NCT03283163|CompletedResults
Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD
EXCPPTSD
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EXCPPTSD
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · VA RR&D
interventional
23
1 country
1
Study Start
August 25, 2014
Actual (reported)Primary Completion
April 1, 2020
Actual (reported)Study Completion
August 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 25, 2014
Actual (reported)September 11, 2017
Actual (reported)September 14, 2017
Actual (reported)April 1, 2020
Actual (reported)August 31, 2022
Actual (reported)August 14, 2024
Actual (reported)Change From Baseline: PTSD Checklist-5 (PCL-5)
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.
Baseline and endpoint (at 13 weeks)
Change From Baseline: West Haven-Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI)
The WHY-MPI has been demonstrated to be applicable across a variety of clinical pain conditions. Its brevity, validity/ reliability, self-report nature and ease of scoring make it ideal for both clinical and research purposes. The WHY-MPI is sensitive to change following rehabilitation. Please note only the interference subscale of the WHY-MPI will be administered in this study. Scoring for each item is on a 0-6 scale; higher scores indicating greater symptom severity. Scoring for this measure includes summing up the items of the scale and dividing by the number of items for that scale to yield an average score of 0-6.
Baseline and endpoint (at 13 weeks)
ALLO+PA Resting (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing
13 week endpoint Cardiopulmonary Exercise Test Session (MAX-EX)
ALLO+PA Peak (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing
13 week endpoint Cardiopulmonary Exercise Test Session (MAX-EX)
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).
The study group will perform a baseline maximum load exercise test which will inform the individualized exercise prescription for the participant. Based on a progressive methodology, the participant will engage in 12 weeks of exercise of their choice (walking, running, cycling or swimming) with the goal of working towards a maximum heart rate range of 80% between weeks 6 and 12 of the study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130, United States
Erica R. Scioli, PhD
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
23 participants (actual enrollment reported by the registry).
First Submitted
September 11, 2017
First Posted
September 14, 2017
Study Start
Group-Based Psychological Treatments Over Video Conference for Older Veterans With Chronic Pain
Change From Baseline: Pain Catastrophizing Scale
The PCS-R is a 13-item measure of which items were drawn from previous experimental and clinical research on catastrophic thinking in relation to pain experience Factor analyses of the PCS have shown that catastrophizing can be viewed as a multidimensional construct comprising elements of rumination ("I can't stop thinking about how much it hurts"), magnification ("I worry that something serious may happen"), and helplessness ("There is nothing I can do to reduce the intensity of the pain"). The factor structure of the PCS has been replicated in several investigations. Scores for each item are on a 0-4 scale with higher scores indicating greater symptom severity, the scores can range from 0-52 and a cutoff of 30 is indicative of a clinically relevant level of catastrophizing.
endpoint (at 13 weeks)
Contact the study team to confirm eligibility.
August 25, 2014
Primary Completion
April 1, 2020
Actual (reported)Study Completion
August 31, 2022
Actual (reported)Last Updated
August 14, 2024
Results First Posted
August 14, 2024
Record last verified: 2024-07
This is a VA single site study. There are no plans to share the data outside of VA Boston Healthcare System, unless specifically requested and approved by authorized officials of VA, once the study has ended. Any data shared will be de-identified and subject to a data use agreement (DUA).
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Source: ClinicalTrials.gov.
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