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

This study is currently recruiting participants.
Verified by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), March 2009
First Received: September 29, 2006 Last Updated: March 31, 2009

Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00383084

Purpose
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).

Condition Intervention
Fibromyalgia Behavioral: Lifestyle physical activity (LPA)
Behavioral: Fibromyalgia education

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Active Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment Official Title: Lifestyle Physical Activity for Fibromyalgia

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Primary Outcome Measures:

  • Ambulatory pain [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Ambulatory fatigue [ Time Frame: Daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Tenderness [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Physical activity (measured by an accelerometer) [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Functional capacity [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Pain perception [ Time Frame: 30-45 minutes ] [ Designated as safety issue: No ]
  • Metabolic efficiency [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2006
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions

1: Experimental
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.
Intervention: Behavioral: Lifestyle
physical activity (LPA)

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.

 

 

2: Active Comparator 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. Intervention: Behavioral: Fibromyalgia
education

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.

 

Eligibility
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
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
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