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

Fibromyalgia Clinical Trial

Official title:

Lifestyle Physical Activity for Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383084
• Other study ID #: R01AR053168
• Secondary ID: R01AR053168AR053
• Status: Completed
• Phase: N/A
• First received: September 29, 2006
• Last updated: June 28, 2013
• Start date: September 2006
• Est. completion date: June 2010

Study information

• Verified date: June 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Culos-Reed SN, Brawley LR. Fibromyalgia, physical activity, and daily functioning: the importance of efficacy and health-related quality of life. Arthritis Care Res. 2000 Dec;13(6):343-51. — View Citation

Karper WB, Jannes CR, Hampton JL. Fibromyalgia syndrome: the beneficial effects of exercise. Rehabil Nurs. 2006 Sep-Oct;31(5):193-8. — View Citation

Oliver K, Cronan TA. Correlates of physical activity among women with fibromyalgia syndrome. Ann Behav Med. 2005 Feb;29(1):44-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory Pain (Higher Values Indicate Greater Pain)	0 to 100 pain rating, higher numbers indicate greater pain	Baseline and after 12-weeks	No
Primary	Ambulatory Fatigue, Higher Values Indicate Greater Fatigue	0-100 fatigue ratings, higher scores indicative of greater levels of fatigue	Baseline and after 12-weeks	No
Secondary	Number of Tender Points on the Body	Number of tender points on physical examination (maximum number is 18)	Baseline and after 12-weeks	No
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	Baseline and after 12-weeks	No