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

Not Applicable

Completed

Conditions: Fibromyalgia

Interventions: Behavioral: Fibromyalgia education
Behavioral: Lifestyle physical activity (LPA)

Registration Number: NCT00383084

Lead Sponsor: Johns Hopkins University

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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 84

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Fibromyalgia 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.
1	Lifestyle physical activity (LPA)	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.

Primary Outcome Measures

Name	Time	Method
Ambulatory Pain (Higher Values Indicate Greater Pain)	Baseline and after 12-weeks	0 to 100 pain rating, higher numbers indicate greater pain
Ambulatory Fatigue, Higher Values Indicate Greater Fatigue	Baseline and after 12-weeks	0-100 fatigue ratings, higher scores indicative of greater levels of fatigue

Secondary Outcome Measures

Name	Time	Method
Number of Tender Points on the Body	Baseline and after 12-weeks	Number of tender points on physical examination (maximum number is 18)
Functional Capacity (Higher Scores Indicative of Poorer Functioning)	Baseline and after 12-weeks	Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100