跳至主要内容
临床试验/NCT03212300
NCT03212300终止不适用

Plasticity in Recovery From Surgery: The Effects of Exercise "Prehabilitation" on Cognitive and Functional Recovery After Shoulder Replacement in Older Adults

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年9月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Cognitive Function after surgery

研究概览

简要总结

This is a randomized study to examine whether aerobic exercise training (AET) before total shoulder replacement (TSR) surgery reduces the incidence of post-operative delirium (POD) and shorten time to recovery in elderly patients. POD is a form of sudden change in mental function that can be experienced after undergoing surgery.

详细描述

This randomized clinical trial will determine whether aerobic exercise training (AET) before total shoulder replacement (TSR) surgery reduces the incidence of post-operative delirium (POD) and shortens time to recovery in elderly patients. Delayed recovery affects up to 30% of surgical patients and imposes enormous costs on patients, caregivers, and society. Patients over 65 are four times more likely to experience POD, a form of sudden change in mental function that could be experienced after undergoing surgery. POD is associated with impaired daily functioning, longer hospital stay, more frequent institutionalization, and increased mortality.

Prevention of POD is a high clinical priority. Evidence suggests that an exaggerated inflammatory response contributes to POD. Human studies show that AET may exert anti-inflammatory effects. Furthermore, recent animal data show that AET attenuates the inflammatory response to surgery and prevents associated cognitive dysfunction.

The trial will enroll elderly patients undergoing TSR surgery to examine whether a low-cost intervention before surgery can improve clinical outcomes (reduction in POD and decrease recovery time). The effects of a 4-week AET program, specifically a type known as high-intensity interval training (HIIT), on the incidence of POD and time to recovery from fatigue and functional impairment. We will also analyze patients' immune state before and after surgery with modern techniques (high-dimensional mass cytometry). Understanding the immune-modulatory effects of AET will reveal mechanisms that can be targeted by interventions other than or in addition to exercise, which may benefit patients who are physically disabled or require urgent surgery, and help identify non-surgical diseases that may benefit from exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients scheduled for total shoulder replacement

排除标准

  • 未提供

研究组 & 干预措施

Aerobic Exercise Training (AET)

Active Comparator

20 sessions of AET over a 4 week period just prior to surgery

干预措施: Aerobic Exercise Training (AET) (Behavioral)

treatment as usual

No Intervention

standard treatment

结局指标

主要结局

Cognitive Function after surgery

时间窗: up to 12 weeks post-operatively

Cognition will be assessed using the Family Confusion Assessment Method (FAM-CAM) questionnaire to determine if there is any change

Cognitive Function after surgery

时间窗: up to hospital discharge (approximately 1 day)

Cognition will be assessed using the Nursing Delirium Screen (NU-DESC) scale to determine if there is any change

次要结局

  • Functional Recovery after surgery(up to 12 weeks post-operatively)
  • CyTOF of blood samples(Before exercise (approximately 4 weeks before surgery), after exercise (on the morning of surgery), and 1 hour, 6 hours, and 24 hours post-surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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