Ignite Creation Date:
2024-05-06 @ 1:46 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04111627
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2019-09-18
Brief Title:
Exercise Plus Duloxetine for Knee Osteoarthritis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Feasibility and Pilot Study of Combined Treatment Protocol Using Aerobic Exercise and Duloxetine in Older Adults With Symptomatic Knee Osteoarthritis and Comorbid Depression
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of symptomatic knee osteoarthritis and depressive symptoms in adults All participants will receive the receive the treatment protocol which will first be evaluated in terms of feasibility and then pilot tested
Detailed Description:
Symptomatic knee osteoarthritis OA affects 10 of men and 13 of women 60 years or older and depressive symptoms are common occurring in one-fifth of these patients Depressive symptoms worsen knee OA disease severity and are a barrier to pain management and engagement in physical activity Guidelines recommend depression treatment in older adults with knee OA but provide no direction on how to simultaneously manage the co-occurrence of physical and mental morbidity Treatment recommendations advise exercise to manage pain and disability and improve psychosocial health in knee OA patients however compliance to exercise programs is low in persons with chronic pain and disability and is only made worse by comorbid depression Adherence is critical to the efficacy of depression treatments using exercise training and no such exercise program has ever been designed for and tested in OA patients with co-occurring depressive symptoms in a way to enhance compliance Duloxetine is the only antidepressant medication indicated for pain management in knee OA patients that has demonstrated efficacy and tolerability when treating depression in older adults and is a viable pharmacological complement to exercise There are no protocols that combine treatments using interventions that affect symptoms of both knee OA and depression and the study goals are to evaluate the feasibility of and then pilot test a protocol comprised of aerobic exercise training plus duloxetine for the treatment of symptomatic knee OA and comorbid depression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K01AG064041 | NIH | None | httpsreporternihgovquickSearchK01AG064041 |