Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia
Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia
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).
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 stiffness, headaches, and mood disorders. The exact cause of FM is unknown, and
 currently, there is no cure. While exercise improves the symptoms of FM, pain and fatigue
 often prevent individuals from beginning an exercise regimen in the first place. Because of
 the known benefits of exercise on FM, it is important to find new ways for individuals with
 FM to increase their physical activity. Lifestyle physical activity, which involves any type
 of moderate-intensity activity such as walking, housecleaning, shopping, and gardening, may
 be more doable than structured exercise for individuals with FM. Also, lifestyle physical
 activity accumulated in short bouts over time can be as effective as single exercise sessions
 in producing health benefits. The purpose of this study is to determine the effect of daily
 30-minute lifestyle physical activity performed throughout the day on pain and fatigue in
 sedentary adults with FM.

 This study will last 12 weeks. Participants will be randomly assigned to one of two groups.
 Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical
 activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group
 sessions designed to help participants develop and maintain a more physically active
 lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these
 sessions. Group 2 participants will attend monthly FM educational sessions, which will focus
 on understanding the symptoms of FM, learning to manage pain and fatigue, and developing
 self-help strategies.

 Throughout the study, both Group 1 and 2 participants will wear a wristwatch-sized device
 that will track their physical activity and record pain and fatigue levels. Evaluations will
 occur at baseline, Week 12, and 6 and 12 months after Week 12 for all participants. At each
 of these time points, participants will complete questionnaires, and undergo pain
 evaluations, fitness testing, and a tender point examination.
Inclusion Criteria:

 -  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 Criteria:

 -  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