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The Effects of Self Directed Exercise on People With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03400527
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : April 24, 2018
Information provided by (Responsible Party):
AJ Lievre, Shenandoah University

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Self Directed Exercise on People With Fibromyalgia
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exercise
Participant will be pedaling a stationary exercise bicycle
Other: Exercise
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 Measures :
  1. 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

Secondary Outcome Measures :
  1. Change in Numeric Pain Rating Scale [ Time Frame: 0, 4 and 8 weeks ]
    Paint rating scale from 0-10

  2. Change in Short Form (SF) - 36 [ Time Frame: 0, 4 and 8 weeks ]
    Survey of reported health

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03400527

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United States, Virginia
Woodstock Rehab & Fitness Recruiting
Woodstock, Virginia, United States, 22664
Contact: AJ Lievre, DPT    540-665-5522   
Sponsors and Collaborators
Shenandoah University

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Responsible Party: AJ Lievre, Assistant Professor, Shenandoah University Identifier: NCT03400527     History of Changes
Other Study ID Numbers: SUPT 5
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases