A Feasibility and Pilot Study of Combined Treatment Protocol using Aerobic Exercise and Duloxetine in Older Adults with Symptomatic Knee Osteoarthritis and Comorbid Depression

有氧运动和度洛西汀联合治疗患有症状性膝骨关节炎和共病抑郁症的老年人的可行性和初步研究

• 批准号: 10115566
• 负责人: Alan Michael Rathbun
• 金额: $ 12.37万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-15 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10115566
• 关键词: Address; Adherence; Advocate; Aerobic; Aerobic Exercise; Affect; Aging; American; Analgesics; Antidepressive Agents; Applied Research; Chronic; Clinical; Clinical Research; Clinical Trials; Combined Modality Therapy; Complement; Data; Data Analyses; Data Collection; Degenerative polyarthritis; Diagnostic radiologic examination; Disease; Elderly; Epidemiologist; Epidemiology; Evaluation; Evidence based treatment; Exclusion; Exercise; Exercise Test; Exhibits; Feasibility Studies; Funding; General Population; General Practitioners; Geriatrics; Goals; Guidelines; Health; Health Expenditures; Health Services; Healthcare Systems; Impairment; Individual; Intervention; Knee Osteoarthritis; Lead; Learning; Logistics; Maryland; Medical; Mental Depression; Mentors; Meta-Analysis; Methods; Morbidity - disease rate; Musculoskeletal; Musculoskeletal Diseases; Observational epidemiology; Outcome; Pain; Pain management; Patients; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Physical activity; Pilot Projects; Protocols documentation; Psyche structure; Qualitative Methods; Qualitative Research; Quality of life; Randomized Controlled Trials; Research; Research Methodology; Research Personnel; Secure; Severity of illness; Site; Supervision; Symptoms; System; Testing; Training; Treatment Protocols; Universities; Woman; Work; acceptability and feasibility; base; burden of illness; career; career development; chronic pain; clinical care; common symptom; comorbid depression; conditioning; depressive symptoms; design; disability; duloxetine; exercise program; exercise training; experience; improved; intervention effect; learning strategy; men; multiple chronic conditions; patient oriented; programs; protocol development; psychosocial; recruit; skills; symptom management; symptom treatment; symptomatic improvement; treatment guidelines; treatment strategy

Symptomatic knee osteoarthritis (OA) affects 10% of men and 13% of women 60 years or older, and depressive symptoms are common, estimated to be prevalent in one-fifth of these patients. Depressive symptoms worsen knee OA disease severity and are a barrier to pain management and engagement in physical activity. Clinical care guidelines recommend depression treatment in older adults with knee OA but provide no direction on how to simultaneously manage both conditions, and patients are often not treated for their depressive symptoms and receive interventions only for their chronic physical illness. This issue is exacerbated by the routine exclusion of individuals with chronic physical diseases and comorbid depression from clinical trials and lack of protocols designed for these patients. Recent research advocates the use of treatments that benefit both conditions simultaneously, or combined treatment using two interventions in parallel that are designed to work together, such that approaches enhance efficacy beyond that of an individual therapy with a single disease target. Treatment guidelines advise exercise programs to manage pain and disability and improve psychosocial health in those with knee OA, but compliance to physical activity protocols is low in persons with chronic pain and disability and is only made worse by comorbid depression. Adherence is critical to the efficacy of depression treatments using exercise training, and no such exercise program has ever been designed for and tested in OA patients with co-occurring depressive symptoms in a way to enhance compliance. Duloxetine is the only antidepressant medication indicated for pain management in knee OA patients that has demonstrated efficacy and tolerability when treating depression in older adults, and therefore, is a viable pharmacological complement to exercise training. There are no protocols that combine treatments using interventions that affect symptoms of both knee OA and depression, and a strategy focused on co- management of the two conditions could be disseminated to and implemented by generalist medical practitioners. Thus, the research goal of this K01 application is to evaluate the feasibility of and then pilot test a protocol comprised of aerobic exercise training plus duloxetine for the treatment of symptomatic knee OA and comorbid depression. The proposed research will be implemented with a period of close mentoring and career development activities focused on learning 1) methods for qualitative data collection and analysis that can be used to understand patients’ perspectives and experiences and 2) strategies for the implementation and evaluation of interventions in clinical research. This proposal is aligned with the NIA Strategic Directions for Research on Aging emphasizing older adults with multiple chronic conditions that complicate clinical care and is intended to lead to a research program that uses observational epidemiology evaluating the relationships and mechanisms between musculoskeletal disorders and comorbid depression in older adults to inform the development of protocols that are designed to manage symptoms of both the primary condition and sequalae.

有症状的膝骨性关节炎(OA)影响10%的男性和13%的60岁或以上的女性，以及 抑郁症状很常见，估计在这些患者中有五分之一普遍存在。抑郁 症状加重了膝骨性关节炎的疾病严重程度，是疼痛管理和参与的障碍 体力活动。临床护理指南建议对患有膝骨性关节炎的老年人进行抑郁治疗，但 没有提供如何同时管理这两种情况的指导，而且患者经常得不到治疗 他们的抑郁症状，并且只接受针对他们慢性身体疾病的干预。这个问题是 由于将患有慢性身体疾病和伴发抑郁症的个人排除在外而加剧 来自临床试验和缺乏为这些患者设计的方案。最近的研究主张使用 同时使两种情况受益的治疗，或使用两种干预措施的联合治疗 并行的，旨在共同工作的，这样的方法可以提高效率，超越个人 以单一疾病为靶点的治疗。治疗指南建议锻炼计划以控制疼痛和 膝骨性关节炎患者的残疾和改善心理社会健康，但遵守体力活动方案 在患有慢性疼痛和残疾的人中，这一比例很低，而并发抑郁症只会使情况变得更糟。坚守 对使用运动训练治疗抑郁症的疗效至关重要，而且没有这样的运动计划 是否曾被设计并在伴有抑郁症状的OA患者中进行测试，以增强 合规性。度洛西汀是唯一用于膝骨性关节炎疼痛控制的抗抑郁药物 在治疗老年人抑郁症时表现出有效性和耐受性的患者，因此， 是运动训练的一种可行的药理补充。没有结合治疗的方案 使用影响膝骨性关节炎和抑郁症状的干预措施，以及专注于联合治疗的策略 这两种情况的管理可以传播给全科医生并由其实施 从业者。因此，K01应用的研究目标是评估其可行性，然后进行中试 方案包括有氧运动训练加度洛西汀治疗有症状的膝骨性关节炎和 共病抑郁。拟议的研究将在一段时间的密切指导和职业生涯中实施 开发活动的重点是学习1)收集和分析定性数据的方法 用于了解患者的观点和经验；2)实施和 临床研究中干预措施的评价。该建议与NIA的战略方向保持一致 关于老龄化的研究强调患有多种慢性疾病的老年人，这些疾病使临床护理和 旨在导致一个研究项目，该项目使用观察流行病学来评估这些关系 和老年人肌肉骨骼疾病和共病抑郁症之间的机制来告知 开发旨在处理原发病和后遗症症状的方案。