Clinical trial · Interventional
Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD
NCT03283163CI-TRIAL-00079817EXCPPTSDcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Musculoskeletal Pain | — | UNRESOLVED | — |
| Mild or Moderate Traumatic Brain Injury | — | UNRESOLVED | — |
| Posttraumatic Stress Disorder (PTSD) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Testing and Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chronic Pain//PTSD group
- description
- This group of trauma-exposed participants with chronic musculoskeletal pain and varying degrees of PTSD severity will receive baseline and endpoint maximum load exercise testing which will inform their individualized exercise prescription (based on a progressive methodology) of aerobic exercise. Exercise training is aimed at meeting specific heart rate ranges over time (increasing up to 80% of maximum HRR between the midpoint and endpoint (6-12 weeks).
- interventionNames
- Behavioral: Exercise Testing and Training
Primary outcomes (3)
- measure
- Change From Baseline: PTSD Checklist-5 (PCL-5)
- timeFrame
- Baseline and endpoint (at 13 weeks)
- description
- To be administered at: Endpoint Exercise Test Evaluation Session (week 13). The PCL is a 20-item self-report that assesses the extent to which an individual is bothered by each PTSD symptom during the past month using a 5-point Likert-type scale. The PCL-5 is undergoing validation, but the previous PCL based on DSM-IV had good sensitivity (.82) and specificity (.83). Scoring for each item is on a 0-4 scale with higher scores indicating higher symptom severity. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Initial research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD across samples. However, additional research is needed. Evidence for the PCL for DSM-IV suggests that a 5-10 point change represents reliable change (i.e., change not due to chance) and a 10-20 point change represents clinically significant change.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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 * or have trauma exposure without a diagnosis of PTSD but some symptoms of PTSD, including subthreshold PTSD * other psychiatric conditions * Individuals must meet for current chronic PTSD (\>3 months ) as assessed by the CAPS 1-Month Diagnostic Version. 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. * individuals without PTSD who have had 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.
References
Publications (0)
Data not yet available
No reference posted for this study.