Duloxetine and aeRobic Exercise to Improve Function in VEterans With Knee Osteoarthritis (DRIVE)

Summary

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.

Conditions

• Knee Osteoarthritis
• Pain
• Depression

Interventions

BEHAVIORAL

Exercise

Participants will be asked to participate in a 1x/week center-based exercise session and 2x/week walking session conducted on their own for \~12 weeks.

DRUG

Duloxetine

Participants will receive study medication - duloxetine - and take medication as directed.

DRUG

Placebo

Participants will receive study medication - matched placebo- and take as directed.

BEHAVIORAL

PT referral

Participants will be referred to physical therapy with treatment as part of usual care and individualized to the Veteran's needs.

Sponsors & Collaborators

• Baltimore VA Medical Center

  collaborator FED

• VA Office of Research and Development

  lead FED

Principal Investigators

• Alan M Rathbun, PhD MPH · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

• Alice S. Ryan, PhD · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2027-03-01

Primary Completion

2031-09-01

Completion

2032-09-01

FDA Drug

Yes

Countries

• United States

Study Locations