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

10 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

102

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Alice S Ryan, PhD
  • Numéro de téléphone: (410) 605-7851
  • E-mail: Alice.Ryan@va.gov

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Maryland
      • Baltimore, Maryland, États-Unis, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
        • Chercheur principal:
          • Alice S. Ryan, PhD
        • Contact:
        • Chercheur principal:
          • Alan M Rathbun, PhD MPH

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Exercise+Duloxetine
hybrid supervised aerobic exercise plus duloxetine
Comportemental: 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.
Médicament: Duloxetine
Participants will receive study medication - duloxetine - and take medication as directed.
Comparateur actif: Duloxetine+PT referral
duloxetine plus physical therapy (PT) referral
Médicament: Duloxetine
Participants will receive study medication - duloxetine - and take medication as directed.
Comportemental: PT referral
Participants will be referred to physical therapy with treatment as part of usual care and individualized to the Veteran's needs.
Comparateur actif: Exercise+Placebo
hybrid supervised aerobic exercise plus placebo
Comportemental: 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.
Médicament: Placebo
Participants will receive study medication - matched placebo- and take as directed.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
20-Meter Walk Test
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pain severity
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

VA Office of Research and Development

Collaborateurs

Baltimore VA Medical Center

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 mars 2027

Achèvement primaire (Estimé)

1 septembre 2031

Achèvement de l'étude (Estimé)

1 septembre 2032

Dates d'inscription aux études

Première soumission

10 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juin 2026

Première publication (Réel)

16 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RRD2-005-25W
  • 1 I01 RD002117 (Autre subvention/numéro de financement: Department of Veterans Affairs)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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