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: 9805295
• 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/9805295
• 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 stress 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; 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; implementation strategy; 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.

有症状的膝骨关节炎 (OA) 影响 60 岁或以上的 10% 的男性和 13% 的女性，并且 抑郁症状很常见，估计五分之一的患者都患有抑郁症状。 症状会加重膝关节 OA 疾病的严重程度，并且是疼痛管理和参与治疗的障碍 临床护理指南建议对患有膝骨关节炎的老年人进行抑郁症治疗，但 没有提供如何同时管理这两种情况的指导，并且患者通常得不到治疗 他们的抑郁症状并仅针对其慢性身体疾病接受干预。 由于常规排除患有慢性身体疾病和共病抑郁症的个体而加剧 由于临床试验和缺乏为这些患者设计的方案，最近的研究提倡使用。 同时结合两种病症的治疗方法，或使用两种干预措施的治疗方法 平行的设计是为了协同工作，这样的方法可以提高超越个人的效率 治疗指南建议通过锻炼来控制疼痛和治疗。 膝骨关节炎患者的残疾并改善社会心理健康，但需遵守体育活动方案 在患有慢性疼痛和残疾的人中，这种程度较低，并且只有合并抑郁症才会使情况变得更糟。 对于使用运动训练治疗抑郁症的疗效至关重要，但目前还没有这样的运动计划 曾针对同时出现抑郁症状的 OA 患者进行设计和测试，以增强 度洛西汀是唯一适用于膝骨关节炎疼痛管理的抗抑郁药物。 在治疗老年人抑郁症时已表现出疗效和耐受性的患者，因此， 是运动训练的可行的药理学补充。目前还没有结合治疗的方案。 使用影响膝关节骨关节炎和抑郁症症状的干预措施，以及重点关注共同的战略 这两种情况的管理可以传播给全科医生并由其实施 因此，本次K01应用的研究目标是评估并进行试点测试。 方案包括有氧运动训练加度洛西汀，用于治疗症状性膝关节 OA 和 拟议的研究将在一段时期的密切指导和职业生涯中实施。 开发活动的重点是学习 1) 定性数据收集和分析的方法 用于了解患者的观点和经历以及 2) 实施策略和 临床研究干预措施的评估 该提案与 NIA 的战略方向一致。 老龄化研究强调患有多种慢性病的老年人，这些慢性病使临床护理和治疗变得复杂 旨在开展一项研究计划，利用观察流行病学评估这些关系 以及老年人肌肉骨骼疾病和共病抑郁症之间的机制，以告知 制定旨在管理原发性疾病和后遗症症状的方案。