The Effects of Self Directed Exercise on People With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

The Effects of Self Directed Exercise on People With Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400527
• Other study ID #: SUPT 5
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2018
• Last updated: April 21, 2018
• Start date: March 30, 2018
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: Shenandoah University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	Woodstock Rehab & Fitness	Woodstock	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Shenandoah University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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). pii: E8. doi: 10.3390/brainsci6010008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0, 4 and 8 weeks
Secondary	Change in Numeric Pain Rating Scale	Paint rating scale from 0-10	0, 4 and 8 weeks
Secondary	Change in Short Form (SF) - 36	Survey of reported health	0, 4 and 8 weeks