FibromyalgiaNCT03400527
The Effects of Self Directed Exercise on People With Fibromyalgia
A study testing Exercise in people with Fibromyalgia, run by Shenandoah University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of self directed exercise on pain and function reported in patients with Fibromyalgia both in the short term and long term. Previous studies have shown that patients with fibromyalgia respond better to a single session of self directed exercise compared to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2018to Dec 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of 18
- a medical diagnosis of Fibromyalgia
- sedentary level of activity prior to entry. Sedentary level of activity is defined as: no participation in regular physical activity more strenuous than slow paced walking for a maximum of 2 times per week for the 4 months prior to study entry.
- signed release from their physician stating that they are able to participate in the study.
Who cannot join
- presence of an acute or chronic medical condition such as cancer
- infection, cardiovascular or respiratory disease (that would limit their exercise participation), metabolic or musculoskeletal or neurologic condition (systemic lupus or rheumatoid arthritis, or other pain disorders)
- already participating or plan on participating in a regular aerobic exercise program 6 months prior to the study
- ongoing or planned Physical Therapy treatment
- drug dependency
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Woodstock Rehab & Fitness
Woodstock, Virginia, 22664
AJ Lievre, DPT, 540-665-5522, alievre@su.edu
About this study
The purpose of this study is to determine the effects of self directed exercise on pain and function reported in patients with Fibromyalgia both in the short term and long term. Previous studies have shown that patients with fibromyalgia respond better to a single session of self directed exercise compared to prescriptive exercise. To the investigator's knowledge, no studies have examined the impact on pain and function after multiple sessions of self directed exercise in this patient population.
This study hoes to be a case series exploring the effects of self directed exercise on participants with fibromyalgia. Participants will be encouraged to exercise 8-12 times in a 4 week time frame at a self selected pace and intensity on a stationary bicycle. Outcome measures such as the Fibromyalgia Impact Questionnaire, SF-36 and Numeric Pain Rating Scale will be used prior to study participation as well as 4 and 8 weeks following the start of participation.
- Conditions
- Fibromyalgia
- Being tested
- Exercise
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants will pedal on a stationary bicycle up to 25 minutes 2-3 times a week for 4 weeks at a self directed pace and intensity
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participant will be pedaling a stationary exercise bicycle Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fibromyalgia Impact Questionnaire
An instrument developed to assess the current health status of women with the fibromyalgia syndrome in clinical and research settings1.
Assesses current health and functional status in people with Fibromyalgia
Measured: 0, 4 and 8 weeks
Secondary outcomes (2)
Change in Numeric Pain Rating Scale
Paint rating scale from 0-10
Measured: 0, 4 and 8 weeks
Change in Short Form (SF) - 36
Survey of reported health
Measured: 0, 4 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 posted17 Jan 2018
- Study start30 Mar 2018
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenandoah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AJ Lievre, Shenandoah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400527
- Sponsor's protocol ID
- SUPT 5
- Status last verified
- Apr 2018
- First submitted
- 8 Jan 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ellingson LD, Stegner AJ, Schwabacher IJ, Koltyn KF, Cook DB. Exercise Strengthens Central Nervous System Modulation of Pain in Fibromyalgia. Brain Sci. 2016 Feb 26;6(1):8. doi: 10.3390/brainsci6010008.
PubMed 26927193
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Self Directed Exercise on People With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03400527
- Acronym / sponsor ID
- SUPT 5
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shenandoah UniversityUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Jan 2018 (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.
The purpose of this study is to determine the effects of self directed exercise on pain and function reported in patients with Fibromyalgia both in the short term and long term. Previous studies have shown that patients with fibromyalgia respond better to a single session of self directed exercise compared to prescriptive exercise. To the investigator's knowledge, no studies have examined the impact on pain and function after multiple sessions of self directed exercise in this patient population.
This study hoes to be a case series exploring the effects of self directed exercise on participants with fibromyalgia. Participants will be encouraged to exercise 8-12 times in a 4 week time frame at a self selected pace and intensity on a stationary bicycle. Outcome measures such as the Fibromyalgia Impact Questionnaire, SF-36 and Numeric Pain Rating Scale will be used prior to study participation as well as 4 and 8 weeks following the start of participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseParticipant will be pedaling a stationary exercise bicycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over the age of 18
- a medical diagnosis of Fibromyalgia
- sedentary level of activity prior to entry. Sedentary level of activity is defined as: no participation in regular physical activity more strenuous than slow paced walking for a maximum of 2 times per week for the 4 months prior to study entry.
- signed release from their physician stating that they are able to participate in the study.
Key exclusion criteria (5 listed)
- presence of an acute or chronic medical condition such as cancer
- infection, cardiovascular or respiratory disease (that would limit their exercise participation), metabolic or musculoskeletal or neurologic condition (systemic lupus or rheumatoid arthritis, or other pain disorders)
- already participating or plan on participating in a regular aerobic exercise program 6 months prior to the study
- ongoing or planned Physical Therapy treatment
- drug dependency
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 |
|---|---|---|
| ExerciseParticipants will pedal on a stationary bicycle up to 25 minutes 2-3 times a week for 4 weeks at a self directed pace and intensity | Other | Exercise |
Primary outcome
Change in Fibromyalgia Impact Questionnaire
Time frame: 0, 4 and 8 weeks
An instrument developed to assess the current health status of women with the fibromyalgia syndrome in clinical and research settings1. Assesses current health and functional status in people with Fibromyalgia
2 secondary outcomes
Change in Numeric Pain Rating Scale
Time frame: 0, 4 and 8 weeks
Change in Short Form (SF) - 36
Time frame: 0, 4 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Background: PubMed 26927193Ellingson LD, Stegner AJ, Schwabacher IJ, Koltyn KF, Cook DB. Exercise Strengthens Central Nervous System Modulation of Pain in Fibromyalgia. Brain Sci. 2016 Feb 26;6(1):8. doi: 10.3390/brainsci6010008.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Fibromyalgia, run by Shenandoah 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fibromyalgia Impact Questionnaire (time frame: 0, 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400527, which also lists 1 linked publication.
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 24 Apr 2018.