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| Tracking Information | |||||
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| First Received Date ICMJE | September 29, 2006 | ||||
| Last Updated Date | March 31, 2009 | ||||
| Start Date ICMJE | September 2006 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00383084 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia | ||||
| Official Title ICMJE | Lifestyle Physical Activity for Fibromyalgia | ||||
| 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). |
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| 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 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Fibromyalgia | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 160 | ||||
| Estimated Completion Date | June 2010 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00383084 | ||||
| Responsible Party | Kevin Fontaine, PhD - Associate Professor of Medicine, Johns Hopkins University School of Medicine | ||||
| Study ID Numbers ICMJE | R01 AR053168, AR053168-01-A1 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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