Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321659
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2006-05-03
Brief Title:
Optimizing Fibromyalgia Self-management
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2017-03
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 overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management The purpose of this research project is to evaluate and compare in a randomized controlled trial involving 200 women the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status self-efficacy and symptom severity Additionally we will also examine the effect of each intervention on health care usage We will assess the following 16-week interventions
cardiovascular and flexibility exercise
strength training cardiovascular and flexibility exercise
Arthritis Foundations Fibromyalgia Self-Help course
a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions
cardiovascular and flexibility exercise
strength training cardiovascular and flexibility exercise
Arthritis Foundations Fibromyalgia Self-Help course
a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions
Detailed Description:
Fibromyalgia syndrome FMS is a common chronic musculoskeletal disorder and a growing cause of disability and increased health care utilization Current treatment focuses largely on pharmacological interventions which are often ineffective at improving symptoms and functional status Recent research suggests that disease self-management can be efficacious in the short-term at reducing symptom severity and improving function in persons with FMS The most common forms of FMS self-management are coping skills training behavioraleducation and exercise Limited in number most FMS self-management studies examine the short-term effects of one form or the other with most using the coping skills training approach Little data exist to examine the long-term effects of these interventions the potential additive effect of combining coping skills training with a comprehensive group exercise program or an approach for promoting long-term compliance of these interventions The objective of this proposal is to identify the optimal approach to FMS self-management The study is a randomized controlled trial comparing coping skills training the Arthritis Foundation Fibromyalgia Self-Help Course FSHC with two exercise programs - cardiovascular and flexibility training with and without strength training - and a combination the FSHC plus the strength training exercise program Each intervention period will last 16 weeks and include group sessions led by trained personnel Subjects will be followed for 6 months after completing the intervention to evaluate the short-term effect of each program At 6 months subjects will be randomized into two groups-one group will receive a 4 week refresher course of their original intervention every 6 months and the other group will receive no further intervention Long-term follow up will be for 24 months after completing the 16 week intervention period Subjects will include 200 women four groups of 50 25 to 65 years old with a confirmed diagnosis of FMS Participants will undergo blinded assessment at the Beth Israel Deaconess Medical Centers GCRC at five time points-baseline completion of the 16-week intervention and 6 12 and 24 month follow up We will assess health and functional status FIQ SF36 symptom severity FIQ SF36 Beck scales self-efficacy Arthritis Self-Efficacy Scale fitness muscle strength cardiovascular fitness flexibility and health care utilization direct and indirect costs The study will improve treatment outcomes for persons with FMS by identifying the optimal self-management program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| K23AR048305 | NIH | None | httpsreporternihgovquickSearchK23AR048305 |