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The Effects of Self Directed Exercise on People With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Shenandoah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Woodstock Rehab & FitnessRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

Participant will be pedaling a stationary exercise bicycle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Numeric Pain Rating Scale
Paint rating scale from 0-10
Change in Short Form (SF) - 36
Survey of reported health

Full Information

First Posted
January 8, 2018
Last Updated
April 21, 2018
Sponsor
Shenandoah University
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1. Study Identification

Unique Protocol Identification Number
NCT03400527
Brief Title
The Effects of Self Directed Exercise on People With Fibromyalgia
Official Title
The Effects of Self Directed Exercise on People With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenandoah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Participant will be pedaling a stationary exercise bicycle
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Fibromyalgia Impact Questionnaire
Description
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
Time Frame
0, 4 and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Numeric Pain Rating Scale
Description
Paint rating scale from 0-10
Time Frame
0, 4 and 8 weeks
Title
Change in Short Form (SF) - 36
Description
Survey of reported health
Time Frame
0, 4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Woodstock Rehab & Fitness
City
Woodstock
State/Province
Virginia
ZIP/Postal Code
22664
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AJ Lievre, DPT
Phone
540-665-5522
Email
alievre@su.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26927193
Citation
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.
Results Reference
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The Effects of Self Directed Exercise on People With Fibromyalgia

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