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Reducing Sedentary Time in Fibromyalgia Patients (ReSeT-FM)

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ClinicalTrials.gov Identifier: NCT03247348
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Richard L. Roudebush VA Medical Center
Information provided by (Responsible Party):
Kelly M Naugle, PhD, Indiana University

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.

Condition or disease Intervention/treatment
Fibromyalgia Veterans 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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reducing Sedentary Time in Fibromyalgia (ReSeT-FM): A Feasibility Study
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinics.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247348


Contacts
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Contact: Kelly M Naugle, PhD 317-274-0601 kmnaugle@iupui.edu

Locations
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United States, Indiana
Roudebush VA Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kelly M Naugle, PhD    317-274-0601    kmnaugle@iupui.edu   
Sponsors and Collaborators
Indiana University
Richard L. Roudebush VA Medical Center
Investigators
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Principal Investigator: Kelly M Naugle, PhD Indiana University School of Medicine

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Responsible Party: Kelly M Naugle, PhD, Assistant Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03247348     History of Changes
Other Study ID Numbers: 1702201230
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases