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Exercise Maintenance in Chronic Pain and PTSD

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ClinicalTrials.gov Identifier: NCT03644927
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Boston University

Brief Summary:
The primary purpose of the R21 is using an experimental medicine research approach to study whether a chronic, progressive -based exercise program will help Veterans suffering from chronic low back pain (cLBP) and PTSD achieve exercise maintenance, and shared symptom reduction, through neuropeptide Y mediated improvements in putative factors (self-regulation and reward sensitivity) known to improve exercise related self-efficacy and motivation.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Posttraumatic Stress Disorder Behavioral: Progressive exercise training Behavioral: Waitlist Control Not Applicable

Detailed Description:
This study will compare the effects of a 3-month, individually prescribed progressive exercise training program on: 1) chronic low back pain (cLBP), depression and PTSD symptoms, and 2) neurobiological and related neuropsychological mechanisms by which our exercise-training paradigm may foster exercise maintenance. More specifically, the investigators hypothesize relationships between exercise-training associated augmentation of neuropeptide Y (NPY) system function and improved capacities for reward and self-regulation—neuropsychological capacities posited to underlie intrinsic motivation and self-efficacy, which in turn have been shown to predict exercise maintenance. This study will focus on Veterans with cLBP/PTSD. The study design includes a baseline, acute, cardiopulmonary exercise assessment (CPX) that will inform the exercise prescription for the 12-week "progressive exercise" training program, comprised of three 30-45 minute in clinic exercise sessions per week (walking or running--depending on the ability/capacity of the participant). All exercise sessions will be supervised by an exercise physiologist in the Clinical Studies Unit (CSU) at VA Boston Healthcare System. Intermittent telephone calls by the researchers 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). Also, a "midpoint" and "endpoint" CPX assessment will track changes in NPY system function and delineate their impact on pain, depression and PTSD symptoms, as well as the factors proposed to foster exercise maintenance. All three CPX tests will be performed in accordance with guidelines published by the American College of Cardiology. Among Veterans with cLBP/PTSD, the investigators hypothesize that the capacity to release NPY in response to vigorous exercise (i.e., acute CPX testing) will be associated with improvements in pain, depression and PTSD symptoms, as well as the putative factors that predict exercise maintenance. Data from this R21 will be used to demonstrate feasibility and inform the further development of individually prescribed, motivationally based exercise regimens that could be used as adjuncts to cognitive and other therapeutic PTSD, depression or chronic pain interventions to reduce cLBP, depression and PTSD, as well as the negative consequences of these disorders over the long-term.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurobiological Mediators of Self-Regulatory and Reward-Based Motivational Predictors of Exercise Maintenance in Chronic Pain and PTSD
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Progressive exercise program
Based on the "Active Physical Treatment Model" individuals with chronic pain are typically and primarily sedentary or physically deconditioned and need a progressive approach to work up to standard exercise prescriptions as defined by the American College of Sports Medicine. Thus, progressive exercise training can help to minimize the risk or occurrence of a range of exercise-related adverse medical events, particularly with the complex study population which will be starting at a sedentary level and therefore, may not be able to initially achieve the heart rate goals prescribed in standard exercise training protocols. The exercise prescription will be individually designed and geared toward an intensity manageable by the individual..
Behavioral: Progressive exercise training
The 12 week progressive exercise program gradually increases the walking/running intensity and length of exercise every 2 weeks for the first 6 weeks and then maintains the higher intensity level for weeks 7-12,. The exercise intensity is based on percentile targets defined by the baseline cardiopulmonary test (CPX test). Participants will be called at weeks 4 and 10 to assess and foster exercise motivation, using basic principles of motivational interviewing..

Active Comparator: Waitlist Control
The waitlist control participants will be fully screened for eligibility and asked to wait 12 weeks before beginning the 12-week progressive exercise program. They will be assessed again at the end of the 12-week waiting period. These patients will then be compared to patients in the experimental arm and then compared against their own waitlist control data after completing the 12-week exercise program. The exercise program that the waitlist control patients will participate in is identical to the experimental arm.
Behavioral: Waitlist Control
Participants will be screened for eligibility and if randomized into the waitlist control group. Wait list participants will wait for 12-weeks before they can participate in the progressive exercise training program. The 12 week progressive exercise program is identical to the one used in the intervention group. Specifically, the 12 week progressive exercise program gradually increases the walking/running intensity and length of exercise every 2 weeks for the first 6 weeks and then maintains the higher intensity level for weeks 7-12,. The exercise intensity is based on percentile targets defined by the baseline cardiopulmonary test (CPX test). Participants will be called at weeks 4 and 10 to assess and foster exercise motivation, using basic principles of motivational interviewing..




Primary Outcome Measures :
  1. Transtheoretical Model of Exercise: Stages of Change (short-form) [ Time Frame: Eligibility/screening, baseline, 6 week, and 12 week ]
    This 4-item continuous measure categorizes stages of behavioral change based on the Transtheoretical Model (TTM) stages (precontemplation, contemplation, preparation, action and maintenance), specifically in the context of exercise behavior change. Each stage reflects a different level of readiness to exercise, where precontemplation means that the patient is not actively considering exercise behaviors, whereas a patient in the maintenance stage has been actively exercise regularly (3 times per week for 50 minutes minimum) for at least the past 6 months. Scoring for this measure is determined by YES or NO answers provided to questions about exercise behaviors that patients are currently doing or intend to do in the near future. For example, if patients answer YES to the first question "Do you currently engage in regular exercise (at least 3 times per week for 50 or more minutes per session)?", then the patient could either be in the action or maintenance stage of exercise.

  2. ActiGraph Monitor [ Time Frame: over the course of 12 weeks of exercise training ]
    Objective verification of exercise compliance over time


Secondary Outcome Measures :
  1. West Haven Yale Multidimensional Pain Inventory - Pain Interference [ Time Frame: Eligibility/Screening, baseline, 6 week, 12 week ]
    The West Haven Yale Multidimensional Pain Inventory (WHYMPI) has been demonstrated to be applicable across a variety of clinical pain conditions, and this subscale focuses on pain interference. Participants identify a "significant other" defined as a person with whom the participant feels closest to by checking off one of 7 descriptive terms that best represents the relationship with this person and if the participant shares a living space with that person. Next are 20 items about the impact of pain on the participant's life and are scored on a 7-point scale from 0 to 6. Some questions are reverse coded and a higher overall score indicates greater pain interference. Some anchors for 0 to 6 include "No pain/Very intense pain," "No interference/Extreme interference," "No change/Extreme change," "Not at all supportive/Extremely supportive," and "Extremely low mood/Extremely high mood."

  2. Clinician-Administered PTSD Scale-5 [ Time Frame: Eligibility/screening and 12 week ]
    The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make a current (past month) diagnosis of PTSD, lifetime diagnosis of PTD, and assesses PTSD symptoms over the past week. The patient identifies a Criterion A index trauma and the assessor combines information about frequency and intensity of each item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Criterion items are scored 0 to 4 (Absent to Extreme/incapacitating) and summed up. Higher scores indicate greater severity of PTSD.


Other Outcome Measures:
  1. Self-Efficacy for Exercise [ Time Frame: Eligibility/Screening, baseline, 6 week, 12 week ]
    This 6-item scale is used to determine confidence in one's ability to exercise. Total score is calculated by summing the responses to each question. Participants rate self-efficacy to exercise in specific sitguations on 5-point scale from Not at all Confident to Completely Confident. A higher score indicates higher self-efficacy for exercise.

  2. Generalized Self-Efficacy Scale [ Time Frame: Eligibility/Screening, baseline, 6 week, 12 week ]
    This revised10-item scale taps into a global sense of self-efficacy, or belief by an individual in his or her ability (e.g., "I can always solve difficult problems if I try hard enough, " and "I can usually handle whatever comes 66-68 This 10-item self-report scale assesses habitual use of two common strategies to alter emotion captured on two sub-scales: cognitive reappraisal and expressive suppression. Items are rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree).

  3. Temporal Experience of Pleasure Scale [ Time Frame: Eligibility/Screening, baseline, 6 week, 12 week ]
    This 18-item self-report measure uses a Likert-like scale (1-6) to assess reward sensitivity to specific experiences that are either anticipatory (the night before a major holiday) or consummatory (chocolate chip cookie). Participants rate from 1 (very false for me) to 6 (very true for me) when presented statements about how one might react to specific rewarding stimuli. Scores are added together and greater score represent higher anticipation of a reward, higher enjoyment when presented a tangible reward, a greater total score (subscales added) represents a higher sensitivity to rewarding stimuli.

  4. Effort Expenditure for Rewards Task [ Time Frame: Eligibility/Screening, baseline, 6 week, 12 week ]
    This computerized (Matlab) task (for which scripts have been obtained from the developer for study use) captures willingness to expend effort for rewards. EEfRT scores have been inversely related to anhedonia. The task has been validated in healthy college students and adults with major depression and schizophrenia.

  5. Neuropeptide-Y [ Time Frame: Baseline, 6 week, 12 week ]
    The blood plasma will be collected in EDTA tubes and placed immediately on wet ice; it will be spun within 20 minutes of collection at 3000 rpm for 15 minutes in a refrigerated centrifuge before aliquoting into tubes for storage at -70 degrees C until assays of the neurosteroids/peptides of interest are performed. Plasma NPY will be measured by radioimmunoassy (RIA) as previously described (Rasmusson et al., 2000).

  6. Go/No-Go Task [ Time Frame: Baseline, 6 week, 12 week ]
    This computerized task measures response inhibition. Participants are asked to respond to certain ("go") stimuli and make no response "no-go" stimuli, while maintaining speed and accuracy The main dependent measure is the commission error rate making a "go" response to "no-go" trials.

  7. Exercise Motivation Scale [ Time Frame: Eligibility/Screening, baseline, 6 week, 12 week ]
    This 31-item scale is used to determine extrinsic and intrinsic variants of exercise motivation based on Self-Determination Theory. Participants rate statements about personal motivation from 1 (strongly disagree) to 6 (strongly agree), depending on how strongly the participant relates to each item. Higher scores on specific items reflect the major sources of the participant's motivation to exercise. For example, higher scores on items 2, 10, 15, and 27 indicates intrinsic motivation to learn more about/from exercising.

  8. Beck Depression Inventory [ Time Frame: Eligibility/Screening, baseline, 6 week, 12 week ]
    The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item self-report measure of depressive symptom severity. It yields a total score and subscale scores for depressive cognitive and somatic symptoms. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is calculated by adding the sums of both subscales, with 0-13 indicating minimal depression, 14-19 indicating mild depression, 20-28 indicating moderate depression, and 29-63 indicating severe depression.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ICD-9 or ICD-10 diagnosis of chronic low back pain, as confirmed by the rehabilitation medicine doctor consulting to the study, and a confirmed comorbid psychiatric diagnosis of PTSD. More specifically, the CLBP/PTSD participant must meet for current chronic PTSD (>3 months) as assessed by the CAPS-5, 1-Month Diagnostic Version.
  2. A medical history, physical examination, vital signs, EKG, and baseline laboratory studies, including urine toxicology screens and a negative urine pregnancy test (woman only), indicate that symptom-limited cardiopulmonary exercise stress (CPX) testing will be safe.
  3. Women of child bearing capacity must agree to use effective contraception while participating; a urine pregnancy test performed on the morning prior to completing CPX testing will also be done.
  4. Relatively sedentary at enrollment, as defined by the American College of Sports Medicine (i.e., performing less than 30 minutes/day and less than 150 minutes per week of moderate physical activity).
  5. Free of medications and other substances (e.g., illicit drugs and alcohol) with effects that could hinder data interpretation for 2-6 weeks before the cold pressor test (CPT) and CPX testing depending on the medication and frequency of use (which must be cleared by the study Co-I and study MD, Dr. Rasmusson).
  6. Psychotropic medications are allowed, as long as the participant has been stable on them for two months.
  7. Tobacco product use is allowed; participants will not be required to lower or stop their dosage/intake; intensity of smoking will be monitored across the study via use of urine testing for cotinine (a long-lived metabolite of nicotine) at each test session. Regular morning nicotine users will be instructed to smoke/chew to satisfaction just prior to arriving at the Clinical Studies Unit for testing, which will be approximately 2-3 hours prior to performance of the CPT and CPX.
  8. Using pain medications other than opiates provided none taken for 5 half-lives before CPT/CPX testing, generally about 24 hours.

10. Other anxiety or depressive disorders are permitted 11. May be involved in supportive psychotherapies as long as their participation has been stable for 3 months prior to study entry and remains stable throughout the course of the study 12. Can have a mild to moderate TBI, as determined by the BAT-L assessment. 13. Taking medications for chronic psychiatric or medical illnesses is allowed as long as the medications and medication dosing are stable for two months prior to participation in the study and remain stable throughout the 12 week exercise training protocol and final exercise test.

Exclusion Criteria:

  1. A life threatening or acute physical illness (e.g., cancer), current schizophreniform illnesses, bipolar disorder, or active suicidal or homicidal ideation requiring clinical intervention.
  2. Current or past alcohol and/or substance dependence (less than three months from date of screening assessment)
  3. Current opiate pain medication use
  4. Women who are or are planning to become pregnant within the next six months
  5. Individuals seeking pain treatment such as surgical interventions or who have a neuropathic origin to their pain
  6. Cannot tolerate exercising on a treadmill or on an upright bike due to chronic pain
  7. 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) and more than first degree atrioventricular block
  8. Severe TBI, as evidenced on the VA TBI screen and the BAT-L assessment.

Information from the National Library of Medicine

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): NCT03644927


Contacts
Contact: Erica R Scioli, PhD 857 364 6293 ericarose.scioli@va.gov
Contact: Kristina Bogdan 857 364 6293 Kristina.Bogdan@va.gov

Locations
United States, Massachusetts
VA Boston Healthcare System Not yet recruiting
Jamaica Plain, Massachusetts, United States, 02130
Contact: Erica R Scioli, PhD    857-364-5696    ericarose.scioli@va.gov   
Sponsors and Collaborators
Boston University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Erica R Scioli, PhD Boston University

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT03644927     History of Changes
Other Study ID Numbers: H-37824
1R21AT010293-01 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston University:
Veterans
Cardiopulmonary exercise testing
Exercise maintenance
Neuropeptide Y (NPY)
Exercise-related intrinsic motivation
Exercise Self efficacy
Transtheoretical Model (TTM)
Self-Determination Theory (SDT)

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Stress Disorders, Post-Traumatic
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders