Chronic Musculoskeletal PainEXCPPTSDNCT03283163
Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD
A study testing Exercise Testing and Training in people with Chronic Musculoskeletal Pain and Posttraumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Musculoskeletal Pain, Posttraumatic Stress Disorder (PTSD), Mild or Moderate Traumatic Brain Injury
- What is being tested?
- Exercise Testing and Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2014to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
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.
Read the detailed description
Due to the COVID-19 pandemic, and after consultation with the appropriate research oversight, all study procedures are temporarily suspended as of 3/15/20.
This study will explicitly examine the effects of a 12-week progressive exercise training program on 1) the clinical symptoms of chronic pain and varying degrees of PTSD symptom severity, 2) anti-stress, anti-nociceptive neurohormones such as allopregnanolone + pregnanolone (ALLO +PA) in Veterans with trauma exposure, chronic pain and varying degrees of PTSD symptom severity. The revised study design includes a baseline 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. Intermittent telephone calls by the PI will provide additional motivational support and assistance with 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" maximum load exercise assessment will occur at week 13 in order to track measurable change for both psychological and neurobiological factors and to delineate their impact on pain indices and PTSD symptomatology. Both maximum load exercise tests will be performed in accordance with guidelines published by the American College of Cardiology. Measures of pain symptomatology will be implemented 30 minutes before and 30 minutes after exercise testing at baseline and endpoint. It is anticipated that differences in biological responses to aerobic and anaerobic exercise as illustrated by variability among the participants, with varying degrees of PTSD symptom severity, will predict differences in the psychological and pain-reducing benefits of aerobic and anaerobic exercise. Once identified, such factors could be augmented by modification of the exercise regimen in order to help enhance the ant-stress hormone levels for the pain/PTSD population and experience clinically significant reductions in their symptoms. In order to obtain sufficient power, the proposed recruitment is 23 participants. Data from this pilot work will be used to compute effect sizes in support of a future clinical trial incorporating individually prescribed exercise regimens and a motivationally based exercise behavior change intervention aimed at reducing pain and PTSD symptoms in our Veterans. Advanced education and training is sought by this CDA-2 award applicant in four broad areas: 1) psychophysiology of chronic pain and PTSD with a sub-focus on sex differences, 2) the neurobiology of chronic stress, PTSD, and pain, 3) exercise physiology and 4) the neuropsychology and neurobiology of traumatic brain injury (TBI). The combination of didactic and experiential training in these areas will serve the PI's long-term goal of becoming an independent scientist/practitioner in the VA focused on development of improved treatments for health conditions co-morbid with PTSD such as chronic pain and mild to moderate TBI. In the shorter-term, this CDA-2 will allow the PI to develop a more effective, motivationally based, exercise behavior change protocol that fosters long-term exercise compliance in patients with trauma-exposure, chronic pain and varying degrees of PTSD symptom severity.. 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 in years 4-5 of the CDA2.
- Conditions
- Chronic Musculoskeletal Pain, Posttraumatic Stress Disorder (PTSD), Mild or Moderate Traumatic Brain Injury
- Being tested
- Exercise Testing and Training
- Medical subject headings
- Stress Disorders, Post-Traumatic, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Testing and TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Pain//PTSD group | Experimental | 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). Receives: Behavioral: Exercise Testing and Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and endpoint (at 13 weeks)
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.
Measured: endpoint (at 13 weeks)
Secondary outcomes (2)
ALLO+PA Resting (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing
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.
Measured: 13 week endpoint Cardiopulmonary Exercise Test Session (MAX-EX)
ALLO+PA Peak (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing
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.
Measured: 13 week endpoint Cardiopulmonary Exercise Test Session (MAX-EX)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start25 Aug 2014
- Primary completion1 Apr 2020
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study includes one group: Trauma-exposed participants suffering from both chronic musculoskeletal pain and varying degrees of PTSD severity. Those who meet diagnostic criteria for Chronic pain and have any symptoms of PTSD will be assigned to that group.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Erica R. Scioli, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283163
- Sponsor's protocol ID
- D0704-W
- Other IDs
- 1k2 RX000704
- Acronym
- EXCPPTSD
- Status last verified
- Jul 2024
- First submitted
- 11 Sep 2017
- Last updated
- 14 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD
- ClinicalTrials.gov ID
- NCT03283163
- Acronym / sponsor ID
- EXCPPTSD / D0704-W
- Conditions
- Chronic Musculoskeletal Pain, Posttraumatic Stress Disorder (PTSD), Mild or Moderate Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 25 Aug 2014 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Due to the COVID-19 pandemic, and after consultation with the appropriate research oversight, all study procedures are temporarily suspended as of 3/15/20.
