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.|
|ClinicalTrials.gov Identifier: NCT03236467|
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : November 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|FM and PTSD||Behavioral: Progressive Exercise Training||Early Phase 1|
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 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)|
|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|
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.
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03236467
|Contact: Erica R Scioli, PhD||(857) 364-5696||EricaRose.Scioli@va.gov|
|Contact: Ann Rasmusson, MD||(857) 364-4807 ext firstname.lastname@example.org|
|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 email@example.com|
|Contact: Maria Higgins (857) 364-4802 firstname.lastname@example.org|
|Principal Investigator: Erica R. Scioli, PhD|
|Principal Investigator:||Erica R. Scioli, PhD||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|