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

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ClinicalTrials.gov Identifier: NCT00383084
Recruitment Status : Completed
First Posted : October 2, 2006
Results First Posted : July 1, 2013
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Johns Hopkins University

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
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lifestyle Physical Activity Education
Hide Arm/Group Description 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 fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
Period Title: Overall Study
Started 46 38
Completed 34 28
Not Completed 12 10
Reason Not Completed
Withdrawal by Subject             12             10
Arm/Group Title Lifestyle Physical Activity Education Total
Hide Arm/Group Description 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 fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies. Total of all reporting groups
Overall Number of Baseline Participants 46 38 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 38 participants 84 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 38 participants 84 participants
46.4  (11.6) 49  (10.2) 47.7  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 38 participants 84 participants
Female
43
  93.5%
38
 100.0%
81
  96.4%
Male
3
   6.5%
0
   0.0%
3
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 38 participants 84 participants
46 38 84
1.Primary Outcome
Title Ambulatory Pain (Higher Values Indicate Greater Pain)
Hide Description 0 to 100 pain rating, higher numbers indicate greater pain
Time Frame Baseline and after 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Physical Activity Education
Hide Arm/Group Description:
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 fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
Overall Number of Participants Analyzed 46 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 54.6  (25.6) 58.9  (25)
After 12 Weeks 46.3  (24.2) 62.4  (24.5)
2.Primary Outcome
Title Ambulatory Fatigue, Higher Values Indicate Greater Fatigue
Hide Description 0-100 fatigue ratings, higher scores indicative of greater levels of fatigue
Time Frame Baseline and after 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Physical Activity Education
Hide Arm/Group Description:
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 fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
Overall Number of Participants Analyzed 46 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 51.9  (9.3) 52.3  (9.1)
After 12 Weeks 50.6  (9.9) 51.4  (10.1)
3.Secondary Outcome
Title Number of Tender Points on the Body
Hide Description Number of tender points on physical examination (maximum number is 18)
Time Frame Baseline and after 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Physical Activity Education
Hide Arm/Group Description:
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 fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
Overall Number of Participants Analyzed 46 38
Mean (Standard Deviation)
Unit of Measure: tender points
Baseline 16.2  (2.3) 16.1  (3.2)
After 12 Weeks 16  (2.3) 16.8  (2.0)
4.Secondary Outcome
Title Functional Capacity (Higher Scores Indicative of Poorer Functioning)
Hide Description Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100
Time Frame Baseline and after 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Physical Activity Education
Hide Arm/Group Description:
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 fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
Overall Number of Participants Analyzed 46 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 67.5  (12) 69.7  (13.4)
After 12 Weeks 56.7  (20.6) 67  (18.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lifestyle Physical Activity Education
Hide Arm/Group Description 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 fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
All-Cause Mortality
Lifestyle Physical Activity Education
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lifestyle Physical Activity Education
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Lifestyle Physical Activity Education
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/38 (0.00%) 
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
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00383084     History of Changes
Other Study ID Numbers: R01AR053168 ( U.S. NIH Grant/Contract )
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