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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Alice S Ryan, PhD
- 전화번호: (410) 605-7851
- 이메일: Alice.Ryan@va.gov
연구 연락처 백업
- 이름: Kristina Marcus, MS
- 전화번호: (410) 605-7000
- 이메일: kristina.marcus@va.gov
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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수석 연구원:
- Alice S. Ryan, PhD
-
연락하다:
- Alice S Ryan, PhD
- 전화번호: 410-605-7851
- 이메일: Alice.Ryan@va.gov
-
수석 연구원:
- Alan M Rathbun, PhD MPH
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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활성 비교기: 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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활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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20-Meter Walk Test
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain severity
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- 수석 연구원: Alan M Rathbun, PhD MPH, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RRD2-005-25W
- 1 I01 RD002117 (기타 보조금/기금 번호: Department of Veterans Affairs)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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