Fibromyalgia
Conditions
Keywords
Pain, Physical Activity, Fatigue, Lifestyle Activity
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.
Interventions
BEHAVIORALLifestyle physical activity (LPA)
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.
BEHAVIORALFibromyalgia education
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.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| 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. | 38 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 12 | 10 |
Baseline characteristics
| Characteristic | Lifestyle Physical Activity | Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 38 Participants | 84 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 11.6 | 49 years STANDARD_DEVIATION 10.2 | 47.7 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 46 participants | 38 participants | 84 participants |
| Sex: Female, Male Female | 43 Participants | 38 Participants | 81 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 38 |
| serious Total, serious adverse events | 0 / 46 | 0 / 38 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Physical Activity | Ambulatory Fatigue, Higher Values Indicate Greater Fatigue | After 12 Weeks | 50.6 units on a scale | Standard Deviation 9.9 |
| Lifestyle Physical Activity | Ambulatory Fatigue, Higher Values Indicate Greater Fatigue | Baseline | 51.9 units on a scale | Standard Deviation 9.3 |
| Education | Ambulatory Fatigue, Higher Values Indicate Greater Fatigue | Baseline | 52.3 units on a scale | Standard Deviation 9.1 |
| Education | Ambulatory Fatigue, Higher Values Indicate Greater Fatigue | After 12 Weeks | 51.4 units on a scale | Standard Deviation 10.1 |
Primary
Ambulatory Pain (Higher Values Indicate Greater Pain)
0 to 100 pain rating, higher numbers indicate greater pain
Time frame: Baseline and after 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Physical Activity | Ambulatory Pain (Higher Values Indicate Greater Pain) | Baseline | 54.6 units on a scale | Standard Deviation 25.6 |
| Lifestyle Physical Activity | Ambulatory Pain (Higher Values Indicate Greater Pain) | After 12 Weeks | 46.3 units on a scale | Standard Deviation 24.2 |
| Education | Ambulatory Pain (Higher Values Indicate Greater Pain) | Baseline | 58.9 units on a scale | Standard Deviation 25 |
| Education | Ambulatory Pain (Higher Values Indicate Greater Pain) | After 12 Weeks | 62.4 units on a scale | Standard Deviation 24.5 |
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
Time frame: Baseline and after 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Physical Activity | Functional Capacity (Higher Scores Indicative of Poorer Functioning) | Baseline | 67.5 units on a scale | Standard Deviation 12 |
| Lifestyle Physical Activity | Functional Capacity (Higher Scores Indicative of Poorer Functioning) | After 12 Weeks | 56.7 units on a scale | Standard Deviation 20.6 |
| Education | Functional Capacity (Higher Scores Indicative of Poorer Functioning) | Baseline | 69.7 units on a scale | Standard Deviation 13.4 |
| Education | Functional Capacity (Higher Scores Indicative of Poorer Functioning) | After 12 Weeks | 67 units on a scale | Standard Deviation 18.6 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Physical Activity | Number of Tender Points on the Body | Baseline | 16.2 tender points | Standard Deviation 2.3 |
| Lifestyle Physical Activity | Number of Tender Points on the Body | After 12 Weeks | 16 tender points | Standard Deviation 2.3 |
| Education | Number of Tender Points on the Body | Baseline | 16.1 tender points | Standard Deviation 3.2 |
| Education | Number of Tender Points on the Body | After 12 Weeks | 16.8 tender points | Standard Deviation 2 |