Status:
COMPLETED
Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effect of 3 months of daily, 30-minute lifestyle physical activity on pain and fatigue in inactive adults with fibromyalgia (FM).
Detailed Description
FM is characterized by muscle pain, fatigue, and "tender points," specific places on the body that hurt when pressure is applied. Individuals with FM may also experience trouble sleeping, morning stif...
Eligibility Criteria
Inclusion
- Meets American College of Rheumatology (ACR) criteria for FM
- Inactive at study entry
- Willing to become more physically active
- Understands and willing to follow study recommendations regarding lifestyle modification
- Able to participate in the study for 2 years
- Agrees to not make any changes to current FM-related treatments
Exclusion
- Any comorbidity that may worsen a participant's physical functioning, independent of FM (e.g., significant cardiovascular disease, history of arrhythmias, morbid obesity, autoimmune diseases, uncontrolled or untreated hypertension, significant renal or prostate disease, stroke, seizure disorder, any other significant neurological diseases)
- Significant peripheral neuropathy
- Any current psychiatric disorder that involves a history of psychosis, including schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar disorder, or severe personality disorder. Participants with mood disorder are not excluded.
- Alcohol or substance abuse within the 2 years prior to study entry
- Current suicide risk or suicide attempt within the 2 years prior to study entry
- Severe physical disability that may interfere with physical activity
- Currently participates in structured exercise or plans to participate in an exercise program
- Any investigational medications or devices within 4 weeks prior to study entry
- Any expected life change, such as relocation, within the next 2 years that may prevent study participation
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00383084
Start Date
September 1 2006
End Date
June 1 2010
Last Update
September 15 2017
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21221