Exercise Maintenance in Chronic Pain and PTSD

NCT03644927 | Terminated Results DMC

• 2 other identifiers: H-378241R21AT010293-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain; Posttraumatic Stress Disorder

Keywords

Veterans; Cardiopulmonary exercise testing; Exercise maintenance; Neuropeptide Y (NPY); Exercise-related intrinsic motivation; Exercise Self efficacy; Transtheoretical Model (TTM); Self-Determination Theory (SDT)

Outcome Measures

Primary Outcomes (2)

• Transtheoretical Model of Exercise: Stages of Change (Short-form)

  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.

  Eligibility/screening, baseline, 6 week, and 12 week

• ActiGraph Monitor

  Objective verification of exercise compliance over time

  over the course of 12 weeks of exercise training

Secondary Outcomes (2)

• West Haven Yale Multidimensional Pain Inventory - Pain Interference

  Eligibility/Screening, baseline, 6 week, 12 week

• Clinician-Administered PTSD Scale-5

  Eligibility/screening and 12 week

Other Outcomes (8)

• Self-Efficacy for Exercise

  Eligibility/Screening, baseline, 6 week, 12 week

• Generalized Self-Efficacy Scale

  Eligibility/Screening, baseline, 6 week, 12 week

• Temporal Experience of Pleasure Scale

  Eligibility/Screening, baseline, 6 week, 12 week

Study Arms (2)

Progressive exercise program

EXPERIMENTAL

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

Waitlist Control

ACTIVE COMPARATOR

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

Interventions

Progressive exercise training BEHAVIORAL

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..

Progressive exercise program

Waitlist Control BEHAVIORAL

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.

Waitlist Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• 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).
• 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).
• Psychotropic medications are allowed, as long as the participant has been stable on them for two months.
• 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.
• Using pain medications other than opiates provided none taken for 5 half-lives before CPT/CPX testing, generally about 24 hours.
• Other anxiety or depressive disorders are permitted
• 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
• Can have a mild to moderate TBI, as determined by the BAT-L assessment.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

VA Boston Healthcare System

Jamaica Plain, Massachusetts, 02130, United States

Location

Related Publications (1)

• Scioli ER, Smith BN, Whitworth JW, Spiro A, Esterman M, Dutra S, Bogdan KM, Eld A, Rasmusson AM. Moderated mediation for exercise maintenance in pain and posttraumatic stress disorder: A randomized trial. Health Psychol. 2020 Sep;39(9):826-840. doi: 10.1037/hea0000876.

  PMID: 32833484 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

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 so no data were collected for any of the outcome measures.

Results Point of Contact

• Title: Erica R Scioli, PhD
• Organization: Veterans Administration Boston Healthcare System and BU School of Medicine

ericarose.scioli@va.gov

857 364 6293

Study Officials

• Erica R Scioli, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 23, 2018
• Study Start: January 22, 2019
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)