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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
Bi-weekly, 60-minute group sessions spread over 12 weeks. Participants will receive education on how to increase their daily physical activity, goal setting, problem solving strategies to overcome barriers to being more physically active, and finding new ways to integrate short bouts of LPA into their daily lives.
Participants will meet monthly for 1.5 to 2 hours for a total of 3 months. The sessions will be divided into three components: (1) education, (2) question and answer, and (3) social support.
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Ambulatory Pain (Higher Values Indicate Greater Pain)
0 to 100 pain rating, higher numbers indicate greater pain
Time frame: Baseline and after 12-weeks
Ambulatory Fatigue, Higher Values Indicate Greater Fatigue
0-100 fatigue ratings, higher scores indicative of greater levels of fatigue
Time frame: Baseline and after 12-weeks
Number of Tender Points on the Body
Number of tender points on physical examination (maximum number is 18)
Time frame: Baseline and after 12-weeks
Functional Capacity (Higher Scores Indicative of Poorer Functioning)
Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100
Time frame: Baseline and after 12-weeks
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