About this trial
Knee osteoarthritis (KOA) is one of the most common causes of chronic pain, mobility problems, and disability among United States Veterans. Many Veterans with KOA also experience depressive symptoms, which can worsen pain, reduce motivation to exercise, and make recovery more difficult. This study will test whether a structured hybrid aerobic exercise program that combines supervised and home-based walking with the medication duloxetine can improve physical function, reduce pain, lessen depressive symptoms, and improve overall health-related outcomes in Veterans with KOA. The goal of this research is to develop a practical and scalable treatment strategy that could improve rehabilitation and quality of life for Veterans with chronic knee pain and depressive symptoms and potentially be adapted for other chronic musculoskeletal conditions treated within the VA healthcare system.
Eligibility criteria
Qualifiers
Veterans aged ≥40 years
English-speaking
symptomatic KOA based on American College of Rheumatology (ACR) criteria
Patient Health Questionnaire-9 (PHQ-9) scores indicating mild to severe depressive symptoms
Disqualifiers
current use of antidepressants, opioids, benzodiazepines, or antipsychotics
engaging in structured aerobic or resistance exercise ≥3 times per week
cognitive impairment defined as a Mini-Mental State Examination (MMSE) score <20
diagnosis of bipolar disorder, psychosis, recent substance use disorder, or suicidal ideation per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Trial design
Treatments tested in this trial
- Exercise
- Duloxetine
- Placebo
- PT referral
Treatment groups
Sponsors and collaborators
VA Office of Research and Development
Lead sponsor
Baltimore VA Medical Center
Collaborator