Trial Outcomes & Findings for Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD (NCT NCT03283163)
NCT ID: NCT03283163
Last Updated: 2024-08-14
Results Overview
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.
COMPLETED
NA
23 participants
Baseline and endpoint (at 13 weeks)
2024-08-14
Participant Flow
Recruitment took place from 8/25/2014-3/20/2020 at the VA Boston Healthcare System, Women's Health Sciences Division (WHSD), National Center for PTSD (NCPTSD). Participants were receiving care in the VA Boston Healthcare System (VABHS) or recruited from the community. Inclusion criteria for the proposed study will permit the recruitment of women as well as men from all ethnic and racial backgrounds who are at least 18 years of age, and able to speak and understand English.
Participant milestones
| Measure |
Chronic Pain/PTSD Group
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).
Exercise Testing and Training: 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.
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|---|---|
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Overall Study
STARTED
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23
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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11
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Reasons for withdrawal
| Measure |
Chronic Pain/PTSD Group
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).
Exercise Testing and Training: 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.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Overall Study
other life commitments
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6
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Overall Study
COVID-19 institution wide halting
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1
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Overall Study
Participants tested positive for illicit drugs on the day of the testing and/or training procedures
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2
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Overall Study
Participant found to not be forthcoming with screening/baseline assessments
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1
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Baseline Characteristics
Two participants were found to test positive for illicit substances and one was found to not be forthcoming during assessments so they were excluded from the final analyses due to measurement of neurohormone data.
Baseline characteristics by cohort
| Measure |
Chronic Pain//PTSD Group
n=23 Participants
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).
Exercise Testing and Training: 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.
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Age, Continuous
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44.96 years
STANDARD_DEVIATION 9.17 • n=23 Participants
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Sex: Female, Male
Female
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8 Participants
n=23 Participants
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Sex: Female, Male
Male
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15 Participants
n=23 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=23 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=23 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=23 Participants
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Race (NIH/OMB)
Black or African American
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12 Participants
n=23 Participants
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Race (NIH/OMB)
White
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7 Participants
n=23 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=23 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=23 Participants
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Region of Enrollment
United States
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23 Participants
n=23 Participants
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West Haven Yale Multidimensional Pain Inventory (WHYMPI)
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2.85 units on a scale
STANDARD_DEVIATION 1.67 • n=20 Participants • Two participants were found to test positive for illicit substances and one was found to not be forthcoming during assessments so they were excluded from the final analyses due to measurement of neurohormone data.
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Posttraumatic Stress Disorder Checklist-5 (PCL-5)
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26.21 units on a scale
STANDARD_DEVIATION 14.32 • n=19 Participants • Two participants were found to test positive for illicit substances and one was found to not be forthcoming with assessments and one participant had missing data so they were excluded from the final analyses due to measurement of neurohormone data. Some missing data for one participant was also observed.
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Pain Catastrophizing Scale
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21.35 units on a scale
STANDARD_DEVIATION 14.28 • n=20 Participants • Two participants were found to test positive for illicit substances and one participant was found to not be forthcoming with assessments and were therefore excluded from the final analyses due to measurement of neurohormone data.
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ALLO +PA at rest (Pre MAX-EX testing)
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3532.53 pg/ml
STANDARD_DEVIATION 5042.86 • n=17 Participants • While we had 23 participants at baseline; 2 participants tested positive for illicit substances, 1 participant was excluded due to not being forthcoming with assessments, 2 participants did not have chronic pain and 1 participant's assay results were not detectable at this time for which we are awaiting updated assay results. This resulted in a sample of n=17 for the analysis.
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ALLO+PA at peak (30 minutes post MAX-EX testing)
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6175.29 pg/ml
STANDARD_DEVIATION 16670.62 • n=17 Participants • While we had 23 participants at baseline; 2 participants tested positive for illicit substances, 1 participant was excluded due to not being forthcoming with assessment, 2 participants did not have chronic pain and 1 participant's assay results were not detectable at this time, for which we are awaiting updated assay results. This resulted in a sample of n=17 for the analysis.
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PRIMARY outcome
Timeframe: Baseline and endpoint (at 13 weeks)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.
Outcome measures
| Measure |
Chronic Pain//PTSD Group
n=11 Participants
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).
Exercise Testing and Training: 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.
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Change From Baseline: PTSD Checklist-5 (PCL-5)
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15.64 units on a scale
Standard Deviation 11.34
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PRIMARY outcome
Timeframe: Baseline and endpoint (at 13 weeks)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.
Outcome measures
| Measure |
Chronic Pain//PTSD Group
n=12 Participants
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).
Exercise Testing and Training: 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.
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|---|---|
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Change From Baseline: West Haven-Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI)
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2.56 units on a scale
Standard Deviation 1.63
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PRIMARY outcome
Timeframe: endpoint (at 13 weeks)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.
Outcome measures
| Measure |
Chronic Pain//PTSD Group
n=12 Participants
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).
Exercise Testing and Training: 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.
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|---|---|
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Change From Baseline: Pain Catastrophizing Scale
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13.92 units on a scale
Standard Deviation 12.06
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SECONDARY outcome
Timeframe: 13 week endpoint Cardiopulmonary Exercise Test Session (MAX-EX)Population: Trauma exposed participants with chronic musculoskeletal pain and varying degrees of PTSD symptom severity.
ALLO+PA are anti-stress and antinociceptive neurosteroids that were measured in plasma at rest and peak (before and after a baseline and endpoint cardiopulmonary exercise test). Higher scores reflect greater levels of the anti-stress, antinociceptive neurohormone, indicating a better outcome.
Outcome measures
| Measure |
Chronic Pain//PTSD Group
n=12 Participants
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).
Exercise Testing and Training: 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.
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|---|---|
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ALLO+PA Resting (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing
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5855.33 pg/ml
Standard Deviation 6542.71
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SECONDARY outcome
Timeframe: 13 week endpoint Cardiopulmonary Exercise Test Session (MAX-EX)Population: Trauma exposed participants with chronic musculoskeletal pain and varying degrees of PTSD symptom severity.
ALLO+PA are anti-stress and antinociceptive neurosteroids that were measured in plasma at rest and peak (before and after a baseline and endpoint cardiopulmonary exercise test). Higher scores reflect greater levels of the anti-stress, antinociceptive neurohormone, indicating a better outcome.
Outcome measures
| Measure |
Chronic Pain//PTSD Group
n=12 Participants
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).
Exercise Testing and Training: 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.
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|---|---|
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ALLO+PA Peak (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing
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4062.50 pg/ml
Standard Deviation 5971.54
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Adverse Events
Chronic Pain/PTSD Group
Serious adverse events
| Measure |
Chronic Pain/PTSD Group
n=23 participants at risk
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).
Exercise Testing and Training: 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.
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|---|---|
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Cardiac disorders
1mm ST segment Depression on ECG during Exercise Test
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4.3%
1/23 • Number of events 1 • Adverse event data were collected throughout the entire period of active recruitment for each participant (i.e., from the date of study entry through the follow-up, yielding a total of 8 months.
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Other adverse events
| Measure |
Chronic Pain/PTSD Group
n=23 participants at risk
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).
Exercise Testing and Training: 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.
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|---|---|
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Musculoskeletal and connective tissue disorders
Leg pain during exercise training phase of the study based on prior injury
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4.3%
1/23 • Number of events 1 • Adverse event data were collected throughout the entire period of active recruitment for each participant (i.e., from the date of study entry through the follow-up, yielding a total of 8 months.
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Additional Information
Erica R. Checko (Scioli), PhD
VA Boston Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place