Reducing Sedentary Time in Fibromyalgia Patients

NCT ID: NCT03247348

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2019-09-09

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.

Conditions

Fibromyalgia; Veterans

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

ReSeT-FM intervention

The ReSeT-FM intervention focuses on behavior changes strategies aimed at reducing sedentary time and includes: education, goal setting, self-monitoring of behavior and behavioral prompts to move via an activity tracker and phone app, and feedback on behavior via weekly meetings with study coaches.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Richard L. Roudebush VA Medical Center

FED

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Kelly M Naugle, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelly M Naugle, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Roudebush VA Medical Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1702201230

Identifier Type: -

Identifier Source: org_study_id