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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00383084
First Posted: October 2, 2006
Last Update Posted: September 15, 2017
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.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: January 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Behavioral: Lifestyle physical activity (LPA)
Behavioral: Fibromyalgia education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lifestyle Physical Activity 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.
Education 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.

Participant Flow:   Overall Study
    Lifestyle Physical Activity   Education
STARTED   46   38 
COMPLETED   34   28 
NOT COMPLETED   12   10 
Withdrawal by Subject                12                10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Lifestyle Physical Activity 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.
Education 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.
Total Total of all reporting groups

Baseline Measures
   Lifestyle Physical Activity   Education   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   38   84 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      46 100.0%      38 100.0%      84 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.4  (11.6)   49  (10.2)   47.7  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      43  93.5%      38 100.0%      81  96.4% 
Male      3   6.5%      0   0.0%      3   3.6% 
Region of Enrollment 
[Units: Participants]
     
United States   46   38   84 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ambulatory Pain (Higher Values Indicate Greater Pain)   [ Time Frame: Baseline and after 12-weeks ]

2.  Primary:   Ambulatory Fatigue, Higher Values Indicate Greater Fatigue   [ Time Frame: Baseline and after 12-weeks ]

3.  Secondary:   Number of Tender Points on the Body   [ Time Frame: Baseline and after 12-weeks ]

4.  Secondary:   Functional Capacity (Higher Scores Indicative of Poorer Functioning)   [ Time Frame: Baseline and after 12-weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kevin Fontaine, PhD
Organization: Johns Hopkins University
phone: 443-449-4314
e-mail: kfontai1@jhmi.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00383084     History of Changes
Other Study ID Numbers: R01AR053168 ( U.S. NIH Grant/Contract )
AR053168-01-A1
First Submitted: September 29, 2006
First Posted: October 2, 2006
Results First Submitted: January 29, 2013
Results First Posted: July 1, 2013
Last Update Posted: September 15, 2017