NCT03400527

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

January 8, 2018

Last Update Submit

April 21, 2018

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • 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

    0, 4 and 8 weeks

Secondary Outcomes (2)

  • Change in Numeric Pain Rating Scale

    0, 4 and 8 weeks

  • Change in Short Form (SF) - 36

    0, 4 and 8 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

Participant will be pedaling a stationary exercise bicycle

Other: Exercise

Interventions

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

Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woodstock Rehab & Fitness

Woodstock, Virginia, 22664, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26927193BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 17, 2018

Study Start

March 30, 2018

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

April 24, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)