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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
VA Office of Research and Development
Study ID
NCT07649291
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Exercise — BEHAVIORAL
    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.
  • Duloxetine — DRUG
    Participants will receive study medication - duloxetine - and take medication as directed.
  • Placebo — DRUG
    Participants will receive study medication - matched placebo- and take as directed.
  • PT referral — BEHAVIORAL
    Participants will be referred to physical therapy with treatment as part of usual care and individualized to the Veteran's needs.

Study Details

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.

Key Dates

Start date
Mar 1, 2027
Status verified
Jun 2026
Primary completion
Sep 1, 2031
Completion
Sep 1, 2032

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Exercise+Duloxetine
    hybrid supervised aerobic exercise plus duloxetine
  • Active Comparator: Duloxetine+PT referral
    duloxetine plus physical therapy (PT) referral
  • Active Comparator: Exercise+Placebo
    hybrid supervised aerobic exercise plus placebo

Primary Outcome Measure

20-Meter Walk Test [ Time Frame: baseline, 12-week follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimoreMaryland21201
Alice S Ryan, PhD
[email protected]
410-605-7851
Alan M Rathbun, PhD MPH (PRINCIPAL_INVESTIGATOR)
Alice S. Ryan, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
DepressionOsteoarthritis (other)
By specialty
PsychiatryMental healthBehavioral healthOrthopedicsMusculoskeletal disorders
By research site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD· Baltimore, MD

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