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

10. juni 2026 oppdatert av: VA Office of Research and Development

Duloxetine Plus Exercise to Improve Physical Function in Veterans With Knee Osteoarthritis, Pain, and Psychological Comorbidity

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Knee osteoarthritis (KOA) and depressive symptoms are both common among older adults and Veterans and are major contributors to chronic pain, reduced mobility, declines in physical function, disability, and poorer overall health outcomes. Veterans with KOA frequently experience co-occurring depressive symptoms, which can worsen pain, interfere with rehabilitation, and reduce adherence to exercise and other self-management strategies. Existing VA care guidelines generally treat KOA and depressive symptoms separately, and there remains limited evidence supporting integrated interventions that target both conditions simultaneously while also improving physical function.

Current knowledge gaps include how to optimize adherence to aerobic exercise among individuals with pain and depressive symptoms and whether combining pharmacologic and rehabilitative approaches provides greater benefit than usual care alone. Aerobic exercise is a recommended first-line treatment for KOA and can improve both mood and physical function, but sustained participation is often difficult in individuals with chronic pain and depressive symptoms. Similarly, duloxetine has demonstrated benefits for both depressive symptoms and KOA-related pain, although interventions targeting only one condition have generally produced limited effects.

Preliminary work conducted by the study team demonstrated that combining duloxetine with a hybrid supervised aerobic exercise program that included both center-based and home-based walking components was feasible and acceptable among individuals with symptomatic KOA and depressive symptoms. Participants experienced clinically meaningful improvements in pain, activities of daily living, walking ability, endurance, psychological symptoms, self-efficacy, and willingness to engage in pain self-management strategies. These findings support the rationale for the proposed study and the evaluation of a complementary care model integrating pharmacologic and non-pharmacologic treatments for Veterans with KOA and depressive symptoms. This study is a Phase II, three-arm, randomized clinical trial designed to evaluate the efficacy of a hybrid supervised aerobic exercise program combined with duloxetine among Veterans with symptomatic knee osteoarthritis and depressive symptoms.

Studietype

Intervensjonell

Registrering (Antatt)

102

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
        • Hovedetterforsker:
          • Alice S. Ryan, PhD
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alan M Rathbun, PhD MPH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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
  • no planned knee surgery within the next 6 months
  • ability to participate in supervised aerobic exercise

Exclusion Criteria:

  • 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)
  • medical conditions contraindicating exercise (e.g., recent myocardial infarction, unstable angina, peripheral arterial disease with ulcers, -uncontrolled hypertension >190/110, or New York Heart Association class ≥3 cardiac or pulmonary disease)
  • pregnant or lactating individuals
  • active cancer that is currently undergoing treatment (receiving chemotherapy and/or radiation therapy
  • other conditions deemed by study team to endanger the health of the participant

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Exercise+Duloxetine
hybrid supervised aerobic exercise plus duloxetine
Atferdsmessig: 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.
Legemiddel: Duloxetine
Participants will receive study medication - duloxetine - and take medication as directed.
Aktiv komparator: Duloxetine+PT referral
duloxetine plus physical therapy (PT) referral
Legemiddel: Duloxetine
Participants will receive study medication - duloxetine - and take medication as directed.
Atferdsmessig: PT referral
Participants will be referred to physical therapy with treatment as part of usual care and individualized to the Veteran's needs.
Aktiv komparator: Exercise+Placebo
hybrid supervised aerobic exercise plus placebo
Atferdsmessig: 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.
Legemiddel: Placebo
Participants will receive study medication - matched placebo- and take as directed.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
20-Meter Walk Test
Tidsramme: baseline, 12-week follow-up
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)
baseline, 12-week follow-up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain severity
Tidsramme: baseline, 12-week follow-up

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.
baseline, 12-week follow-up
Depressive symptoms
Tidsramme: baseline, 12-week follow-up

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.
baseline, 12-week follow-up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

VA Office of Research and Development

Samarbeidspartnere

Baltimore VA Medical Center

Etterforskere

  • Hovedetterforsker: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  • Hovedetterforsker: Alan M Rathbun, PhD MPH, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mars 2027

Primær fullføring (Antatt)

1. september 2031

Studiet fullført (Antatt)

1. september 2032

Datoer for studieregistrering

Først innsendt

10. juni 2026

Først innsendt som oppfylte QC-kriteriene

10. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RRD2-005-25W
  • 1 I01 RD002117 (Annet stipend/finansieringsnummer: Department of Veterans Affairs)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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