Fibromyalgia Clinical Trial
Official title:
Lifestyle Physical Activity for 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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