NCT03247348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

August 1, 2017

Last Update Submit

February 10, 2020

Conditions

FibromyalgiaVeterans

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Fibromyalgia Impact Questionnaire Revised (FIQ-R)

    This measure will be assessed at baseline and 8 weeks.

  • Brief Pain Inventory (BPI)

    This measure will be assessed at baseline and 8 weeks.

  • Medical Outcomes Study Short Form Questionnaire (SF-12)

    This measure will be assessed at baseline and 8 weeks.

  • Six minute walk test

    This measure will be assessed at baseline and 8 weeks.

  • 30-second Chair stand test

    This measure will be assessed at baseline and 8 weeks.

Interventions

ReSeT-FM interventionBEHAVIORAL

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinics.

You may qualify if:

  • Veterans will be eligible if they have:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Kelly M Naugle, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 11, 2017

Study Start

March 15, 2018

Primary Completion

September 9, 2019

Study Completion

September 9, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)