The Effects of Self Directed Exercise on People With Fibromyalgia

NCT ID: NCT03400527

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-30
• Study Completion Date: 2018-12-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

Participant will be pedaling a stationary exercise bicycle

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shenandoah University

OTHER

Sponsor Role: lead

Responsible Party

AJ Lievre

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Woodstock Rehab & Fitness

Woodstock, Virginia, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

AJ Lievre, DPT

Role: primary

alievre@su.edu

540-665-5522

References

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):8. doi: 10.3390/brainsci6010008.

Reference Type: BACKGROUND

PMID: 26927193 (View on PubMed)

Other Identifiers

SUPT 5

Identifier Type: -

Identifier Source: org_study_id