Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305890
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2006-03-20
Brief Title:
Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Duke University Pain Prevention Weight Management and Coping Skills Training For Patients With Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2013-08
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:
Osteoarthritis OA occurs when the cartilage between two bones becomes worn down and the bones begin to rub against each other in the joint This often leads to pain swelling decreased joint motion and the formation of bone spurs tiny growths of new bone Being overweight increases the risk of developing OA and fastens disease progression This study will evaluate two different programs lifestyle behavioral weight management and pain-coping skills training in reducing the effects of knee OA in obese individuals
Detailed Description:
Osteoarthritis is a chronic degenerative joint disorder that does not have a cure While OA can occur at almost any joint it most commonly occurs in the knee Obesity is a significant risk factor for the development of knee OA and is associated with faster disease progression Biomechanical inflammation and cognitive behavioral changes related to obesity can exacerbate OA pain and disability The purpose of this study is to develop more effective ways to treat individuals with knee OA Specifically the study will compare the effectiveness of a lifestyle behavioral weight management program pain-coping skills training and standard care in improving OA symptoms and day-to-day function in obese individuals with OA in one or both knees
The study treatment groups will meet for a total of 6 months Participants will be randomly assigned to one of four conditions 1 lifestyle behavioral weight management program 2 pain-coping skills training 3 lifestyle behavioral weight management program plus pain-coping skills training or 4 standard care The lifestyle behavioral weight management program will focus on lifestyle exercise attitudes relationships and nutrition The pain-coping skills training will focus on minimizing maladaptive over-reactions and enhancing adaptive strategies to control and decrease pain Standard care will include routine medical care
Participants in the first three conditions will attend 12 weekly group sessions followed by 6 every-other-week group sessions After completing treatment participants will receive monthly follow-up telephone calls to facilitate the post-treatment transition There will be a total of four evaluations during this study immediately prior to treatment immediately after treatment and 6 and 12 months following the end of treatment During each evaluation blood and urine will be collected to analyze disease biomarkers An exercise treadmill test and height weight and body mass index measures will be used to assess aerobic fitness Lower extremity function will be measured with the Up and Go performance test Participants will also be videotaped while walking to evaluate gait and will be asked to fill out a series of questionnaires Medication use will be reviewed during an interview During the first evaluation x-rays will be taken to measure disease activity
Participants completing the study intervention and all four follow-up evaluations will be eligible to join the second part of the study examining the relationship between food intake mood activity level and pain Participants will complete a series of questionnaires at baseline and 2-day diaries in which they rate mood pain and activity level and they record food intake triggered at random times throughout the day A follow-up visit to complete additional questionnaires will be conducted 6 months later Blood samples will also be collected for future analysis of genetic markers of pain sensitivity
The study treatment groups will meet for a total of 6 months Participants will be randomly assigned to one of four conditions 1 lifestyle behavioral weight management program 2 pain-coping skills training 3 lifestyle behavioral weight management program plus pain-coping skills training or 4 standard care The lifestyle behavioral weight management program will focus on lifestyle exercise attitudes relationships and nutrition The pain-coping skills training will focus on minimizing maladaptive over-reactions and enhancing adaptive strategies to control and decrease pain Standard care will include routine medical care
Participants in the first three conditions will attend 12 weekly group sessions followed by 6 every-other-week group sessions After completing treatment participants will receive monthly follow-up telephone calls to facilitate the post-treatment transition There will be a total of four evaluations during this study immediately prior to treatment immediately after treatment and 6 and 12 months following the end of treatment During each evaluation blood and urine will be collected to analyze disease biomarkers An exercise treadmill test and height weight and body mass index measures will be used to assess aerobic fitness Lower extremity function will be measured with the Up and Go performance test Participants will also be videotaped while walking to evaluate gait and will be asked to fill out a series of questionnaires Medication use will be reviewed during an interview During the first evaluation x-rays will be taken to measure disease activity
Participants completing the study intervention and all four follow-up evaluations will be eligible to join the second part of the study examining the relationship between food intake mood activity level and pain Participants will complete a series of questionnaires at baseline and 2-day diaries in which they rate mood pain and activity level and they record food intake triggered at random times throughout the day A follow-up visit to complete additional questionnaires will be conducted 6 months later Blood samples will also be collected for future analysis of genetic markers of pain sensitivity
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 |
|---|---|---|---|
| P01AR050245 | NIH | None | None |
| NIAMS-4927 | None | None | None |
| 1P01AR050245-03 | NIH | None | httpsreporternihgovquickSearch1P01AR050245-03 |