- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07649291
Duloxetine and aeRobic Exercise to Improve Function in VEterans With Knee Osteoarthritis (DRIVE) (DRIVE)
Duloxetine Plus Exercise to Improve Physical Function in Veterans With Knee Osteoarthritis, Pain, and Psychological Comorbidity
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Alice S Ryan, PhD
- Número de teléfono: (410) 605-7851
- Correo electrónico: Alice.Ryan@va.gov
Copia de seguridad de contactos de estudio
- Nombre: Kristina Marcus, MS
- Número de teléfono: (410) 605-7000
- Correo electrónico: kristina.marcus@va.gov
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Investigador principal:
- Alice S. Ryan, PhD
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Contacto:
- Alice S Ryan, PhD
- Número de teléfono: 410-605-7851
- Correo electrónico: Alice.Ryan@va.gov
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Investigador principal:
- Alan M Rathbun, PhD MPH
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Exercise+Duloxetine
hybrid supervised aerobic exercise plus duloxetine
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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.
Participants will receive study medication - duloxetine - and take medication as directed.
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Comparador activo: Duloxetine+PT referral
duloxetine plus physical therapy (PT) referral
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Participants will receive study medication - duloxetine - and take medication as directed.
Participants will be referred to physical therapy with treatment as part of usual care and individualized to the Veteran's needs.
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Comparador activo: Exercise+Placebo
hybrid supervised aerobic exercise plus placebo
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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.
Participants will receive study medication - matched placebo- and take as directed.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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20-Meter Walk Test
Periodo de tiempo: baseline, 12-week follow-up
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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)
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baseline, 12-week follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain severity
Periodo de tiempo: 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
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|
Depressive symptoms
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Investigador principal: Alan M Rathbun, PhD MPH, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Síntomas de comportamiento
- Osteoartritis
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Dolor
- Artrosis, Rodilla
- Depresión
- Actividad del motor
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Compuestos de azufre
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Tiofenos
- Clorhidrato de duloxetina
- Ejercicio
Otros números de identificación del estudio
- RRD2-005-25W
- 1 I01 RD002117 (Otro número de subvención/financiamiento: Department of Veterans Affairs)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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