Reducing Sedentary Time in Fibromyalgia Patients (ReSeT-FM)

Reducing Sedentary Time in Fibromyalgia (ReSeT-FM): A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Veterans
• Intervention / Treatment: Behavioral: ReSeT-FM intervention

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Roudebush VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinics.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in minutes of sedentary time per day	Participants will wear an Actigraph accelerometer, which provides a well established measure of sedentary time.	This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.
Change in minutes of light physical activity per day.	Participants will wear an Actigraph accelerometer, which provides a well established measure of light physical activity.	This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia Impact Questionnaire Revised (FIQ-R)	This 21-item instrument assesses symptoms, function, and overall impact of fibromyalgia.	This measure will be assessed at baseline and 8 weeks.
Brief Pain Inventory (BPI)	This 11-item instrument rates the intensity of pain as well as interference of pain with mood, physical activity, work, social activity, relations with others, sleep, and enjoyment of life.	This measure will be assessed at baseline and 8 weeks.
Medical Outcomes Study Short Form Questionnaire (SF-12)	This questionnaire assess physical and mental functioning.	This measure will be assessed at baseline and 8 weeks.
Six minute walk test	This physical function test measures functional aerobic capacity. Subjects will walk as far as possible at their usual pace in 6 minutes around a predetermined indoor walking course on a flat surface.	This measure will be assessed at baseline and 8 weeks.
30-second Chair stand test	This physical function test measures lower body muscle strength. Subjects will complete as many sit to stands in a chair as possible in 30 seconds.	This measure will be assessed at baseline and 8 weeks.

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Richard L. Roudebush VA Medical Center
• Investigators: Principal Investigator: Kelly M Naugle, PhD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2018
• Primary Completion (ACTUAL): September 9, 2019
• Study Completion (ACTUAL): September 9, 2019

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (ACTUAL): August 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 1702201230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No