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Clinical Trials/NCT03400527
NCT03400527
Unknown
Not Applicable

The Effects of Self Directed Exercise on People With Fibromyalgia

Shenandoah University1 site in 1 country10 target enrollmentMarch 30, 2018
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Shenandoah University
Enrollment
10
Locations
1
Primary Endpoint
Change in Fibromyalgia Impact Questionnaire
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2018
End Date
December 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

AJ Lievre

Assistant Professor

Shenandoah University

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

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Short Form (SF) - 36(0, 4 and 8 weeks)
  • Change in Numeric Pain Rating Scale(0, 4 and 8 weeks)

Study Sites (1)

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