Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00383084|
Recruitment Status : Completed
First Posted : October 2, 2006
Results First Posted : July 1, 2013
Last Update Posted : September 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Lifestyle physical activity (LPA) Behavioral: Fibromyalgia education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Lifestyle Physical Activity for Fibromyalgia|
|Actual Study Start Date :||September 2006|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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)
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.
Active Comparator: 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.
Behavioral: Fibromyalgia 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.
- Ambulatory Pain (Higher Values Indicate Greater Pain) [ Time Frame: Baseline and after 12-weeks ]0 to 100 pain rating, higher numbers indicate greater pain
- Ambulatory Fatigue, Higher Values Indicate Greater Fatigue [ Time Frame: Baseline and after 12-weeks ]0-100 fatigue ratings, higher scores indicative of greater levels of fatigue
- Number of Tender Points on the Body [ Time Frame: Baseline and after 12-weeks ]Number of tender points on physical examination (maximum number is 18)
- Functional Capacity (Higher Scores Indicative of Poorer Functioning) [ Time Frame: Baseline and after 12-weeks ]Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383084
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21221|
|Principal Investigator:||Kevin Fontaine, PhD||Johns Hopkins University|