Lifestyle Physical Activity for Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Ambulatory Pain (Higher Values Indicate Greater Pain)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
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.
干预措施: Lifestyle physical activity (LPA) (Behavioral)
2
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.
干预措施: Fibromyalgia education (Behavioral)
结局指标
主要结局
Ambulatory Pain (Higher Values Indicate Greater Pain)
时间窗: Baseline and after 12-weeks
0 to 100 pain rating, higher numbers indicate greater pain
Ambulatory Fatigue, Higher Values Indicate Greater Fatigue
时间窗: Baseline and after 12-weeks
0-100 fatigue ratings, higher scores indicative of greater levels of fatigue
次要结局
- Number of Tender Points on the Body(Baseline and after 12-weeks)
- Functional Capacity (Higher Scores Indicative of Poorer Functioning)(Baseline and after 12-weeks)