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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Lifestyle Physical Activity for Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Lifestyle physical activity (LPA)
* Behavioral: Fibromyalgia education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Behavioral: Lifestyle physical activity (LPA)<br>* 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.<br>|
| Active Comparator: 2<br>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. | Behavioral: Fibromyalgia education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100 | Baseline and after 12-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Physical Activity, Fatigue, Lifestyle Activity