Health TrialsbyHealthPanel

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

ConditionsKnee OsteoarthritisPainDepression
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorVA Office of Research and Development

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

102 Participants
are divided into 3 treatment groups
Group A: Exercise+DuloxetineActive comparator 2 interventions
Group B: Duloxetine+PT referralActive comparator 2 interventions
Group C: Exercise+PlaceboActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

20-Meter Walk Test

20m WT (average time to walk 20 meters at usual pace across two trials) from baseline to 12 weeks, and between-group comparison (aerobic exercise + duloxetine vs. PT referral + duloxetine)

Time frame
baseline, 12-week follow-up

Secondary outcomes

1

Pain severity

The Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale is a patient-reported measure of knee pain consisting of 9 items. Scores are transformed to a 0-100 scale, where 0 represents extreme knee pain and 100 represents no knee pain. Higher scores indicate better outcomes (less pain). KOOS Pain is a self-report measure with five subscales. The pain subscale will be the pain outcome.

Time frame
baseline, 12-week follow-up
2

Depressive symptoms

The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered measure of depressive symptom severity. Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms and worse outcomes. Lower scores indicate improvement in depressive symptoms. Hamilton Depression Rating Scale (HAM-D) is a 17-item interviewer-administered scale.

Time frame
baseline, 12-week follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Baltimore VA Medical Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: