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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kevin Fontaine, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00383084
First received: September 29, 2006
Last updated: June 28, 2013
Last verified: June 2013
  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:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Ambulatory Pain (Higher Values Indicate Greater Pain) [ Time Frame: Baseline and after 12-weeks ] [ Designated as safety issue: No ]
    0 to 100 pain rating, higher numbers indicate greater pain

  • Ambulatory Fatigue, Higher Values Indicate Greater Fatigue [ Time Frame: Baseline and after 12-weeks ] [ Designated as safety issue: No ]
    0-100 fatigue ratings, higher scores indicative of greater levels of fatigue


Secondary Outcome Measures:
  • Number of Tender Points on the Body [ Time Frame: Baseline and after 12-weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100


Enrollment: 84
Study Start Date: September 2006
Study Completion Date: June 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21221
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Kevin Fontaine, PhD Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Fontaine, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00383084     History of Changes
Other Study ID Numbers: R01 AR053168, R01AR053168, AR053168-01-A1
Study First Received: September 29, 2006
Results First Received: January 29, 2013
Last Updated: June 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Pain
Physical Activity
Fatigue
Lifestyle Activity

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

ClinicalTrials.gov processed this record on November 23, 2014