Neurohormonal Benefits of Exercise in Fibromyalgia and PTSD

NCT03236467 | Completed

• 2 other identifiers: D2395-P1I21RX002395-01A1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The most recent conflicts are creating a new generation of Veterans, including an increasing number of women Veterans, who present with comorbid PTSD and chronic pain conditions, including Fibromyalgia (FM), from deployment-related physical injuries and exposure to psychological trauma. Health behavior change is important in treating these conditions and proactively preventing long-term negative health sequelae, in order to benefit these Veterans directly and reduce the challenges to our healthcare system. The proposed SPiRE application will use an innovative translational research approach to study whether a progressive -based exercise program will reduce FM pain in patients with PTSD and to elucidate and modify potential PTSD-related deficiencies in neurobiological and psychological responses to exercise to optimize the physical and psychological benefits of exercise for these individuals.

Conditions

FM and PTSD

Keywords

Fibromyalgia and PTSD

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire-Revised

  The FIQR has been found to be a useful and brief instrument to assess the overall impact and severity of FM. The FIQR consists of 21-items that assess pain, fatigue, stiffness, sleep, depression, memory, anxiety, balance, and environment sensitivity. All items are framed in the past 7 days and are scored on an 11-point numeric rating scores of 0 to 10. The total score ranges from 0 to 100, with higher scores representing greater symptom burden and functional limitations.

  Two Years

Secondary Outcomes (1)

• Clinician Administered PTSD Scale -5

  Two Years

Study Arms (1)

FM + PTSD

EXPERIMENTAL

Individuals suffering from Fibromyalgia and PTSD

Behavioral: Progressive Exercise Training

Interventions

Progressive Exercise Training BEHAVIORAL

Designed to ease primarily sedentary individuals into exercise training, increasing in intensity up to 80% of maximum Heart Rate Range over time.

FM + PTSD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Only Veteran and civilian participants in whom a physical examination and medical history indicate that the participant meets current diagnostic criteria for FM, as specified by the American College of Rheumatology, will be eligible for the study.
• Eligible participants who agree to a blood draw for measurement of biomarkers, must be free of medications and other substances (e.g., illicit drugs and alcohol) that may alter results for 2-6 weeks depending on the medication and frequency of use (which must be cleared by MD consultants).
• If on pain medications with short half-lives, participants must be off of them for 5 half-lives before testing, generally about 24 hours.
• Any participant with a confirmed psychiatric diagnosis of PTSD will be included in the study. Individuals in the PTSD group must meet diagnostic criteria for current chronic PTSD (\>3 months) as assessed by the CAPS-5, 1-Month Diagnostic Version.

You may not qualify if:

• Participants will be excluded from participation in the study if they have a life threatening or acute physical illness (e.g., cancer)
• Current schizophreniform illnesses (except for Psychosis NOS due to PTSD-related sensory hallucinations)
• Untreated bipolar disorder
• Or active suicidal or homicidal ideation requiring clinical intervention
• Individuals with current or past alcohol and/or substance dependence (less than three months from date of screening assessment) will be excluded
• Individuals seeking interventional pain treatment, such as surgical interventions or other pain clinic interventions, will also be excluded unless they agree to participate in the biomarker procedure prior to the start of their pain intervention.
• Finally, participants who have a neuropathic origin to their pain will be excluded.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Boston Healthcare System: collaborator

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Fibromyalgia

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Erica R. Scioli, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Using an innovative translational research approach to study whether a 12 week-progressive - exercise program will reduce FM pain in patients with PTSD and to elucidate and modify potential PTSD-related deficiencies in neurobiological and psychological responses to exercise

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 2, 2017
• Study Start: January 1, 2018
• Primary Completion: April 29, 2022
• Study Completion: August 31, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)