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Neurohormonal Benefits of Exercise in Fibromyalgia and PTSD (EXFMPTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03236467
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : April 18, 2019
VA Boston Healthcare System
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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. 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.

Condition or disease Intervention/treatment Phase
FM and PTSD Behavioral: Progressive Exercise Training Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Neurobiological and Psychological Benefits of Exercise in Fibromyalgia and PTSD
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FM + PTSD
Individuals suffering from Fibromyalgia and PTSD
Behavioral: Progressive Exercise Training
Designed to ease primarily sedentary individuals into exercise training, increasing in intensity up to 80% of maximum Heart Rate Range over time.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Clinician Administered PTSD Scale -5 [ Time Frame: Two Years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03236467

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Contact: Erica R Scioli, PhD (857) 364-5696
Contact: Ann Rasmusson, MD (857) 364-4807 ext 44807

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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Terence M Keane, PhD    857-364-4551   
Contact: Maria Higgins    (857) 364-4802   
Principal Investigator: Erica R. Scioli, PhD         
Sponsors and Collaborators
VA Office of Research and Development
VA Boston Healthcare System
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Principal Investigator: Erica R. Scioli, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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Responsible Party: VA Office of Research and Development Identifier: NCT03236467     History of Changes
Other Study ID Numbers: D2395-P
1I21RX002395-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Fibromyalgia and PTSD

Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases