Exercise Maintenance in Chronic Pain and PTSD
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|ClinicalTrials.gov Identifier: NCT03644927|
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain Posttraumatic Stress Disorder||Behavioral: Progressive exercise training Behavioral: Waitlist Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neurobiological Mediators of Self-Regulatory and Reward-Based Motivational Predictors of Exercise Maintenance in Chronic Pain and PTSD|
|Actual Study Start Date :||January 22, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||September 2020|
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..
- 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.
- ActiGraph Monitor [ Time Frame: over the course of 12 weeks of exercise training ]Objective verification of exercise compliance over time
- 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."
- 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.
- 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.
- 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).
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
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
|Contact: Erica R Scioli, PhD||857 364 email@example.com|
|Contact: Kristina Bogdan||857 364 6293||Kristina.Bogdan@va.gov|
|United States, Massachusetts|
|VA Boston Healthcare System||Recruiting|
|Jamaica Plain, Massachusetts, United States, 02130|
|Contact: Erica R Scioli, PhD 857-364-5696 firstname.lastname@example.org|
|Principal Investigator:||Erica R Scioli, PhD||Boston University|