Trial Outcomes & Findings for Exercise Maintenance in Chronic Pain and PTSD (NCT NCT03644927)
NCT ID: NCT03644927
Last Updated: 2023-01-25
Results Overview
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.
TERMINATED
NA
11 participants
Eligibility/screening, baseline, 6 week, and 12 week
2023-01-25
Participant Flow
92 potential participants were identified. 37.4% (n=34/92) were determined to be ineligible, 7.7% were loss to follow-up prior to signing consent, 3.2% had unknown status, 34.7% were in the process of being scheduled for their screening, 20.9% (n=19) had a screening visit scheduled and 11 of those were screened and provided signed consent.
Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
Participant milestones
| Measure |
Progressive Exercise Program
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.
|
Waitlist Control
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Progressive Exercise Program
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.
|
Waitlist Control
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.
|
|---|---|---|
|
Overall Study
The single subject in this arm didn't complete the 12 weeks intervention before study termination.
|
1
|
0
|
Baseline Characteristics
Exercise Maintenance in Chronic Pain and PTSD
Baseline characteristics by cohort
| Measure |
All Participants
n=11 Participants
All enrolled participants are aggregated into one group since only one participant was randomized into one of the 2 study arms prior to termination of the study.
|
|---|---|
|
Age, Continuous
|
48.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispaic
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Eligibility/screening, baseline, 6 week, and 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: over the course of 12 weeks of exercise trainingPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
Objective verification of exercise compliance over time
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Eligibility/Screening, baseline, 6 week, 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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."
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Eligibility/screening and 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eligibility/Screening, baseline, 6 week, 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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 situations on 5-point scale from Not at all Confident to Completely Confident. A higher score indicates higher self-efficacy for exercise.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eligibility/Screening, baseline, 6 week, 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eligibility/Screening, baseline, 6 week, 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eligibility/Screening, baseline, 6 week, 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 week, 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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 radioimmunoassay (RIA) as previously described (Rasmusson et al., 2000).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 week, 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eligibility/Screening, baseline, 6 week, 12 weekPopulation: The study was terminated prior to randomization into the study arms and no participant received any intervention.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eligibility/Screening, baseline, 6 week, 12 weekPopulation: Only one of the 11 consented participants was randomized into a study arm, the other 10 were not randomized prior to study termination. The 'progressive exercise' arm participant only completed 6 of the 12 weeks intervention before the study was terminated nut did not provide any outcome measure data and due to concerns over confidentiality no baseline data for that one participant will be reported.
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.
Outcome measures
Outcome data not reported
Adverse Events
Progressive Exercise Program
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Progressive Exercise Program
n=11 participants at risk
Only one participant was randomized into this study arm prior to study termination and they only completed half \[6 out of the 12 week\] of the study intervention prior to study termination.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • Adverse events were collected for the 6 weeks that one participant received the study intervention prior to study termination. In addition prior to randomization two participants had an adverse event during the rigorous and conservative screening process and they were not allowed to proceed to the intervention. One participant felt nauseous and had a headache and the other had abnormal EKG findings and a positive history for cardiac issues.
|
|
General disorders
Headache
|
9.1%
1/11 • Number of events 1 • Adverse events were collected for the 6 weeks that one participant received the study intervention prior to study termination. In addition prior to randomization two participants had an adverse event during the rigorous and conservative screening process and they were not allowed to proceed to the intervention. One participant felt nauseous and had a headache and the other had abnormal EKG findings and a positive history for cardiac issues.
|
|
Cardiac disorders
Cardiac abnormalities
|
9.1%
1/11 • Number of events 1 • Adverse events were collected for the 6 weeks that one participant received the study intervention prior to study termination. In addition prior to randomization two participants had an adverse event during the rigorous and conservative screening process and they were not allowed to proceed to the intervention. One participant felt nauseous and had a headache and the other had abnormal EKG findings and a positive history for cardiac issues.
|
Additional Information
Erica R Scioli, PhD
Veterans Administration Boston Healthcare System and BU School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place