
- Conditions
- FM and PTSD
- Being tested
- Progressive Exercise Training
- Keywords
- Fibromyalgia and PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Exercise TrainingBehavioural
Designed to ease primarily sedentary individuals into exercise training, increasing in intensity up to 80% of maximum Heart Rate Range over time.
| Study group | Role | What they receive |
|---|---|---|
| FM + PTSD | Experimental | Individuals suffering from Fibromyalgia and PTSD Receives: Behavioral: Progressive Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire-Revised
The FIQR has been found to be a useful and brief instrument to assess the overall impact and severity of FM.
The FIQR consists of 21-items that assess pain, fatigue, stiffness, sleep, depression, memory, anxiety, balance, and environment sensitivity.
All items are framed in the past 7 days and are scored on an 11-point numeric rating scores of 0 to 10.
The total score ranges from 0 to 100, with higher scores representing greater symptom burden and functional limitations.
Measured: Two Years
Secondary outcomes (1)
Clinician Administered PTSD Scale -5
This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS-5 is currently in the process of being validated however its previous version demonstrated excellent sensitivity (.81) and specificity (.95).57
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Jan 2018
- Primary completion29 Apr 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FM and PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using an innovative translational research approach to study whether a 12 week-progressive - exercise program will reduce FM pain in patients with PTSD and to elucidate and modify potential PTSD-related deficiencies in neurobiological and psychological responses to exercise
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Boston Healthcare System
- Responsible party
- Sponsor
- Investigators
- Erica R. Scioli, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236467
- Sponsor's protocol ID
- D2395-P
- Other IDs
- 1I21RX002395-01A1
- Acronym
- EXFMPTSD
- Status last verified
- Nov 2022
- First submitted
- 27 Jul 2017
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is a VABHS single site study. There are no plans to share the data outside of the VA Boston Healthcare System, unless specifically requested by authorized officials of VA.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological and Psychological Benefits of Exercise in Fibromyalgia and PTSD
- ClinicalTrials.gov ID
- NCT03236467
- Acronym / sponsor ID
- EXFMPTSD / D2395-P
- Conditions
- FM and PTSD
- Keywords
- Fibromyalgia and PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Boston Healthcare System
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The most recent conflicts are creating a new generation of Veterans, including an increasing number of women Veterans, who present with comorbid PTSD and chronic pain conditions, including Fibromyalgia (FM), from deployment-related physical injuries and exposure to psychological trauma. Health behavior change is important in treating these conditions and proactively preventing long-term negative health sequelae, in order to benefit these Veterans directly and reduce the challenges to our healthcare system. The proposed SPiRE application will use an innovative translational research approach to study whether a progressive -based exercise program will reduce FM 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.
Detailed description
Due to the COVID-19 pandemic, and after consultation with the appropriate research oversight, this study is temporarily suspended as of 3/15/20.
This study will compare the effects of a 12-week progressive exercise training program on 1) Fibromyalgia (FM) pain and PTSD symptoms, 2) pain threshold and tolerance, and 3) relevant biomarkers and neuromodulators including: a) anti-stress, anti-nociceptive, immune modulating factors such as neuropeptide Y (NPY) and GABAergic neuroactive steroids such as allopregnanolone and pregnanolone (together termed ALLO) b) factors that upregulate the expression of NPY and the GABAergic neuroactive steroids, and otherwise modulate inflammation, such as cortisol, c) excitatory factors such as substance P that directly promote pain transduction and d) pro-inflammatory cytokines such as IL-6 and IL-8 that not only increase pain and inflammation, but also contribute to psychological dysfunction (e.g. anhedonia and depression) via impact on the CNS reward system. This study will focus on Veterans with FM/PTSD. The study design includes a baseline, acute, 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 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" CPX assessment will occur at week 13 to track changes in psychological and neurobiological factors and to delineate their impact on pain and PTSD symptoms. Both CPX, maximum load, exercise tests will be performed in accordance with guidelines published by the American College of Cardiology. Among Veterans with FM/PTSD, changes in the biomarkers assessed after acute, CPX exercise testing will be associated with improvements in pain and PTSD symptoms.
