Recruiting

Self Directed Exercise

Sponsor:

Shenandoah University

Code:

NCT03400527

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Exercise

Study Details

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 ID

NCT03400527

Start date

Mar 30, 2018

Status verified date

Apr, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise

Participant will be pedaling a stationary exercise bicycle

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

Primary outcome measure

  • Change in Fibromyalgia Impact Questionnaire [ Time Frame: 0, 4 and 8 weeks ]

Central Contacts and Locations

Locations

Woodstock Rehab & Fitness

Recruiting

Woodstock, Virginia, United States, 22664

Contacts

AJ Lievre, DPT

540-665-5522alievre@su.edu

More Information

Sponsor

Shenandoah University

Last update posted

Apr 24, 2018

Last verified

Apr, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shenandoah University on 2018-04-24.