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Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).   Recruitment status was  Recruiting

First Received on September 29, 2006.   Last Updated on March 31, 2009   History of Changes
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Lifestyle Physical Activity for Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Fibromyalgia
U.S. FDA Resources

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
Experimental: 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.
 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.

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.

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383084

Contacts
Contact: Kevin Fontaine, PhD 410-550-2517 kfontai1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21221
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Kevin Fontaine, PhD Johns Hopkins University
  More Information

Publications:
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.
Karper WB, Jannes CR, Hampton JL. Fibromyalgia syndrome: the beneficial effects of exercise. Rehabil Nurs. 2006 Sep-Oct;31(5):193-8.
Oliver K, Cronan TA. Correlates of physical activity among women with fibromyalgia syndrome. Ann Behav Med. 2005 Feb;29(1):44-53.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Fontaine KR, Conn L, Clauw DJ. Effects of lifestyle physical activity in adults with fibromyalgia: results at follow-up. J Clin Rheumatol. 2011 Mar;17(2):64-8.
Fontaine KR, Conn L, Clauw DJ. Effects of lifestyle physical activity on perceived symptoms and physical function in adults with fibromyalgia: results of a randomized trial. Arthritis Res Ther. 2010;12(2):R55. Epub 2010 Mar 30.

Responsible Party: Kevin Fontaine, PhD - Associate Professor of Medicine, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00383084     History of Changes
Other Study ID Numbers: R01 AR053168, AR053168-01-A1
Study First Received: September 29, 2006
Last Updated: March 31, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Pain
Physical Activity
Fatigue
Lifestyle Activity

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 13, 2012



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