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Completed

NCT Number: NCT03247348

Reducing Sedentary Time in Fibromyalgia Patients

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Veterans

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReSeT-FM intervention

Behavioral

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.

Primary outcomes

  1. Change in minutes of sedentary time per day

    Time frame: This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.

    Participants will wear an Actigraph accelerometer, which provides a well established measure of sedentary time.

  2. Change in minutes of light physical activity per day.

    Time frame: This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.

    Participants will wear an Actigraph accelerometer, which provides a well established measure of light physical activity.

Secondary outcomes

  1. Fibromyalgia Impact Questionnaire Revised (FIQ-R)

    Time frame: This measure will be assessed at baseline and 8 weeks.

    This 21-item instrument assesses symptoms, function, and overall impact of fibromyalgia.

  2. Brief Pain Inventory (BPI)

    Time frame: This measure will be assessed at baseline and 8 weeks.

    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.

  3. Medical Outcomes Study Short Form Questionnaire (SF-12)

    Time frame: This measure will be assessed at baseline and 8 weeks.

    This questionnaire assess physical and mental functioning.

  4. Six minute walk test

    Time frame: This measure will be assessed at baseline and 8 weeks.

    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.

  5. 30-second Chair stand test

    Time frame: This measure will be assessed at baseline and 8 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Richard L. Roudebush VA Medical Center

Registry information

Official study title

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

Acronym: ReSeT-FM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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