Clinical trial NCT03247348: Reducing Sedentary Time in Fibromyalgia Patients
Official title: Reducing Sedentary Time in Fibromyalgia (ReSeT-FM): A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Veterans
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Richard L. Roudebush VA Medical Center
First posted: 2017-08-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinics.

Brief summary: This study evaluates the feasibility of a behavioral intervention designed to replace sedentary behavior with light physical activity in veterans with Fibromyalgia. The study will also evaluate the acceptability of the intervention among veterans and intervention effects on pain and physical function.

Detailed description: Recent research suggests that individuals with Fibromyalgia (FM) who spend more time in sedentary behavior and less time in light physical activity experience greater clinical pain and overall impact of FM, irrespective of time spent in moderate to vigorous physical activity. To date, no studies have investigated the potential impact of reducing sedentary behavior on key clinical and physical function outcomes in FM. The overall objective of the pilot project is to design and evaluate the feasibility of an 8-week behavioral intervention designed to replace sedentary behavior with light physical activity in veterans with FM. Mixed (quantitative and qualitative) methods will be used to evaluate the behavioral intervention, which is based on constructs from social cognitive and self-regulatory theories that consistently identify important drivers of behavior change as: education, goal-setting, self-monitoring and behavioral prompts to move via an activity tracker and phone app, and feedback on behavior via weekly meetings.

Eligibility criteria: Inclusion Criteria:

Veterans will be eligible if they have:

* 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia: Widespread Pain Index (WPI) greater than 7 and Symptom Severity Scale (SS) greater than 5 or WPI 3-6 and SS greater than 9.
* Symptoms have been present at a similar level for at least 3 months
* The subject does not have a disorder that would otherwise explain the pain
* Moderate pain severity (pain severity score greater than 5)
* No changes in fibromyalgia medications for last 4 weeks
* Self-reporting at least 8 hours per day sitting on 5 or more days per week
* Having access to either an Android or iPhone smart phone with access to internet

Exclusion Criteria:

* Significant cardiovascular disease
* chronic obstructive pulmonary disease (COPD) or asthma needing home oxygen
* Stroke or transient ischemic attack (TIA) in last 6 months
* Cancer (other than skin cancer) and receiving treatment for it
* Active psychosis
* Active suicidal ideation
* Moderate to severe cognitive impairment
* Engaging in more than 30 minutes of moderate to vigorous physical activity 3 or more days per week
* Currently using an app or activity tracker to track physical activity
* Enrolled in another research study related to pain or exercise

Primary outcomes:
measure: Change in minutes of sedentary time per day
timeFrame: This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.
measure: Change in minutes of light physical activity per day.
timeFrame: This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire Revised (FIQ-R)
timeFrame: This measure will be assessed at baseline and 8 weeks.
measure: Brief Pain Inventory (BPI)
timeFrame: This measure will be assessed at baseline and 8 weeks.
measure: Medical Outcomes Study Short Form Questionnaire (SF-12)
timeFrame: This measure will be assessed at baseline and 8 weeks.
measure: Six minute walk test
timeFrame: This measure will be assessed at baseline and 8 weeks.
measure: 30-second Chair stand test
timeFrame: This measure will be assessed at baseline and 8 weeks.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Roudebush VA Medical Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Kelly M Naugle, PhD
role: PRINCIPAL_INVESTIGATOR
References: