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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Alice S Ryan, PhD
- Numero di telefono: (410) 605-7851
- Email: Alice.Ryan@va.gov
Backup dei contatti dello studio
- Nome: Kristina Marcus, MS
- Numero di telefono: (410) 605-7000
- Email: kristina.marcus@va.gov
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Investigatore principale:
- Alice S. Ryan, PhD
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Contatto:
- Alice S Ryan, PhD
- Numero di telefono: 410-605-7851
- Email: Alice.Ryan@va.gov
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Investigatore principale:
- Alan M Rathbun, PhD MPH
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Comparatore attivo: 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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Comparatore attivo: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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20-Meter Walk Test
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain severity
Lasso di tempo: baseline, 12-week follow-up
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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
Lasso di tempo: baseline, 12-week follow-up
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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
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Investigatore principale: Alan M Rathbun, PhD MPH, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie muscoloscheletriche
- Artrite
- Malattie articolari
- Malattie reumatiche
- Sintomi comportamentali
- Osteoartrite
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Dolore
- Artrosi, ginocchio
- Depressione
- Attività motoria
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Composti di zolfo
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Tiofenes
- Duloxetina cloridrato
- Esercizio
Altri numeri di identificazione dello studio
- RRD2-005-25W
- 1 I01 RD002117 (Altro numero di sovvenzione/finanziamento: Department of Veterans Affairs)
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