This study will explicitly examine the effects of a 12-week progressive exercise training program on 1) the clinical symptoms of chronic pain and varying degrees of PTSD symptom severity, 2) anti-stress, anti-nociceptive neurohormones such as allopregnanolone + pregnanolone (ALLO +PA) in Veterans with trauma exposure, chronic pain and varying degrees of PTSD symptom severity. The revised study design includes a baseline 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. Intermittent telephone calls by the PI will provide additional motivational support and assistance with 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" maximum load exercise assessment will occur at week 13 in order to track measurable change for both psychological and neurobiological factors and to delineate their impact on pain indices and PTSD symptomatology. Both maximum load exercise tests will be performed in accordance with guidelines published by the American College of Cardiology. Measures of pain symptomatology will be implemented 30 minutes before and 30 minutes after exercise testing at baseline and endpoint. It is anticipated that differences in biological responses to aerobic and anaerobic exercise as illustrated by variability among the participants, with varying degrees of PTSD symptom severity, will predict differences in the psychological and pain-reducing benefits of aerobic and anaerobic exercise. Once identified, such factors could be augmented by modification of the exercise regimen in order to help enhance the ant-stress hormone levels for the pain/PTSD population and experience clinically significant reductions in their symptoms. In order to obtain sufficient power, the proposed recruitment is 23 participants. Data from this pilot work will be used to compute effect sizes in support of a future clinical trial incorporating individually prescribed exercise regimens and a motivationally based exercise behavior change intervention aimed at reducing pain and PTSD symptoms in our Veterans. Advanced education and training is sought by this CDA-2 award applicant in four broad areas: 1) psychophysiology of chronic pain and PTSD with a sub-focus on sex differences, 2) the neurobiology of chronic stress, PTSD, and pain, 3) exercise physiology and 4) the neuropsychology and neurobiology of traumatic brain injury (TBI). The combination of didactic and experiential training in these areas will serve the PI's long-term goal of becoming an independent scientist/practitioner in the VA focused on development of improved treatments for health conditions co-morbid with PTSD such as chronic pain and mild to moderate TBI. In the shorter-term, this CDA-2 will allow the PI to develop a more effective, motivationally based, exercise behavior change protocol that fosters long-term exercise compliance in patients with trauma-exposure, chronic pain and varying degrees of PTSD symptom severity.. 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 in years 4-5 of the CDA2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study includes one group: Trauma-exposed participants suffering from both chronic musculoskeletal pain and varying degrees of PTSD severity. Those who meet diagnostic criteria for Chronic pain and have any symptoms of PTSD will be assigned to that group.
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain//PTSD group | Experimental | Behavioral: Exercise Testing and TrainingThis 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- Veteran and civilian participants will be excluded from participation in the study if they have:
- 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.:
- Individuals seeking pain treatment such as surgical interventions or who have a neuropathic origin to their pain will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Testing and TrainingThe 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. | Behavioural | Chronic Pain//PTSD group |
Primary outcome
Change From Baseline: PTSD Checklist-5 (PCL-5)
Time frame: 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.
Change From Baseline: West Haven-Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI)
Time frame: 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.
Change From Baseline: Pain Catastrophizing Scale
Time frame: 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.
2 secondary outcomes
ALLO+PA Resting (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing
Time frame: 13 week endpoint Cardiopulmonary Exercise Test Session (MAX-EX)
ALLO+PA Peak (Pre-MAX-EX Testing) Post 12 Weeks of MAX-EX Testing
Time frame: 13 week endpoint Cardiopulmonary Exercise Test Session (MAX-EX)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica R. Scioli, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Testing and Training in people with Chronic Musculoskeletal Pain and Posttraumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline: PTSD Checklist-5 (PCL-5) (time frame: Baseline and endpoint (at 13 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.