Trial Outcomes & Findings for Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia (NCT NCT00383084)
NCT ID: NCT00383084
Last Updated: 2017-09-15
Results Overview
0 to 100 pain rating, higher numbers indicate greater pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Baseline and after 12-weeks
Results posted on
2017-09-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
38
|
|
Overall Study
COMPLETED
|
34
|
28
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
10
|
Baseline Characteristics
Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Lifestyle Physical Activity
n=46 Participants
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
n=38 Participants
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
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 11.6 • n=93 Participants
|
49 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
47.7 years
STANDARD_DEVIATION 10.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=93 Participants
|
38 participants
n=4 Participants
|
84 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 12-weeks0 to 100 pain rating, higher numbers indicate greater pain
Outcome measures
| Measure |
Lifestyle Physical Activity
n=46 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Ambulatory Pain (Higher Values Indicate Greater Pain)
Baseline
|
54.6 units on a scale
Standard Deviation 25.6
|
58.9 units on a scale
Standard Deviation 25
|
|
Ambulatory Pain (Higher Values Indicate Greater Pain)
After 12 Weeks
|
46.3 units on a scale
Standard Deviation 24.2
|
62.4 units on a scale
Standard Deviation 24.5
|
PRIMARY outcome
Timeframe: Baseline and after 12-weeks0-100 fatigue ratings, higher scores indicative of greater levels of fatigue
Outcome measures
| Measure |
Lifestyle Physical Activity
n=46 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Ambulatory Fatigue, Higher Values Indicate Greater Fatigue
Baseline
|
51.9 units on a scale
Standard Deviation 9.3
|
52.3 units on a scale
Standard Deviation 9.1
|
|
Ambulatory Fatigue, Higher Values Indicate Greater Fatigue
After 12 Weeks
|
50.6 units on a scale
Standard Deviation 9.9
|
51.4 units on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline and after 12-weeksNumber of tender points on physical examination (maximum number is 18)
Outcome measures
| Measure |
Lifestyle Physical Activity
n=46 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Number of Tender Points on the Body
Baseline
|
16.2 tender points
Standard Deviation 2.3
|
16.1 tender points
Standard Deviation 3.2
|
|
Number of Tender Points on the Body
After 12 Weeks
|
16 tender points
Standard Deviation 2.3
|
16.8 tender points
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline and after 12-weeksFibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100
Outcome measures
| Measure |
Lifestyle Physical Activity
n=46 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Functional Capacity (Higher Scores Indicative of Poorer Functioning)
Baseline
|
67.5 units on a scale
Standard Deviation 12
|
69.7 units on a scale
Standard Deviation 13.4
|
|
Functional Capacity (Higher Scores Indicative of Poorer Functioning)
After 12 Weeks
|
56.7 units on a scale
Standard Deviation 20.6
|
67 units on a scale
Standard Deviation 18.6
|
Adverse Events
Lifestyle Physical Activity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60