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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Alice S Ryan, PhD
- 電話番号：(410) 605-7851
- メール：Alice.Ryan@va.gov
研究連絡先のバックアップ
- 名前：Kristina Marcus, MS
- 電話番号：(410) 605-7000
- メール：kristina.marcus@va.gov
研究場所
-
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Maryland
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Baltimore、Maryland、アメリカ、21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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主任研究者：
- Alice S. Ryan, PhD
-
コンタクト：
- Alice S Ryan, PhD
- 電話番号：410-605-7851
- メール：Alice.Ryan@va.gov
-
主任研究者：
- Alan M Rathbun, PhD MPH
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
アクティブコンパレータ：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
20-Meter Walk Test
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain severity
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Alice S. Ryan, PhD、Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- 主任研究者：Alan M Rathbun, PhD MPH、Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RRD2-005-25W
- 1 I01 RD002117 (その他の助成金/資金番号：Department of Veterans Affairs)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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