The Effects of Self Directed Exercise on People With Fibromyalgia

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Other: Exercise

• Registration Number: NCT03400527
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-17
• Study Start: 2018-03-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-21
• Last Update Posted: 2018-04-24
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Participant will be pedaling a stationary exercise bicycle

Primary Outcome Measures

Name	Time	Method
Change in Fibromyalgia Impact Questionnaire	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

Name	Time	Method
Change in Numeric Pain Rating Scale	0, 4 and 8 weeks	Paint rating scale from 0-10
Change in Short Form (SF) - 36	0, 4 and 8 weeks	Survey of reported health

Trial Locations

Locations (1)

Woodstock Rehab & Fitness; 🇺🇸 Woodstock, Virginia, United States