Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00383084
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2006-09-29
Brief Title:
Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Lifestyle Physical Activity for Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AR053168-01-A1 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR053168 |
| R01AR053168 | NIH | None | None |