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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Alice S Ryan, PhD
- 电话号码:(410) 605-7851
- 邮箱:Alice.Ryan@va.gov
研究联系人备份
- 姓名:Kristina Marcus, MS
- 电话号码:(410) 605-7000
- 邮箱:kristina.marcus@va.gov
学习地点
-
-
Maryland
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Baltimore、Maryland、美国、21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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首席研究员:
- Alice S. Ryan, PhD
-
接触:
- Alice S Ryan, PhD
- 电话号码:410-605-7851
- 邮箱:Alice.Ryan@va.gov
-
首席研究员:
- Alan M Rathbun, PhD MPH
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Exercise+Duloxetine
hybrid supervised aerobic exercise plus duloxetine
|
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.
|
|
有源比较器: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.
|
|
有源比较器: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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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20-Meter Walk Test
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain severity
大体时间: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
大体时间: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
|
合作者和调查者
调查人员
- 首席研究员:Alice S. Ryan, PhD、Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- 首席研究员:Alan M Rathbun, PhD MPH、Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- RRD2-005-25W
- 1 I01 RD002117 (其他赠款/资助编号:Department of Veterans Affairs)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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