Once identified, such biomarkers could be augmented by modification of the exercise regimen to help enhance the anti-stress hormone levels for the FM/PTSD population and experience clinically significant reductions in their symptoms. To obtain sufficient power, 36 participants (18/year) will be recruited. Data from this pilot work will be used to demonstrate feasibility and inform the further development of individually prescribed exercise regimens and a motivationally based exercise behavior change intervention aimed at reducing chronic musculoskeletal pain, including FM, and PTSD symptoms in Veterans. In the short-term, this SPiRE proposal will allow the PI to develop a more effective, motivationally based, exercise behavior change protocol that fosters long-term exercise adherence in patients with FM/PTSD. In the long-term, 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 year 2 of the current SPiRE proposal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Using an innovative translational research approach to study whether a 12 week-progressive - exercise program will reduce FM pain in patients with PTSD and to elucidate and modify potential PTSD-related deficiencies in neurobiological and psychological responses to exercise
| Arm | Type | Receives |
|---|---|---|
| FM + PTSD | Experimental | Behavioral: Progressive Exercise TrainingIndividuals suffering from Fibromyalgia and PTSD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Only Veteran and civilian participants in whom a physical examination and medical history indicate that the participant meets current diagnostic criteria for FM, as specified by the American College of Rheumatology, will be eligible for the study.
- Eligible participants who agree to a blood draw for measurement of biomarkers, must be free of medications and other substances (e.g., illicit drugs and alcohol) that may alter results for 2-6 weeks depending on the medication and frequency of use (which must be cleared by MD consultants).
- If on pain medications with short half-lives, participants must be off of them for 5 half-lives before testing, generally about 24 hours.
- Any FM participant with an ICD-10 chronic pain diagnosis of a musculoskeletal etiology, will also be eligible for inclusion in the study as many individuals with FM also have such conditions.
- Any participant with a confirmed psychiatric diagnosis of PTSD will be included in the study. Individuals in the PTSD group must meet diagnostic criteria for current chronic PTSD (>3 months) as assessed by the CAPS-5, 1-Month Diagnostic Version.
Key exclusion criteria (7 listed)
- 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 (except for Psychosis NOS due to PTSD-related sensory hallucinations)
- Untreated bipolar disorder
- Or active suicidal or homicidal ideation requiring clinical intervention
- Individuals with current or past alcohol and/or substance dependence (less than three months from date of screening assessment) will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Exercise TrainingDesigned to ease primarily sedentary individuals into exercise training, increasing in intensity up to 80% of maximum Heart Rate Range over time. | Behavioural | FM + PTSD |
Primary outcome
Fibromyalgia Impact Questionnaire-Revised
Time frame: Two Years
The FIQR has been found to be a useful and brief instrument to assess the overall impact and severity of FM. The FIQR consists of 21-items that assess pain, fatigue, stiffness, sleep, depression, memory, anxiety, balance, and environment sensitivity. All items are framed in the past 7 days and are scored on an 11-point numeric rating scores of 0 to 10. The total score ranges from 0 to 100, with higher scores representing greater symptom burden and functional limitations.
1 secondary outcome
Clinician Administered PTSD Scale -5
Time frame: Two Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Yes. This is a VABHS single site study. There are no plans to share the data outside of the VA Boston Healthcare System, unless specifically requested by authorized officials of VA.
Related trials for FM and PTSD
Not yet recruiting
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Fibromyalgia (FM), Posttraumatic Stress Disorder (PTSD)
RecruitingObservational study
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
Post-Acute COVID-19 Syndrome, ME/CFS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica R. Scioli, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Exercise Training in people with FM and PTSD, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire-Revised (time frame: Two Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.