Reducing Sedentary Time in Fibromyalgia Patients

Fibromyalgia Clinical Trial

— ReSeT-FM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247348
• Other study ID #: 1702201230
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: September 9, 2019

Study information

• Verified date: February 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Veterans

Intervention

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.

Locations

Country	Name	City	State
United States	Roudebush VA Medical Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Richard L. Roudebush VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.