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Exercise Maintenance in Chronic Pain and PTSD

TerminatedNot applicableNCT03644927
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Neurobiological Mediators of Self-Regulatory and Reward-Based Motivational Predictors of Exercise Maintenance in Chronic Pain and PTSD
Interventions
  • Behavioral: Progressive exercise training
  • Behavioral: Waitlist Control
Sponsor
Boston University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Start date
2019-01-22
Primary completion
2022-01-06
Sex
All
Age range
from 18 Years to 65 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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. 9. Other anxiety or depressive disorders are permitted 10. 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 11. Can have a mild to moderate TBI, as determined by the BAT-L assessment. 12. Taking medications for chronic psychiatric or medical illnesses is allowed as long as the medications and medication…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03644927