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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR053168 | U.S. NIH Grant/Contract | View source | |
| AR053168-01-A1 |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
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| 2 | Active Comparator | Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle physical activity (LPA) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory Pain (Higher Values Indicate Greater Pain) | 0 to 100 pain rating, higher numbers indicate greater pain | Baseline and after 12-weeks |
| Ambulatory Fatigue, Higher Values Indicate Greater Fatigue | 0-100 fatigue ratings, higher scores indicative of greater levels of fatigue | Baseline and after 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Tender Points on the Body | Number of tender points on physical examination (maximum number is 18) | Baseline and after 12-weeks |
| Functional Capacity (Higher Scores Indicative of Poorer Functioning) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Fontaine, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21221 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14635309 | Background | Culos-Reed SN, Brawley LR. Fibromyalgia, physical activity, and daily functioning: the importance of efficacy and health-related quality of life. Arthritis Care Res. 2000 Dec;13(6):343-51. doi: 10.1002/1529-0131(200012)13:63.0.co;2-p. | |
| 16948441 | Background | Karper WB, Jannes CR, Hampton JL. Fibromyalgia syndrome: the beneficial effects of exercise. Rehabil Nurs. 2006 Sep-Oct;31(5):193-8. doi: 10.1002/j.2048-7940.2006.tb00135.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Physical Activity | 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. |
| FG001 | Education | Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Physical Activity | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ambulatory Pain (Higher Values Indicate Greater Pain) | 0 to 100 pain rating, higher numbers indicate greater pain | Posted | Mean | Standard Deviation | units on a scale | Baseline and after 12-weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifestyle Physical Activity | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Fontaine, PhD | Johns Hopkins University | 443-449-4314 | kfontai1@jhmi.edu |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Fibromyalgia education | Behavioral | 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. |
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Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100
| Baseline and after 12-weeks |
| 15677300 | Background | Oliver K, Cronan TA. Correlates of physical activity among women with fibromyalgia syndrome. Ann Behav Med. 2005 Feb;29(1):44-53. doi: 10.1207/s15324796abm2901_7. |
| 23098173 | Derived | Campbell CM, McCauley L, Bounds SC, Mathur VA, Conn L, Simango M, Edwards RR, Fontaine KR. Changes in pain catastrophizing predict later changes in fibromyalgia clinical and experimental pain report: cross-lagged panel analyses of dispositional and situational catastrophizing. Arthritis Res Ther. 2012 Oct 25;14(5):R231. doi: 10.1186/ar4073. |
| 21325963 | Derived | Fontaine KR, Conn L, Clauw DJ. Effects of lifestyle physical activity in adults with fibromyalgia: results at follow-up. J Clin Rheumatol. 2011 Mar;17(2):64-8. doi: 10.1097/RHU.0b013e31820e7ea7. |
| 20353551 | Derived | Fontaine KR, Conn L, Clauw DJ. Effects of lifestyle physical activity on perceived symptoms and physical function in adults with fibromyalgia: results of a randomized trial. Arthritis Res Ther. 2010;12(2):R55. doi: 10.1186/ar2967. Epub 2010 Mar 30. |
| BG001 | Education | Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Ambulatory Fatigue, Higher Values Indicate Greater Fatigue | 0-100 fatigue ratings, higher scores indicative of greater levels of fatigue | Posted | Mean | Standard Deviation | units on a scale | Baseline and after 12-weeks |
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| Secondary | Number of Tender Points on the Body | Number of tender points on physical examination (maximum number is 18) | Posted | Mean | Standard Deviation | tender points | Baseline and after 12-weeks |
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| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline and after 12-weeks |
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|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Education | Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies. | 0 | 38 | 0 | 38 |
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| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |