FibromyalgiaReSeT-FMNCT03247348
Reducing Sedentary Time in Fibromyalgia Patients
An observational study of Fibromyalgia and Veterans, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Veterans
- What is being tested?
- ReSeT-FM intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 9 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinics.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roudebush VA Medical Center
Indianapolis, Indiana, 46202
About this study
Official title: Reducing Sedentary Time in Fibromyalgia (ReSeT-FM): A Feasibility Study
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.
Read the 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
- Being tested
- ReSeT-FM intervention
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReSeT-FM interventionBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minutes of sedentary time per day
Participants will wear an Actigraph accelerometer, which provides a well established measure of sedentary time.
Measured: 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.
Measured: 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 21-item instrument assesses symptoms, function, and overall impact of fibromyalgia.
Measured: This measure will be assessed at baseline and 8 weeks.
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.
Measured: This measure will be assessed at baseline and 8 weeks.
Medical Outcomes Study Short Form Questionnaire (SF-12)
This questionnaire assess physical and mental functioning.
Measured: This measure will be assessed at baseline and 8 weeks.
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.
Measured: This measure will be assessed at baseline and 8 weeks.
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.
Measured: This measure will be assessed at baseline and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start15 Mar 2018
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Richard L. Roudebush VA Medical Center
- Responsible party
- Principal investigator, Kelly M Naugle, PhD, Indiana University
- Investigators
- Kelly M Naugle, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247348
- Sponsor's protocol ID
- 1702201230
- Acronym
- ReSeT-FM
- Status last verified
- Feb 2020
- First submitted
- 1 Aug 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Time in Fibromyalgia (ReSeT-FM): A Feasibility Study
- ClinicalTrials.gov ID
- NCT03247348
- Acronym / sponsor ID
- ReSeT-FM / 1702201230
- Conditions
- Fibromyalgia, Veterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Richard L. Roudebush VA Medical Center
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinics.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReSeT-FM interventionThe 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. | Behavioural | – |
Primary outcome
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.
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.
5 secondary outcomes
Fibromyalgia Impact Questionnaire Revised (FIQ-R)
Time frame: This measure will be assessed at baseline and 8 weeks.
Brief Pain Inventory (BPI)
Time frame: This measure will be assessed at baseline and 8 weeks.
Medical Outcomes Study Short Form Questionnaire (SF-12)
Time frame: This measure will be assessed at baseline and 8 weeks.
Six minute walk test
Time frame: This measure will be assessed at baseline and 8 weeks.
30-second Chair stand test
Time frame: This measure will be assessed at baseline and 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly M Naugle, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Veterans, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.