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
Results First Received: January 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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  
Number of Participants  
[units: participants]
  46     38     84  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     46     38     84  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.4  ± 11.6     49  ± 10.2     47.7  ± 10.7  
Gender  
[units: participants]
     
Female     43     38     81  
Male     3     0     3  
Region of Enrollment  
[units: participants]
     
United States     46     38     84  



  Outcome Measures
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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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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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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:

Responsible Party: Kevin Fontaine, 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