Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia

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