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Trial record 10 of 111 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

The Effects of Self Directed Exercise on People With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03400527
Recruitment Status : Not yet recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Fibromyalgia Other: Exercise

Study Design

Study Type : Interventional
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
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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

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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases